Coercion in mental health: a trial of the effectiveness of community treatment orders and an investigation of informal coercion in community mental health care

Background

Community treatment orders were introduced in England and Wales in 2008, despite equivocal evidence of effectiveness.

Design

The study comprised an RCT (OCTET Trial) comparing treatment on CTO to voluntary treatment via Section 17 Leave, over 12 months; an Economic Evaluation; a Qualitative Study and an Ethical Analysis. A new measure of capabilities was developed.

Methods

Trial participants were patients with psychosis diagnoses currently admitted involuntarily and considered for ongoing community treatment under supervision. The trial primary outcome was psychiatric readmission. Secondary and tertiary outcomes included hospitalisation and a range of clinical and social measures. A subsample of patients, carers and mental health professionals was interviewed in depth.

Results

A total of 336 patients were randomised. CTO use did not reduce rates of readmissions to hospital {[59/166 (36%)] of patients in the CTO group vs. 60/167 (36%) of patients in the non-CTO group; adjusted relative risk 1.0 (95% CI 0.75 to 1.33)} or any other secondary or tertiary outcome. There were no differences for any subgroups. It did not reduce hospitalisation costs and there was no evidence that it might be cost-effective. The results from in-depth interviews about CTO experiences with 26 patients, 24 family carers and 25 psychiatrists showed divergent views and that CTOs’ (perceived) focus on medication adherence may influence how they are experienced. No general ethical justification was found for the use of a CTO regime.

Conclusions

Community treatment orders do not confer early patient benefits despite substantial curtailment of individual freedoms.

Mental health care in the community

Mental health care is an international priority. 19 In the UK, expenditure on mental health care accounts for between 3% and 4% of gross domestic product. 20 Mental ill health is the leading cause of invalidity benefit in the UK21 and mental disorders are set to become the major causes of disability worldwide. 22

Psychiatry is the only area of medicine in which adult, competent patients can be treated against their will. This is governed by specific mental health legislation (in the UK, the MHA). Compulsory treatment is integral to mental health care and was originally restricted to inpatient settings. 23 Over the last 50 years or so, however, a policy focus on deinstitutionalisation has gradually moved psychiatric services from hospital settings into the community. The psychiatric inpatient population has fallen drastically in developed countries since its peak in the mid-1950s. 24 In England and Wales, for example, although there were 154,000 psychiatric beds in 1954, this had been reduced to 33,000 by 2005,25 despite the overall increase in the population. This has placed new demands on practices, policies and legislation for managing individuals with mental illness and their associated complex vulnerabilities.

Community psychiatry creates difficulties for professionals in terms of how to encourage and monitor patients to ensure both their safety and well-being and that of others. Community services may subject patients to intense levels of supervision, restrictions on their behaviour and elements of compulsion. 26 In fact, it is now commonly accepted that coercive treatment is provided outside hospitals. 27 This has been reflected in several amendments and challenges to mental health legislation over the last 30 years, as new models for more assertive treatment in the community have emerged, often monitoring patients closely while seeking to assist them to achieve stability, insight and independence. 28–30

Various provisions to maintain contact with outpatients are used where required, at differing levels of intensity and regularity as appropriate. Mental health services are increasingly delivered via case management approaches by multidisciplinary teams consisting of psychiatrists, nurses, psychologists, social workers, support workers and occasionally other professionals such as occupational therapists. 28,31,32 Such case management may be provided by the CMHT, a multidisciplinary team with diagnostically mixed caseloads (usually 1 : 25) and some provision of outreach. An alternative model, the AOT, was introduced in England from 1999,20 modelled closely on Assertive Community Treatment (ACT) teams as developed in the USA. 33 AOT teams target hard-to-engage patients with psychosis and provide much more intensive multidisciplinary outreach with small caseloads (1 : 12). These services operate within policy frameworks such as the Care Programme Approach20 and, less often, within legal frameworks provided by mental health legislation. The terms and implications of these provisions tend to vary by jurisdiction. 34,35 In England, specialist mental health services are provided by area-based UK NHS mental health trusts, each divided into catchment areas where, at the start of the OCTET Trial, community teams provided both community and inpatient care. As we discuss below (see Chapter 6, Introduction), during the recruitment phase of the trial, many trusts separated their inpatient from their community services, and CTOs were then increasingly initiated by specialist inpatient psychiatrists. 36

Community care37 has been a success for the majority of patients who have been discharged from long-term inpatient care to more dignified and rewarding lives in the community. It increasingly provides for severely disabled patients requiring complex and expensive care. 38 Despite these efforts, a substantial minority of patients are subject to repeated compulsory admissions (‘the revolving-door syndrome’39). The absolute rate of these involuntary admissions has increased following deinstitutionalisation. 40

At the same time as community mental health services have evolved, public confidence in community care has, in many countries, been profoundly undermined by a series of high-profile violent offences: usually by individuals with psychosis who, although known to mental health services, were not effectively engaged in treatment. 41 This has given rise to significant public concern about the ability of services to manage severely ill patients in the community, possibly contributing to recent trends of increasing compulsion and institutional care, with its attendant high costs. Policy-makers and clinicians have long been concerned to address such concerns about the safe management of severely ill patients. 42 In the UK, however, a number of alterations to the MHA such as Supervision Registers43 and Supervised Discharge44 are widely regarded as having achieved only limited results. The introduction of CTOs in 2008,45 described in Community treatment orders: the legislation, was designed to ensure that this group of very ill patients could be more successfully monitored and treated.

Detailed accounts of the literature on CTOs also appear in papers by members of the OCTET Coercion Programme Group. 17,18

Compulsion in community mental health care

In attempting to increase patients’ adherence to treatment and thereby improve their outcomes, mental health professionals use a range of formal and informal techniques. (We discuss informal techniques, or informal coercion, in Part 4, Chapter 17.) At the formal end of the spectrum, legislation for compulsory outpatient psychiatric treatment (compulsion) has been introduced in around 75 jurisdictions worldwide, across the USA, Australasia, some Canadian provinces, the UK and several other European countries. 4

Community treatment orders were designed with the aim of helping so-called revolving-door patients: those who have a long history of psychotic illness and experience multiple hospital admissions. They were principally aimed at preventing this revolving-door scenario by helping patients experience a period of stability after leaving hospital.

Community treatment orders were introduced in England and Wales in November 2008. 45 CTOs require patients to accept treatment and clinical monitoring, and allow rapid recall to hospital when necessary, as is described more fully in Community treatment orders: the legislation. This provision had been sought for at least 15 years by some professionals,46 but it was heavily debated and resisted during the build-up to its introduction by a coalition of 32 professional and patient organisations. 47

Community treatment orders: the legislation

The introduction of CTOs in England and Wales in 2008, as part of the amended MHA 2007,45 marked the next step in this evolution of forms of compulsory treatment in the community. This regime authorises compulsory treatment for patients in the community following a period of involuntary hospital treatment. Enforcement is provided via the power of recall, which permits patients to be returned to hospital for treatment or assessment without conducting a formal MHA assessment. The intention is to prevent relapse or harm (to self or others), help maintain a period of stability and provide a least restrictive alternative to hospital (i.e. one in which the intervention given restricts the patient’s freedom the least). 48

A CTO can be imposed when the responsible clinician (RC) (usually a consultant psychiatrist) and an approved mental health professional (AMHP) (usually a social worker) deem that a patient needs supervision after a period of involuntary hospital treatment and that, without it, he or she is highly likely to relapse and be readmitted involuntarily. The AMHP is required to consult with the patient and with family carers. The formal process is intentionally time-consuming to ensure that the CTO is not used for clinical convenience. Several days, sometimes more, elapse between the clinical decision and CTO activation. Alternatively, RCs may choose to use Section 17 Leave (described above). Unlike with Section 25, CTOs can insist on medication. Medication cannot be given by force in the community, however, regardless of whether or not a CTO or Section 17 Leave is used. Forceful administration is permitted only if the patient has been recalled to a ‘safe place’. Patients can be discharged directly from Section 3 without the need for either Section 17 Leave or a CTO, and most are. (Such patients would not be eligible for recruitment to this trial.)

The CTO requires the patient to comply with treatment and he or she can be recalled to hospital without delay if necessary. The regime in England and Wales specifies two mandatory conditions that apply to all CTOs. 48 First, a second opinion appointed doctor (SOAD) must assess patients who refuse medication or who lack capacity, to confirm that the treatment specified is appropriate. 50 Second, all patients must make themselves available for assessment for renewal of the CTO. The RC and AMHP who initiate the CTO may also specify discretionary conditions based on their knowledge of an individual patient. The most frequently stipulated conditions are to take prescribed treatment and remain in contact with the mental health team. 51–53 The power of recall can be used when the patient:

• requires treatment in hospital and in the absence of recall there would be a risk of harm to self or others, or

• does not comply with one of the mandatory conditions.

Recall can be used for the purpose of giving treatment or for assessment for up to 72 hours, after which the patient returns to the community under the CTO or the CTO is revoked and the patient remains in hospital for involuntary treatment under Section 3 of the MHA. The MHA Code of Practice states that patients and their families should be consulted about the CTO, its conditions and the need to recall, not least because family carers are likely to hold information of importance. 48

A CTO is imposed for up to 6 months in the first instance and is then renewable for a further 6 months and subsequently for 1-year terms; frequent clinical monitoring was anticipated in the Code. 48 It can be discharged at any time by the RC or by a Mental Health Review Tribunal (MHRT) if the patient’s mental state or circumstances change. During the period covered by the CTO, the hospital treatment order (Section 3) remains in place but is inactive; it is reactivated if the CTO is revoked after a recall to hospital (Box 1 and Figure 2).

FIGURE 2.

The CTO process.

BOX 1 - The CTO regime in England and Wales

Community treatment orders were introduced via a 2007 amendment to the MHA for England and Wales, with effect from 3 November 2008. They are referred to in the Act under the heading of supervised community treatment.

To be placed on a CTO, a patient must fulfil all the following criteria:

• suffering from a mental disorder of a nature or degree which makes it appropriate for them to receive medical treatment

• it is necessary for that person’s health or safety or for the protection of others that the person should receive treatment

• treatment can continue in the community without the person being detained in hospital

• it is necessary that it be possible to recall that person swiftly to hospital if needed

• appropriate medical treatment is available.

The order is made by a responsible clinician (usually a psychiatrist) and an approved mental health professional (usually a social worker). The order lasts for 6 months initially, can be renewed for another 6 months and thereafter for 12-month periods. The responsible clinician can end the order when clinically indicated, and it may also be ended by the managers of the treating hospital or the MHRT.

The order includes two mandatory conditions. Patients on CTOs must make themselves available:

• to be assessed by a second psychiatrist to complete the mandatory peer review process concerning treatment without consent, when required

• for assessment concerning renewal of the CTO.

The RC and AMHP may also specify discretionary conditions that are needed to ensure the patient receives medical treatment, or to prevent risks of harm to the patient or others, based on their knowledge of an individual patient. These may subsequently be varied by the RC.

Patients on CTOs may be recalled to hospital for up to 72 hours when they:

• breach the mandatory conditions, or

• require further treatment in hospital and there would be a risk of harm to self or others if they were not recalled.

Recall can be used for assessment or to provide treatment without consent. When 72 hours have elapsed, the patient returns to the community under the CTO, remains in hospital for involuntary treatment under Section 3 of the MHA or is discharged from involuntary care under the MHA.

Section 17 Leave remains an available option under the new law, but since the amendment to the MHA, clinicians must consider using a CTO instead if they are granting leave for more than seven consecutive days, as is stated in the Code. This change, along with the removal of supervised discharge, signalled that the government saw CTOs as the primary means of providing involuntary supervision in the community.

Controversy surrounding community treatment orders in England and Wales

The introduction of supervised community treatment was highly controversial and was preceded by a heated debate lasting for at least 15 years. In other countries there had been similar levels of debate and controversy,54 but when the orders were made available, they were incorporated into practice swiftly. Initial proposals in England and Wales were met with broad opposition from service users, psychiatrists and mental health charities. The amended proposals, once enshrined in law, continued to provoke vigorous debate and to divide the psychiatric profession. Some viewed CTOs as ethically unacceptable because of the infringement of rights and freedoms. 55 Others believed they were potentially beneficial to patients and their families4,56 or argued that they constituted only a minor amendment to current law or practice. 25

The arguments emphasising individual human rights and people’s rights to make lawful decisions about their own lives were particularly forceful. This position provided powerful arguments against coercive treatment6 but was vulnerable to the criticism that such a purely rights-based approach could leave revolving-door patients in unacceptable circumstances, preventing them from improving their lives. Not to pursue compulsory interventions could be seen as conflicting with mental health practitioners’ primary obligation to help. 6

Much of the debate centred on issues of an individual’s capacity to make decisions about his or her treatment. Such competence might, of course, be compromised or even absent in those with severe mental illness. Others might have to make decisions on their behalf. This would require good knowledge about the person’s values and opinions based on when he or she had full capacity. It is commonly viewed as appropriate that when the patient’s views are not available, ‘best-interest’ standards should be applied. 6

It has been argued that although politicians sought to introduce CTOs in order to address the public’s fear of crimes committed by people with mental health problems, the protection of society is an insufficient reason to justify detention. 57 This is particularly the case given the difficulty in predicting serious violence by those with mental health problems. 58 The ‘principle of reciprocity’ requires that restrictions of civil liberties must be matched by the provision of adequate and high-quality services. 27,57 This was one of the underpinning principles of the amended MHA in Scotland, which introduced compulsory powers in the community in 2005. 59 Some have suggested that the use of compulsion may be enabling and consistent with the recovery model if adequately resourced and accompanied by clear goals for treatment and progress. 3

The change in the law in England and Wales was thus highly controversial. A fierce debate continued about how it impacts on patients’ lives and mental health services. It was argued, for instance, that even if compulsion in the community may be necessary in itself, CTOs in the form introduced in the 2007 MHA may not be in patients’ best interests. In particular, the following issues were identified that needed to be resolved:

• whether or not capacity should have been a fundamental principle of the new MHA

• whether or not having CTOs would increase the overall level of coercion

• whether or not CTOs would contribute to better outcomes

• which patient groups might benefit from CTOs and in what ways

• whether or not it might be relatively easy to be placed on a CTO but harder to get off one (a lobster pot effect), leading to an inexorable rise in numbers over time

• whether or not potential benefits would justify the restrictions in civil liberties. 17

Evidence base for community treatment orders

Although early opposition to CTOs focused on civil liberties6 or lack of improvement on the existing leave regime,25 more recent opposition has emphasised the absence of experimental evidence. 3,60

Around 40 published non-randomised studies have investigated CTO effectiveness by measuring outcomes, particularly in Australia, New Zealand, the USA and Canada,3,4,61,62 but prior to the OCTET Trial there had been only two published RCTs. 63,64 Most of the studies have methodological limitations. 65 It is therefore problematic to generalise from these findings. Generalisability is also problematic because of significant differences between the contexts into which CTOs have been introduced, such as the mental health systems and legal procedures. Neither of the two RCTs demonstrated a difference in the primary outcome measure of readmission rates, as detailed below.

The most common research designs used in studies of CTOs conducted prior to the OCTET Trial (which have been reviewed in detail by Dawson,4 Churchill et al. 3 and by the OCTET Coercion Programme Group18,66,67) have been controlled before-and-after (CBA) studies and uncontrolled before-and-after (UBA) studies, in which patient outcomes are compared before and after the intervention. Some epidemiological studies have also been conducted in which CTO and non-CTO populations have been observed but not matched. Studies using routine administrative data in this way have the advantage of including data on all CTO patients in whole areas or jurisdictions, avoiding selection bias following from excluding, for instance, violent or non-consenting patients.

How to measure relevant outcomes

There have been different opinions on what constitutes the best measure to assess the outcome of CTOs. This relates to whether the chief purpose of CTOs is considered to be prevention of relapse or the provision of a least restrictive alternative. Readmission to hospital has been the most widely used outcome measure of success in preventing relapse in patients with psychosis. The term relapse has different meanings in the literature and no unambiguous measure of it has emerged. Readmission is the measure that has been the most consistently used, not only as the primary outcome of the two RCTs, but also in most of the non-randomised studies. It has also been widely used as the primary outcome measure in most antipsychotic maintenance trials. 85 Measures obtained directly from patients have been vulnerable to attrition and difficult to standardise. Despite criticism of it as being a crude proxy for relapse, readmission is a measure for which data are obtainable. A binary measure of readmission, excluding brief recall or breach admissions, where they are permitted, may be least sensitive to particularities of service organisation and other contextual issues. (This was the primary outcome measure we used in our trial; see Chapter 6, Methods.) When recall admissions are not routinely distinguished, it may be difficult to ascertain the effect of CTOs. Similarly, frequent contact with the community team may indicate that the CTO is working, whereas contact with a crisis team may suggest relapse, and these situations must be carefully distinguished. 67

Some have argued that the duration of admission should be the preferred measure because shorter admissions may reduce the overall restrictiveness of CTOs. Duration of admission does measure relapse, but it also measures the clinical response to that relapse. Although duration of admission conveys important information, it does not measure the effectiveness of CTOs in their purpose of stabilising patients in the community and reducing or preventing relapse. It may therefore be more suitable as a secondary measure (as we used it in our trial; see Chapter 6, Methods). It is of obvious importance in cost-effectiveness studies.

The outcomes most frequently measured in the existing literature include readmission rates, time to readmission, duration of admissions and use of community services. The ways in which these outcomes have been measured has varied. Duration of admission, for example, has been measured by the number of days from admission to release from hospital for each episode,86 and as the patient’s mean number of days in hospital during months in which a hospitalisation occurred, compared across 6-month periods. 87 Other outcomes, such as medication possession, adherence, victimisation, arrest, mortality and quality of life, have been measured in some studies. 3,81 This means that the total number of outcome measures applied has been rather large for a relatively small body of research.

The clinical ambition of a CTO is to foster longer-term changes in patient well-being and insight as a result of a protracted period of treatment. Churchill et al. 3 argue that ‘if CTOs are intended to improve outcomes for patients, then . . . patient relevant outcomes should be prioritised in future research.’ Their review reveals the paucity of data on such patient-level outcomes as symptoms, social functioning, quality of life and satisfaction. Churchill et al. 3 also argue for the inclusion of measures of perceived coercion, found to be associated with CTO use in the literature, which they argue may be mediated by factors such as treatment adherence and therapeutic relationship. In fact, measuring perceptions of the therapeutic relationship and the patient’s experience of the service may be particularly important given the indications in the literature that the use of CTOs may threaten the patient–professional relationship, although Churchill et al. 3 note that ‘the impact and duration of such problems have not yet been properly investigated’.

The literature on CTOs suggests that any effect of CTOs on admission to hospital may be achieved by improving treatment compliance. Although, as noted above, there is no robust evidence to support either contention, it is clearly important to understand the factors that might affect treatment compliance or engagement. Churchill et al. 3 note the emphasis in the literature on insight, or awareness of the need for treatment, along with other factors such as previous experience of the mental health system (including coercion) or poor access to services.

In designing the most robust possible study of CTOs, there is thus a clear need to include data on patient-level outcomes such as these. As well as the hospitalisation outcomes described above, the OCTET Trial used well-established measures of clinical and social outcomes, attitudes to medication and experiences of services and of coercion, including measures of insight and therapeutic relationship (see Chapter 6, Methods). We also identified a need to develop a measure capable of capturing quality of life for people with severe mental illness, in particular one that would capture their capabilities (things that they are free to do or be). We therefore developed and tested such a measure as part of the OCTET Study (see Chapter 10) and it was utilised as part of the Economic Evaluation (see Chapter 7).

Ethical implications of community treatment orders

Ethicists studying CTOs have largely been critical of what has been taken to be a new paternalistic approach to the delivery of community-based mental health services. Instigating involuntary outpatient treatment into patients’ care regimens outside of hospital has been argued to constitute an unjustified restriction of patients’ personal freedoms and autonomy, undermining the principles of respect for liberty and self-determination. 6,88,89 These ethical arguments have moved beyond the use of catch-all normative concepts such as coercion, and have been accompanied by a more general recognition of, and concern about, the use of a range of pressures to influence patients’ adherence to treatment within community mental health settings, as investigated in the ULTIMA Study.

In response to these principle-led attacks on the justification of CTOs, other commentators have offered spirited defences of the new legal powers by highlighting the difficult realities of the lives of those patients who have severe illnesses that undermine treatment adherence and frequently require readmission to hospital. Established to support these so-called revolving-door patients in ways that could secure the longer-term positive outcomes associated with continued treatment and prompt intervention in the face of crisis, CTOs have been claimed to be liberty enhancing and potentially beneficial to those in receipt of them. 90,91

Although the ethical discussion has begun to take seriously the realities of the treatment settings within which CTOs are used, the academic psychiatric literature continues to scrutinise whether or not the ethical considerations identified can be balanced in such a way as to defend the use of CTO regimes in different jurisdictions. Moreover, little is known about how these considerations translate into practice, given the complex and varied mental health and social support needs of the patients who will be subject to these powers. The empirical studies that have explored the experiences of mental health professionals and patients have highlighted positive and negative views about the use of CTOs in practice,73,77,92 but the authors of these studies have not sought to explicate their findings in ways that directly address the ethical questions that concern the use of this new legal power. These complex ethical considerations provided the starting point for the ethical analyses conducted in the OCTET Coercion Programme.

Host/sponsor

The study protocol was reviewed and approved by the research and development (R&D) office of the then Oxfordshire and Buckinghamshire NHS Mental Health Foundation Trust (from March 2011, Oxford Health NHS Foundation Trust). The trust accepted its role as study sponsor and issued the necessary indemnity documentation.

Ethical approval

Details of ethical approval are given above (see Part I, Chapter 4). During the course of the study, seven amendments to the original protocol were sought and approved (see Appendix 1). All were communicated to all participating trusts.

Steering group and data monitoring committee

The OCTET Study Steering Group consisted of an independent clinician, a service user, a service user organisation representative, a carer representative and a mental health lawyer. Its function was to advise on the implementation process and on how to translate our findings into policy and practice.

The OCTET Trial also had a data monitoring committee (DMC) as part of its governance structure, as is a prerequisite for all high-quality RCTs. The purpose of a DMC is to judge at agreed intervals whether or not it is ethical and desirable to continue with the trial, by examining reports of interim data. The DMC is asked to assess on the basis of these reports whether or not the trial should be stopped because:

• there are unanticipated adverse outcomes clustered in one arm, or

• the result is already clear (i.e. there is a statistically clear advantage to one arm because of a very large effect size).

It was anticipated in the OCTET Trial protocol that the first report could be delivered for the committee’s consideration 12 months after the study’s inception. Recruitment was delayed, however, by delays in obtaining R&D approval and negotiating researcher access in the participating NHS Trusts, so at 12 months we had follow-up data for only about 30 patients. This was deemed insufficient to give any meaningful indication as to the trial’s progress. With the agreement of the DMC, we therefore decided to postpone the first report to 18 months and the second to 24 months after the study’s inception. The statistical data were prepared by a statistician who was independent from all data collection. Although the OCTET research team assisted in her work, in particular by preparing the background information, they were kept blind from all calculations of outcome data. The committee reviewed the project at the agreed time points and saw no reason to stop the trial.

The composition of the OCTET Steering Group and DMC is given in Appendix 5.

The need for a randomised controlled trial of community treatment orders

As the Introduction to this study made clear, CTOs were highly controversial when they were introduced and have remained so (see Chapter 5). The key issues of contention in the period before their implementation included:

• ethics – whether or not CTOs ought to be enacted

• legality – whether or not CTOs would comply with constitutional and/or human rights

• empirical issues – whether or not established CTO schemes had the intended beneficial outcomes.

The only methodology which could convincingly address concerns about the effectiveness of CTOs was an RCT. We therefore designed the OCTET Trial to:

• provide rigorous evidence to inform the debate about CTOs

• demonstrate whether or not adding CTOs to community care reduced readmission rates and affected a range of other outcomes

• identify patient characteristics and care patterns associated with positive and negative outcomes

• inform an economic evaluation.

This chapter draws substantially on papers by members of the OCTET Coercion Programme Group: the trial protocol summarised in The Lancet (Burns et al. ,93 with permission from Elsevier); its primary and secondary outcome findings as published in The Lancet (Burns et al. ,16 with permission from Elsevier) and the tertiary outcome and subgroup findings (Rugkåsa et al. ,94 with permission from John Wiley & Sons).

Development of the Trial design: consultation exercise

The aim of the OCTET Trial was to compare CTO use to voluntary outpatient treatment. A number of ethical, legal and practical issues rendered this a complex undertaking.

In view of concerns being raised about the ethical, legal and practical issues of methodologies to test the impact of CTOs, we conducted a consultation exercise with clinicians and legal, policy and ethical groups in the spring and summer of 2008, before finalising the protocol for the OCTET Trial. As is reported below, the exploratory work on the legal constraints involved led to our seeking a detailed legal opinion; we report this separately (see Chapter 11).

This detailed consultation exercise involved numerous opportunistic discussions and a series of more structured meetings to explore the ethical, legal, clinical and practical aspects to the proposed study methodology and to obtain agreement about, and support for, the strongest test of the intervention, in order to produce a detailed study protocol. The consultation exercise involved > 50 people from the full range of stakeholders from the following groups:

• patients and carer organisations and mental health voluntary organisations

• MHA practitioners

• mental health lawyers

• academic legal experts

• the MHRT

• approved social workers

• clinicians in inpatient and outpatient services

• ethicists.

There were some differences between the different groups of stakeholders, in particular between those working with patients in a clinical capacity and those who practised mental health law as solicitors or as representatives of the MHRT. Here we summarise the views expressed by each group, in turn. The summaries represent the breadth of views in each group and the main points, from across the groups, which were of relevance to the trial’s feasibility and design. It should be noted that this consultation was conducted after the legislation had been passed by Parliament in 2007 but prior to the actual introduction of CTOs on 3 November 2008, so none of the consultees had any practical experience of the new regime.

Overview of the OCTET Trial

Design

The OCTET Trial was a single-outcome, parallel-arm, non-blinded randomised trial. Its primary objective was ‘to conduct the most rigorous trial possible of CTOs with prolonged, high-quality care incorporating a broad range of outcomes, and identify patient and service predictors of response’. Our aim was to compare CTO use to voluntary outpatient treatment. This aim was modified on the basis of the legal analysis, as explained above. Our trial therefore randomised the patients to leave hospital either on a CTO or via Section 17 Leave. There was an understanding that for patients in the non-CTO arm, Section 17 Leave was to be used according to the MHA Code of Practice48 and be restricted to a short period of days, or at most weeks, before discharge to voluntary care took place. The trial thus randomly assigned patients to receive one of two forms of mandatory outpatient care at the point of discharge from inpatient care: the two main options for clinicians regarding patients who needed ongoing supervision in the community from November 2008 onwards. Patients were assessed at baseline, and at 6 and 12 months, and the primary outcome measure was readmission to hospital, as detailed below and represented in the OCTET flow chart (Figure 3).

FIGURE 3.

The OCTET Trial procedure.

Taking into account the findings from the North Carolina RCT,64 which suggested a correlation between outcomes and the combination of duration of CTO and intensity of services, we designed the OCTET Trial so that patients in both arms would receive approximately weekly contact with services. This was in line with common practice for this group of patients in English services.

Recruitment of trusts, teams and patients

Sample

Recruitment took place from 10 November 2008 to 22 February 2011.

Eligible patients were those:

• aged 18–65 years (in line with local administrative procedures for adult mental health services)

• diagnosed with psychosis

• currently admitted under Section 3 or Section 37 (without restrictions) of the MHA

• not currently subject to any other legal restrictions

• judged by their clinicians (RC and AMHP) to need ongoing community treatment under supervision

• able to consent to take part in research and give written and informed consent

• not participating in the study already (i.e. patients with multiple admissions throughout the recruitment period should participate in the study only once).

We did not exclude patients with insufficient English language to complete the interview. As the research instruments were not validated in different languages, these patients could not be interviewed, but we collected data from their medical records and invited them to take part in the Qualitative Study in their own language.

Patients were not eligible if they were:

• unable to give informed consent (e.g. advanced dementia or mental disorder too severe)

• subject to incompatible legal restrictions on treatment

• considered to be clear candidates for immediate discharge to voluntary treatment

• already on Section 17 Leave for > 30 days.

We invited mental health professionals to complete questionnaires about their therapeutic relationships with the patient and the patient’s quality of life if they were:

• currently the care co-ordinators of the recruited patient and employed by the NHS at baseline and/or 12 months

• providing care for the recruited patient (for at least the past 3 months).

We originally intended to recruit family carers of the sampled patients to undertake a questionnaire survey at the 6-month follow-up point. We later decided to omit this, however (see Changes to protocol from original proposal).

Objectives and hypotheses

The primary objective of the OCTET Trial was to test the hypothesis that patients with psychosis and a history of compulsory admissions in the CTO arm of the trial would experience a reduction in readmissions to hospital compared with those not placed on a CTO. The secondary and tertiary objectives were to investigate whether or not such patients would experience a greater delay to readmission, shorter admissions or improvements in a range of clinical and social outcomes.

The exploratory objectives of the trial were to identify the baseline characteristics of patients associated with differential treatment effects; to examine the factors (other than treatment group) associated with readmission; and to explore the effect on readmission of process variables such as rate of contact.

Cost-effectiveness was also evaluated and this is reported separately (see Chapter 7).

Sample size and power calculation

The North Carolina trial64 demonstrated a difference of 16% in the proportions readmitted to a psychiatric hospital within 12 months (32% in the group under outpatient commitment vs. 48% in the control arm). We calculated that to detect a similar difference with a significance level of 5% and power of 80%, assuming that rates of readmission would be comparable in our control group, would require a sample size of 288 patients. We predicted that attrition would be negligible, as primary outcome data would be available from medical records. With this number of patients, we calculated that we would also be able to detect either of the following differences as statistically significant at the 5% level with 80% power:

• a 14-day difference in the mean number of days spent in hospital over 12 months (e.g. a reduction of 28 days to 14 days)

• a difference of 0.43 in the mean number of readmissions over 12 months.

Data collection

We collected data from medical notes and structured patient interviews with independent, trained researchers at baseline and at 6 and 12 months. Detailed assessments included demographics, clinical history, prior MHA use and criminal justice history. We assessed current status using well-validated and widely used structured questionnaires, as detailed in Instruments. The researcher read out the questions and recorded the patient’s replies. The full assessment battery took between 45 and 90 minutes to complete. We pursued notes from other teams or hospitals or from MHA offices when applicable. In all cases, we collected all primary outcome data from Trust information systems. We collected data on diagnosis and current medication from case notes. We also confirmed data on sociodemographics and psychiatric history, collected in the Socio-demographic Schedule (see Instruments), from case notes.

We collected 6-month data for use in the analyses along with the 12-month data, but did not intend to report them independently. We used the three data points in order to have sufficient power for the modelling of the within-patient variability in the multilevel analysis. Collecting 6-month data also ensured that the research team was able to keep in contact with the patients and as a safety net in case there proved to be significant difficulties in follow-up at 12 months.

Outcomes

We chose outcome measures for the trial based on the evidence in the literature about the most appropriate hospitalisation outcomes to capture the outcome and process of CTOs, as well as relevant clinical and social functioning outcomes (see Chapter 5, Background). We chose the rate of readmission as our primary outcome because CTOs had been legislated explicitly for this outcome. It was the primary outcome in most major studies,3,4,61 including the only two published randomised trials. 63,64 It is also accepted as the best measure for relapse prevention85 and therefore a proxy for community stability.

The primary outcome measure was therefore psychiatric readmission in the 12-month follow-up period, as a binary outcome. We defined a readmission as the period between the patient’s admission date and the date on which the patient left hospital, which should include at least one overnight stay. Readmissions could be either voluntary or involuntary. We did not classify recall to hospital of a patient on a CTO as a readmission, as it was understood as being part of the CTO process rather than an outcome. If a recall ended in the CTO being revoked, we counted this as a readmission, calculated from the first day of the recall. The follow-up point was defined as 365 days after randomisation (referred to below as ‘follow-up’).

Secondary outcomes related to readmission followed the same readmission definition and constraints. We mainly obtained these from medical records. They represented patterns of readmission, as follows:

• number of nights in psychiatric hospital from randomisation (index) to follow-up

• days in community until first readmission

• number of readmissions from first discharge to follow-up, per patient

• days under legal compulsion (measured by time being subject to the MHA 2007 under Sections 2, 3, 4, 37, 48, 49, 135, 136 or on a CTO) from randomisation (index) to follow-up

• number of patients with multiple readmissions.

Tertiary outcomes were mainly self-reported patient outcomes. These were:

• clinical and social outcomes

• medication

• experiences of and satisfaction with services

• experiences of leverage and perceived coercion

• employment.

Safety outcomes were covered by self-reported items in the clinical research forms. Additional safety outcomes included death and cause of death.

Instruments

We utilised the following instruments with patients to measure the outcomes detailed above. Unless otherwise specified, they were patient rated at baseline and at 6- and 12-month follow-up, and relate to the 6-month period prior to interview.

Outcome data from medical records

We collected outcome data on readmissions and MHA use from patients’ medical records. This included questions on legal status (whether under section or not), CTO recalls and conditions (both over 12 months), tribunals and managers’ hearings. We also pursued notes from other hospitals and from the criminal justice system where applicable.

Blinding

It would, of course, be impossible to blind clinicians or patients in a trial for which knowledge of the intervention is part of the intervention itself. Moreover, it would be unlawful not to inform each party of legal status. It was not possible to blind researchers to randomisation. Research assistants were blind to randomised status during the baseline assessment.

Randomisation and masking

Randomisation was a stratified block design with a 1 : 1 allocation ratio. Eligible patients had an equal probability of assignment to each arm of the trial. Patients were randomised individually to either the CTO or the non-CTO arm by an independent statistician using stratified block randomisation for gender (male/female), schizophrenic status (yes/no) and duration of illness (< 2 years, ≥ 2 years). We developed the randomisation code using a computer random number generator to select random permuted blocks. The block lengths were two, four and six, varied randomly.

A researcher independent to the trial team enclosed assignments in sequentially numbered, opaque, sealed envelopes and stored them. The details of the sequence remained unknown to all members of the trial team until recruitment, data collection and analyses had been completed. The sealed envelope was labelled with the stratum number, gender, schizophrenic status, duration of illness and an envelope number. A matching label inside, also numbered, specified the intervention arm. Randomisation took place after consent had been obtained and the baseline interview had been performed. The envelope was opened on the day of the interview by the independent researcher after recording the patient’s trial identification number on the envelope. She then communicated the randomised allocation to the recruiting researcher by telephone. As randomisation involved allocation to different legal statuses, it was both impossible and unlawful to mask research assistants, treating clinicians or patients.

Protocol violations

Protocol violations were predefined as arising when patients were:

• withdrawn

• ineligible

• discharged to the wrong treatment arm

• never discharged from hospital.

Patients who were protocol violators of any of these predefined types were included in our intention-to-treat analysis. We counted those patients who never left hospital during the follow-up period as having had one readmission of 365 days.

Statistical methods

All analyses were performed using Stata/SE version 12 (StataCorp LP, College Station, TX, USA).

The trial team wrote and signed off a detailed statistical analytical plan before any data were analysed (see Appendix 2). All analyses were done according to the analysis plan. Blinding of the statistical analysis, methods for dealing with outliers, missing data, computation and methods are detailed there.

Data management

The researchers recorded data in the clinical research forms by hand and two different researchers double-entered them into IBM SPSS version 20 (IBM Corporation, Armonk, NY, USA). Double-entered data were compared against each other, and discrepancies were discussed and corrected by the research assistants under supervision. The statistician responsible for the analysis conducted additional data quality evaluations. These included range checks and logical and consistency checks that might not be picked up by checks at the individual patient level by the research staff who collected and entered the data. In the case of variables that were a function of other variables (e.g. length of a particular readmission), these were checked by automatic calculation of the variable’s values, except for total scoring of the individual instruments, which was performed automatically using a validated code. We froze the final cleaned data before analysis commenced.

Changes to protocol from original proposal

Recruitment

We recruited patients from 32 trusts to the trial, predominantly in the Midlands and southern England (Figures 4 and 5).

FIGURE 4.

Recruiting counties.

FIGURE 5.

Recruitment rates in participating NHS mental health trusts in England.

The study team assessed 442 patients in total, of whom we recruited 336. The 106 patients who were not recruited after being approached either refused (n = 91), were found not to be eligible (n = 6) or lacked capacity (n = 9) (Figure 6). The Ethics Committee did not grant us permission to collect any data on those who refused to enter the study or were considered for referral to the study by their clinicians but then not referred.

FIGURE 6.

Trial profile. a, Including three patients deceased during follow-up period; b, including two patients deceased during follow-up period. Reproduced from Burns T, Rugkåsa J, Molodynski A, Dawson J, Yeeles K, Vazquez-Montes M, et al. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. Lancet 2013;381:1627–33,16 with permission from Elsevier.

Participant flow

Participant flow is presented in our CONSORT (Consolidated Standards of Reporting Trials) diagram (see Figure 6). The 336 recruited patients were randomly assigned to either the CTO arm (167 patients) or the non-CTO (169 patients) arm of the trial. One patient withdrew and two patients were identified as ineligible directly after randomisation.

Sample: baseline data

Baseline sociodemographic data and data on psychiatric and legal history are shown in Table 2. Of the 336 patients included in the final data analyses, 225 (67%) were males. The vast majority (n = 316, 98%) were not employed. The majority of the patients (n = 206, 61%) were white, with 78 (23%) being black. The majority (n = 259, 77%) had been born in the UK. They had received 12 years of education on average. The majority (n = 241, 72%) were living in independent accommodation and were living alone or homeless (n = 239, 75%). Only a minority (n = 112, 37%) had an identified carer. They had been ill for 12 years on average, with only 14 patients (4%) having been ill for < 2 years. They had experienced an average of four involuntary psychiatric hospital admissions in the past and reported that they had spent a total of 15 months in psychiatric hospital in their lifetime. A substantial minority (n = 133, 40%) had criminal convictions and just over one-quarter (n = 86, 26%) had previously been in prison (see Table 2).

Table 3 shows baseline values of clinical characteristics, experiences of services variables and experiences of leverage and perceived coercion. The majority (n = 286, 85%) had a primary clinical diagnosis of schizophrenia. The sample was only mildly to moderately symptomatic (BPRS, median: 38), as would be expected for patients being discharged to the community following successful inpatient treatment. They were a significantly impaired group, however, in terms of their functioning (GAF, mean: 39). Five patients (2%) screened as positive for alcohol or drugs. The sample reported a fairly low level of overall social outcome (SIX, mean: 2.5). They had fairly high levels of insight (ITAQ, median: 13.5), including more positive attitudes to treatment but less awareness of illness (medians: 9 and 6, respectively). The majority (n = 265, 79%) were on oral medication, a small minority were prescribed clozapine (Clozaril, Novartis, Basel, Switzerland) (n = 43, 13%) and a substantial proportion (n = 188, 56%) were on depot medication. They reported somewhat negative attitudes and adherence to medication (DAI-10, median: –2), which was mainly first generation antipsychotic medication.

Patients reported their therapeutic relationships to be fairly positive (STAR-P, mean: 30.3), with similar levels across the three subscales. They reported fairly neutral attitudes to being involved in clinical decision-making (API, mean: 56.6) but a greater desire to be informed about their illness and treatment (API, mean: 76.5). They were fairly satisfied with services (CSQ-8, mean: 21.3).

Seventy (23%) of the patients reported having had experience of leverage in the previous 6 months. They rated their care as fairly coercive (Perceived Coercion Scale, mean: 14.8) and reported that they had experienced a fairly high number of negative pressures (Negative Pressures Scale, mean: 14.5). They reported not having much of a say in their own care (Procedural Justice Scale, mean: 8.4). They regarded the treatment pressure they had experienced as only moderately fair (Index of Fairness, mean: 12.8) and effective (Index of Effectiveness, mean: 12.3) (see Table 3).

Baseline characteristics did not differ between those who were interviewed at 12 months and those who were not (Table 4).

Protocol violations

It was impossible to control for protocol violations, as clinical decision-making needed to be unconstrained by the study design for the trial to be lawful (see Introduction/Overview of the OCTET Trial). The treatment of 35 patients in the CTO arm and 40 in the non-CTO arm (22.5% of the whole sample) did not follow the randomised status: these 35 patients from the CTO arm of the trial were never put on a CTO, whereas the 40 patients from the non-CTO arm were put on a CTO directly after leaving hospital. Seven further patients from the CTO arm of the trial and six from the non-CTO arm were never discharged from hospital, making a total of 42 protocol violations in the CTO group and 46 in the non-CTO group: 88 in total. Combined with the three patients who were withdrawn or ineligible, this made a total of 91 protocol violations (Table 5).

Primary outcome

There was no difference in the primary outcome of psychiatric readmission in the 12-month follow-up period between the two groups, with 59 and 60 patients readmitted in the CTO and non-CTO groups, respectively (see Table 6).

Secondary and major clinical outcomes

There were no differences in any of the secondary hospitalisation outcomes between the two groups or in the major clinical outcomes of symptoms and functioning. At 12 months, neither the total duration of all psychiatric hospitalisations, nor the number of readmissions per patient, the number of patients experiencing multiple readmissions and the number of days spent in the community until the first readmission differed between the two groups (Table 6). (Time to first readmission is also presented in Figure 7.) The pattern of duration of individual readmissions was similar for each group (Figure 8). Neither severity of symptoms nor social functioning differed between the groups at 12 months (see Table 6).

FIGURE 7.

Time to first readmission. Reproduced from Burns T, Rugkåsa J, Molodynski A, Dawson J, Yeeles K, Vazquez-Montes M, et al. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. Lancet 2013;381:1627–33,16 with permission from Elsevier.

FIGURE 8.

Duration of admissions in months. Reproduced from Burns T, Rugkåsa J, Molodynski A, Dawson J, Yeeles K, Vazquez-Montes M, et al. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. Lancet 2013;381:1627–33,16 with permission from Elsevier.

We conducted a per-protocol sensitivity analysis for the primary and secondary outcomes, removing the 91 protocol violations (i.e. excluding those patients who were discharged to the wrong arm of the trial or were not discharged, and the three ineligible or withdrawn patients, for whom we had no data on the primary outcome). This analysis was based on 245 cases with no protocol violations. It did not alter the findings (Table 7).

Table 8 shows details of the treatment process (days in the community under the randomised legal compulsion, days under any legal compulsion during the follow-up period, and the number of contacts with the service per month). The number of days spent in the community after hospital discharge under the randomised compulsory outpatient supervision (i.e. randomised compulsion) was substantially longer in the CTO group (median: 183 days compared with 8 days for the non-CTO group) and this was highly statistically significant. The time to first voluntary status was also substantially longer for the CTO group (Figure 9). Overall, the total number of days under any compulsion during the 12-month follow-up period was significantly greater in the CTO group (median: 255 days) than in the non-CTO group (102 days), which was again highly statistically significant (p < 0.0001). This total number of days included compulsion under the randomised regime (either CTO or non-CTO), any time on CTOs for crossover patients in the non-CTO group and any time as a compulsory inpatient or on a subsequent CTO. The self-reported number of contacts with the service per month during the time outside hospital did not differ between the two groups (with a median of two contacts reported in each group) (see Table 8).

FIGURE 9.

Time to first voluntary status. Reproduced from Burns T, Rugkåsa J, Molodynski A, Dawson J, Yeeles K, Vazquez-Montes M, et al. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. Lancet 2013;381:1627–33,16 with permission from Elsevier.

Table 9 shows the number of nights spent in psychiatric hospital during the 12-month follow-up period for the whole sample and for those patients who were readmitted. For the whole sample, the number of nights in hospital from randomisation (index) to 12 months did not differ significantly between the two groups [incident rate for CTO group 0.9 times the incident rate for the non-CTO group (95% CI 0.65 to 1.26; p = 0.550; not tabulated]. When patients who were never discharged were excluded from this analysis, the difference remained non-significant. The time from randomisation to discharge from hospital was similar between groups [median 8 days in the CTO group vs. 16 days in the non-CTO group, HR 1.08 (95% CI 0.86 to 1.34); not tabulated; Figure 10]. For those 119 patients who were readmitted only, the number of nights in hospital from randomisation to 12 months did not differ between the CTO and non-CTO groups and nor did the number of nights from randomisation to first discharge from hospital or the number of nights from the first readmission to the end of the follow-up period (whether or not excluding those who were never discharged) (see Table 9).

FIGURE 10.

Time to first discharge (n = 333). Reproduced from Burns T, Rugkåsa J, Molodynski A, Dawson J, Yeeles K, Vazquez-Montes M, et al. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. Lancet 2013;381:1627–33,16 with permission from Elsevier.

Tertiary outcomes

Table 10 presents the clinical and social factors for the whole sample at baseline and 12 months, along with the estimated average change over time. Table 11 presents the same clinical and social factors at 12 months for the CTO and non-CTO groups, along with the test statistics for the difference in change over time between the two groups.

There were some statistically significant changes over the 12 months in the total sample of 333 (see Table 10). Patients reported higher effectiveness of treatment pressure (Index of Effectiveness, average change 2.10 points, 95% CI 1.32 to 2.89 points; p < 0.001) and more positive views of the fairness of the pressure applied (Index of Fairness, average change 1.31 points, 95% CI 0.54 to 2.08 points; p = 0.001). They also reported more positive relationships with clinicians at 12 months compared with baseline (STAR-P, average change 2.97 points, 95% CI 0.97 to 4.97 points; p = 0.004). This included more positive collaboration (average change: 1.81 points, 95% CI 0.71 to 2.93 points; p = 0.001) and less non-supportive clinician input (average change: 0.66 points, 95% CI 0.06 to 1.25 points; p = 0.031). Although the sample expressed a desire for gaining control in decision-making and to be given information about their illness, the scores were lower at 12 months than at baseline (Decision Making Preference, average change –4.83 points, 95% CI –8.24 to –1.41 points; p = 0.006 – Information Seeking Preference, average change –3.94 points, 95% CI –6.98 to –0.90; p = 0.011). There was an increase over time in patients scoring positively for potential problem drinking [odds ratio (OR) 5.01, 95% CI 1.31 to 19.19; p = 0.019]. Attitudes to medication were more positive across the sample (DAI-10, average change 1.74 points, 95% CI 0.57 to 2.91 points; p = 0.004) and more patients were in employment at 12 months (2.74 points, 95% CI 0.99 to 4.48 points; p = 0.002). Significantly fewer patients were prescribed clozapine (OR 0.13, 95% CI 0.03 to 0.63; p = 0.011) and depot medication (OR 0.09, 95% CI 0.03 to 0.24; p < 0.001) at 12 months compared with baseline.

There were no significant differences between the two arms in the change from baseline to 12 months in any of the reported outcomes except for the Index of Effectiveness (see Table 11). Those in the CTO group showed a smaller increase over time than those in the non-CTO group in their agreement that the treatment pressure they had experienced had been helpful. The difference was small (–1.22 points, 95% CI –2.32 to –0.14; p = 0.028).

The sensitivity analysis using multiple imputation did not alter the outcome results.

Subgroup analyses

The observed values for the primary outcome (psychiatric hospital readmission) and main secondary outcomes (nights in hospital and days to first readmission) in the subgroup analysis are shown in Table 12, and for the main clinical outcomes (BPRS and GAF) in Table 13. Adjusted values for the statistically significant interactions (adjusted for the randomisation factors) are presented in the text.

There were no statistically significant interactions between any of the subgroups and the primary outcome measure of readmission or for time to first readmission, duration of readmissions or social functioning.

Severity of symptoms (BPRS) demonstrated crossover interactions with age in the two arms (interaction coefficient –4.49; p = 0.043). In the CTO group, those aged < 40 years had more severe symptoms than those aged > 40 years [39.54 (95% CI 37.55 to 41.52) vs. 37.96 (95% CI 35.58 to 40.34)]. Among the non-CTO group, those aged < 40 years had less severe symptoms than the older group [38.64 (95% CI 36.53 to 40.75) vs. 41.56 (95% CI 39.35 to 43.78)].

There were also crossover interactions between symptoms and subgroups with and without some tertiary education (interaction coefficient = –5.62; p = 0.024). In the CTO group, those without tertiary education had more severe symptoms than those with tertiary education [40.05 (95% CI 38.35 to 41.76) vs. 34.92 (95% CI 31.78 to 38.07)]. Among the non-CTO group, those without tertiary education had less severe symptoms than those with tertiary education [39.93 (95% CI 38.13 to 41.73) vs. 40.42 (95% CI 37.62 to 43.22)].

The proportion of patients on depot medication at baseline was not statistically different between the two groups [85/166 (51%) in the CTO arm vs. 103/167 (62%) in the non-CTO arm; p = 0.054). The statistically significant reduction in the number of patients prescribed depot medication over time was unexpected. Our exploratory analyses showed that the reduction was significant in both groups (OR 0.04, 95% CI 0.01 to 0.11; p < 0.001) and that it was significantly larger in the CTO group than among the non-CTO group (OR 6.08, 95% CI 1.48 to 24.97; p = 0.012). There was no statistically significant difference in the primary outcome measure of readmission between those on depot and those not. There was also no interaction effect of the CTO and non-CTO groups with being prescribed depot (interaction coefficient 0.85; p = 0.586).

Deaths

Five patients died during follow-up: two deaths by suicide and one by accidental death from a drug overdose were recorded in the CTO group, and one death by suicide and one death from natural causes were recorded in the non-CTO group. The DMC did not regard these deaths as necessitating the ending of the trial.

Study population

Of the 336 randomised patients in the OCTET Trial, three were excluded and five died during the follow-up period (see Chapter 6, Results). In order to reduce the potential bias in the cost-effectiveness results due to the imbalanced timing of deaths, we removed these eight patients from the Economic Evaluation, which was therefore based on 328 patients. Table 14 shows the sociodemographic and clinical characteristics of these 328 patients (CTO 163; non-CTO 165).

Data collection

We collected all outcome and resource-use data through face-to-face interviews with the trial patients at baseline and at 6 and 12 months. We based the cost analysis on an amended version of the CSRI instrument,116 a widely used and well-validated instrument for collection of resource-use data in mental health. Collected data included all hospital and community health and social services, psychotropic medication, productivity losses and informal care. Information on manager hearings and tribunals were extracted from the trial clinical research forms.

Outcomes

The primary economic analysis was a cost–utility analysis, for which the quality-adjusted life-year (QALY) calculated using the EuroQol-5 Dimensions, three-level version (EQ-5D-3L) was adopted as the effectiveness measure. 119 The EQ-5D-3L is a standardised, non-disease-specific instrument used for describing and valuing health-related quality of life. 120 It is widely used in health economics and it is the preferred measure by the National Institute for Health and Care Excellence (NICE). 121 We valued EQ-5D-3L responses using the UK ‘tariff’ of utility values for discrete health states, and expressed changes in terms of QALYs gained over 12 months in comparison to the relevant baseline values. 122 Quality of life was assumed to change linearly between health states. We also compared the changes between baseline and 12 months on the EQ-5D visual analogue scale (EQ-5D VAS), in which patients rate their overall health status on a visual analogue scale (range 0–100). We carried out a secondary economic analysis using the newly developed multidimensional capabilities instrument, the Oxford Capabilities Questionnaire – Mental Health (OxCAP-MH) (Table 15) and the resulting 16-question capability index (CAPINDEX16) as outcome measures. The development of this measure is described later in the report (see Chapter 10).

Costs

We applied national-level unit costs to each resource-use item to calculate the total cost of resources used by each patient (Tables 16–18). All unit costs were for the financial year 2012–13 and were expressed in British Pounds (£). We calculated medication costs using daily dose data and multiplying this with the average unit price for each compound based on the British National Formulary. 123 We estimated lost productivity costs using the human capital approach. We multiplied days off work by the average daily UK national salary for patients who were employed or self-employed. 124,125 We estimated informal care costs by multiplying the average UK hourly salary for 2012–13 by the number of hours family and friends spent on helping patients because of their illness.

Analyses

Although we primarily assessed cost-effectiveness from the health and social care perspective preferred by NICE,121 we thus also conducted separate analyses including indirect costs such as lost productivity and informal care. We assessed independently the impact of CTOs on the number of manager hearings and tribunals. We also investigated the impact of missing data in contrast with the complete cases data set in our sensitivity analysis. For this, we assumed missing data to be missing at random, and estimated values using multiple imputation with randomisation group, age, gender, main clinical diagnosis, illness duration and length of inpatient stay as covariates. 133 The number of imputations sets was kept at 30 for costs and EQ-5D, and 50 for the OxCAP-MH index (CAPINDEX16), driven by the percentage of cases that were incomplete. 134 Further sensitivity analyses addressed the potential impact of the assumed pattern of transition between health states on the outcome results.

Results are reported as means with standard deviations (SDs) or as mean differences with 95% CIs. We compared differences in mean costs and effects in a regression framework, with a p-value of < 5% considered as statistically significant. We used non-parametric bootstrapping135 from the cost and effectiveness data to generate a joint distribution of the mean incremental costs and effects for the options under comparison and to calculate the 95% CIs of the incremental cost-effectiveness ratio (ICER). We represented uncertainty around the main cost-effectiveness estimates by cost-effectiveness acceptability curves (CEACs) using the net benefit approach. 136,137 CEACs show the probability that each option is cost-effective to a range of maximum values (ceiling ratio) that a decision-maker might be willing to pay for an additional unit of improvement in outcomes. We carried out all analyses according to the intention-to-treat principle, using Microsoft Excel^® 2010 (Microsoft Corporation, Redmond, WA, USA) and Stata 13 software.

Outcomes

Table 19 shows the mean value of the different outcome measures (EQ-5D-3L, EQ-5D VAS and OxCAP-MH index) at baseline and at 6 and 12 months. There was no significant difference in the change in QALYs gained during the 12 months in comparison with baseline between the CTO and non-CTO groups (Table 20). Neither could we find an indication of benefit for CTO in comparison with non-CTO in terms of patients’ capabilities either in the complete case analysis (n = 67, mean OxCAP-MH index difference: 0.818, 95% CI –2.04 to 3.68; p = 0.58) or in the full imputed data set (n = 328, mean OxCAP-MH index difference: 0.527, 95% CI –0.62 to 1.68; p = 0.37).

Costs

The mean costs per patient over the 12-month follow-up are listed according to the different resource-use categories and analysis scenarios in Table 21. Further discussion of the main cost results are based on the full imputed data set. The mean total health and social care costs were £35,959 per patient (SD £44,886) in the CTO group and £36,003 per patient (SD £41,406) in the non-CTO group. The costs of mental health hospitalisation accounted for > 85% of the annual health and social care costs. There was no indication of a significant difference between the groups in any of the investigated health and social care cost categories, either in the complete case or in the full imputed data set analyses.

Only one patient in the CTO group and five patients in the non-CTO group had any period of employment or self-employment during the 12-month follow-up period, and from these only one reported lost productivity due to sick leave. Patients in the CTO group had significantly higher mean informal care costs than patients in the non-CTO group: £6138 versus £2993, respectively (see Table 21). The mean number of manager hearings and tribunals per patient was also significantly higher in the CTO group, as would be expected (Table 22).

Cost-effectiveness

In the complete case analysis, the non-significant differences in mean costs (health and social care perspective £5388, societal perspective £7067) and mean effects (0.003 QALY gained) between the CTO and the non-CTO groups resulted in ICERs of £1,893,388/QALY gained from the health and social care perspective and £2,483,349/QALY gained from the societal perspective. After conducting multiple imputation of missing data, we found non-significant mean cost differences of –£44 from the health and social care perspective and £3102 from the societal perspective between the CTO and non-CTO groups. The mean effects difference (0.006 QALY gained) was also non-significant resulting in ICER point estimates of –£7651/QALY gained (health and social care perspective) and £537,292/QALY gained (societal perspective), respectively.

Figure 11 illustrates the uncertainty around the ICER point estimates using scatterplots of the bootstrapped cost and effectiveness pairs for CTO compared with non-CTO for the different analysis scenarios. The points in the scatterplot fall in all four quadrants of the cost-effectiveness plane, suggesting that there is no unequivocal conclusion to be drawn regarding the cost-effectiveness of CTO in terms of QALYs gained. Figure 12 shows the relevant statistical uncertainty in the form of CEACs. These clearly illustrate that, independently of the analysis scenario, the probability of CTO being cost-effective remains at ≤ 50% or below at the currently considered maximum UK cost-effectiveness threshold value of £30,000/QALY. 121

FIGURE 11.

Bootstrapped mean differences in costs and effects of CTO vs. non-CTO. (a) Health and social care costs, complete case analysis (n = 121); (b) health and social care costs, imputed full data set (n = 328); (c) societal costs and effects, complete case analysis (n = 102); and (d) societal costs and effects, imputed full data set (n = 328).

FIGURE 12.

Cost-effectiveness acceptability curves. (a) Health and social care costs, complete case analysis (n = 121); (b) health and social care costs, imputed full data set (n = 328); (c) societal costs, complete case analysis (n = 102); and (d) societal costs, imputed full data set (n = 328).

The assumed pattern of transition between health states had no impact on the final results and conclusions. The mean QALY difference was –0.008 (95% CI –0.10 to 0.08; p = 0.87) between CTO and non-CTO when transition was assumed at the beginning of the time period, and 0.017 (95% CI –0.03 to 0.07; p = 0.49) when transition was assumed at the end of the time period.

Design

Individual in-depth interviews provide rich data on personal experience and are particularly appropriate for studying sensitive research topics. We conducted interviews with patients (AS), family carers (JR) and psychiatrists (KC), respectively. We initially invited participants to tell their story freely and then used a semistructured topic guide to ensure that the same topics were covered in each interview (allowing for within- and between-case comparisons). The topic guide was developed in co-operation with service user and carer representatives. (It is available from the authors by request.) The interviewers were Anna Sulman (AS, social science graduate, white British female, early thirties), Jorun Rugkåsa (JR, PhD in sociology, white Norwegian, early forties) and Krysia Canvin (KR, PhD in Law, white British, late thirties).

The interviews with each subsample used a specifically designed topic guide containing open-ended questions in order to spark discussion of specific topics, followed by open, participant-driven elaboration. We developed the topic guide from emerging findings in the OCTET Trial and from the literature, and piloted it to ensure its acceptability to participants. Topics included experiences of and views about:

• mental health services (views on compulsion and, in particular, its use in mental health care)

• CTOs and Section 17 Leave and how they work

• other types of coercion and how they work.

Interviewers prompted participants about CTO conditions and recall. We probed for nuance, including changes over time and circumstances, and differences between CTOs and other inpatient and outpatient interventions. We also asked family carers questions regarding their views and experience of informal coercion in general and of leverage in particular. We asked psychiatrists about the ethical challenges of working with CTOs and Section 17 Leave. We offered patients and family carers £25 as a compensation for their time. After the interview, we gave participants the opportunity to review their transcript before providing consent for the use of direct quotations. We audio-taped all interviews and transcribed them ad verbatim. A researcher checked the transcripts for accuracy and returned them to the participant if the participant had indicated that they wished to review it. If a participant did not want a particular section quoted, this was marked in the transcript. Atlas.ti qualitative analysis software version 6.2. (Scientific Software Development, Berlin) aided the storage, management and retrieval of data.

Sampling and data collection

Sampling was purposive and aimed to achieve maximum variation139 of characteristics that were expected to influence views, experiences and use of CTOs. The sampling pool for patient interviews comprised the 237 patients (119 CTO, 118 non-CTO) from the OCTET Trial sample who had agreed to be approached about the Qualitative Study (93 declined, 3 were deceased). As we were primarily interested in personal experiences of being under a CTO, we aimed to sample 75% of interviewees from the CTO arm. We recruited psychiatrists from the pool of those with whom we had discussed recruitment to the trial. This included psychiatrists from both inpatient and outpatient settings and psychiatrists who did and did not recruit to the trial. We recruited family carers via carer organisations, research collaborators and via snowballing.

Analysis

We utilised a modified version of Grounded Theory,140 an inductive methodology concerned with producing theoretical and conceptual insights grounded in empirical data. Following initial line-by-line ‘open’ coding of the transcripts,141 we identified patterns and deviant cases using the constant comparative method. 142 Coding and initial analyses were undertaken while the relevant researcher was blind to the OCTET Trial results.

When conducting qualitative analysis, as we elaborate in more detail in relation to the ULTIMA Qualitative Study (see Part 4, Chapter 19), researchers usually decide a posteriori which analytical strands to pursue and in what order. Given the aim of the overall programme, we decided first to pursue analysis of participants’ experience of the mechanisms by which CTOs were designed to work (conditions and recall) and their impression of how they worked.

The four themes discussed below originated from different aspects of the Grounded Theory analytical approach used. Taking a deductive approach, we specifically asked about and coded for participants’ experiences and views of CTO recall and conditions. An inductive analytical approach led to the emergence of the notion of legal clout. We also sought data on participants’ considerations about the effectiveness of CTOs, as this was part of the overall agenda for the OCTET Study. Rather than using a preconceived definition of effectiveness, here we used participants’ descriptions compared against their perceptions of the purpose of CTOs, combining the deductive and inductive approaches. We conducted focused coding141 in order to identify and analyse all mentions of these themes. All members of the qualitative research team provided input into the analysis through regular discussion of the findings and their interpretation.

We also examined the interview transcripts closely to identify ethical issues arising (as reported separately; see Chapter 9).

Sample

Of the 45 patients with whom we made contact, three in the CTO arm of the RCT and one in the non-CTO arm declined to participate. Two CTO patients and two non-CTO patients cancelled their interviews. None of the 25 psychiatrists approached declined to participate. A total of 26 family carers volunteered and were interviewed. Participants were geographically spread across England and attached to a range of mental health teams, including Early Intervention Services (EIS), CMHTs, AOTs and forensic teams, and together they had experience of the various aspects of CTOs. Interviews lasted on average 65 minutes (range 25–135 minutes). The sample is described in Table 23.

The topic of the analysis reported here was the experience of CTOs, so this did not include patients in the non-CTO arm. Two family carers were also excluded as the person they cared for had not been on a CTO. We therefore report from interviews with samples of the 26 patients with CTO experience, 24 family carers and 25 psychiatrists.

Quotations from the transcripts are included to illustrate and validate our interpretations. 143 Words and short phrases appearing in the text in quotation marks are examples of the language used by participants. Words appearing in italics indicate descriptive analytical labels reflecting themes. Quotations are attributed to patients identified by a unique patient identification (ID) number, team and CTO status (e.g. ‘CTO ongoing’); family carers identified by a unique carer ID number and relationship to the patient; and professionals identified by profession, unique ID number and type of service. When this is a dialogue with the interviewer, speakers are identified in full, where first mentioned, and by P (patient), C (carer) or I (interviewer) subsequently.

Views and experiences of community treatment order conditions

As described above (see Part 2, Chapter 5), the CTO regime in England and Wales specifies two mandatory conditions that apply to all CTOs:48 first, patients who refuse medication or who lack capacity must be assessed by a second opinion appointed doctor (SOAD) to confirm that the treatment specified is appropriate; and second, all patients must make themselves available for assessment for renewal of the CTO. The RC and AMHP who initiate the CTO may also specify discretionary conditions based on their knowledge of an individual patient. We asked psychiatrists, patients and family carers about their experience of CTO conditions.

Views and experiences of recall to hospital under the community treatment order

Under a CTO, a patient may be recalled to hospital when the patient (1) requires treatment in hospital and in the absence of recall there would be a risk of harm to self or others, or (2) does not comply with one of the mandatory conditions. As described above, the Code of Practice states that patients and their families should be consulted about the CTO, its conditions and the need to recall. 48 We asked psychiatrists, patients and family carers about their experience of recall.

Influence of legal clout

All three groups referred to respect for the legal powers of the CTO and those administering them and how this influenced patients’ behaviour: we refer to this as legal clout.

Impressions of community treatment orders’ effectiveness

All three groups expressed the idea that the desired effects of CTO would be adherence and avoiding hospitalisation. The extent to which they thought this was achieved in practice varied within and between the groups.

Patient benefit

A number of participants talked about the benefits that they perceived to accrue from a patient being placed on a CTO.

Some family carers stressed the speed of response that could be instigated under a CTO as supporting positive outcomes for the patient, even if that patient was recalled to hospital:

Chiefly it’s the speed with which he’s dealt with which prevents all this deterioration and building up of bills and filth and ends up in criminal behaviour. I mean that is all saved ‘cos they take him in as soon as he stops co-operating.

Carer 2, parent

This was a view endorsed by some psychiatrists who saw benefits accruing to a patient when recall took place, minimising the decline in a patient’s distress and reducing the time required in hospital:

Their difficulty with this man is what to do when he becomes unwell because he just starts moving so fast that organising a Mental Health Act assessment, the logistics of getting two doctors and an AMHP and him and the police all in one place is so difficult that there’s a delay of some days before, between the time they decide he has to come back and where they actually can go through the mechanics of getting him in . . . And during that delay there is a lot of risk to himself, he deteriorates and that probably costs him some weeks in hospital later on and [the AMHP] said actually if we could just recall him then it would be much better.

Consultant psychiatrist 8, inpatient

Some patients also perceived that they were able to get appropriate treatment more quickly under a CTO than was possible as a voluntary outpatient, and regarded this as a positive outcome:

That is another important point, when I get ill and I’m under the [CTO], I get admitted to hospital quicker than when I’m alone like now, so I save time and I catch up with my illness straightaway and quickly. With myself, not under the [CTO], I will have to see a doctor then the doctor will see another doctor and then they will decide to get me into the hospital and then they will send the police. That procedure, nobody likes that procedure.

Patient 3, CMHT, CTO ended

These patients emphasised the possibility that CTOs could provide a ‘window of opportunity’ to maintain their stability in the longer term by allowing them to establish a new collaborative relationship with the community team. Two psychiatrists suggested that CTOs could improve patients’ engagement with services because of the requirement for the patient to agree to the original care plan set in place to govern the use of the CTO. When the CTO was perceived to make longer-term stability possible, the legal regime of care management under a CTO was seen as crucial for patients:

The thing is when I was unwell I’d function and I’d do the groceries and make the dinner and stuff but I’d be drinking and making up all this stuff in my head and I’m not doing that now. I’m well and I’m stable but I think CTO just because it is threat, threat is the wrong word but it’s the safeguard, it’s the safeguard that if I was to think of going on a bender I just wouldn’t because I wouldn’t want to jeopardise all this work that I’ve put into being well again.

Patient 10, CMHT, CTO ongoing

Although this patient identified that the safeguards associated with her CTO had led to increased stability, other psychiatrists, patients and family carers expressed concerns that patients were no better off under a CTO. Some highlighted a difficulty in accessing treatment as a particular concern:

The point is a CTO, the most important thing is that they can access treatment, and I don’t think – well [patient’s name] definitely couldn’t access the treatment. The following weekend which was the . . . cos there’s no out of hours service. After 5 o’clock that’s it. And the home treatment team you almost have to book them.

Carer 9, parent

A second concern expressed was that the process of placing a patient on a CTO could ossify care planning, preventing an individual’s broader needs being met and undermining a dynamic process of reviewing changes in the services required:

My disappointment with the community treatment order is that . . . it keeps [patient’s name] quiet. It keeps him very under the weather. I feel in a way that it – if only the community treatment order was not just a medical model . . . if there was a social side going along with it then it would be useful, but I think it just simply holds a situation. OK [patient’s name] doesn’t become psychotic because of the medication and I know he’d get taken in very quickly if he did stop medicating but it doesn’t do anything for recovery or a plan forward. I think it simply contains him, here.

Carer 13, parent

Patient autonomy

Although previous ethical analyses have emphasised that imposing a CTO on a patient who has the capacity to refuse treatment fails to respect patients’ autonomy, the restriction of choice in the act of being placed on a CTO was specifically mentioned as a concern by only about half of the patients whom we interviewed. Otherwise, the patients focused their attention on the positive and negative impacts of CTOs on their self-identity and their ability to modify their life plans in order to act in line with their own values.

One view expressed was that the clarity of knowing how a service would respond if patients were to act in certain ways was important for these patients, and that this opportunity was not available to them when on short-term leave from hospital:

I suppose potentially I think CTOs could be seen as being the better of the two from the patient’s perspective because at least the conditions are clear and sort of it’s not, whereas in Section 17 Leave it can you know, it can just be used completely in a coercive way because you’re not really sort of setting out what you want, you’re saying, you’re still under the section.

Consultant psychiatrist 14, CMHT

This insight was seen as important to patients as well, not just because of the benefit that accrued from understanding where they stood, but in that it provided a route back to a normal life:

I feel very, very well, very confident to take steps back to a normal life. I go and see my kids every time – I am separated from the mother who lives in the same house as them, but I visit them like anytime, it’s open. I am searching for a job at the moment, I claimed – what is it called – I applied for chances with volunteer organisations, I filled the forms and gave it to them, just to fill my time and to give me the idea of the work environment and having people around you and stuff and getting used to normal people and things.

Patient 3, CMHT, CTO ended

Again, this suggests that instigating a new legal regime provided a ‘window of opportunity’ for the patient to evaluate what was of importance to them, and to take active steps to achieve these goals. Interestingly, one patient accounted for this transition in terms of how a legal regime – in which he was expected to fulfil certain tasks directly associated with his illness – freed him from the constraints that he had placed on himself:

I’m not under pressure. I’m an entirely free agent. I’ve got a little area on top of my writing bureau; I’ve got all my things set out and I know what time, exactly what time I take [medication] and the quantity, how many and yeah I’ve got a little – it’s like a little altar it is to my medication and these little pots.

Patient 32, forensic, CTO ongoing

For other patients, however, CTOs were viewed as infantilising, placing them under a regime of supervision that held them back from pursuing options in their lives, rather than enabling them to pursue valuable activities. The following patient illustrated this by commenting on his experiences having been discharged from a CTO:

I feel that I’m a free man again you know. I don’t need to tell, to let them know of everything I want to do. I’ve got a bit of privacy. I’m a grown man and I should be able to look after myself.

Patient 2, CMHT, CTO ended

From the perspective of many family carers, a CTO was viewed as containment: a way of managing the patient in the community that was not associated with the requisite supports that the patient needed to become independent and to act autonomously in their lives:

It would be a lot better if the team were active and found something for this intelligent man to do. You know he just sits doing crosswords from the newspaper and that’s about it now. You know, he’s becoming more and more isolated and more and more withdrawn. I think the CTOs just contain him.

Carer 13, parent

The lack of support that accompanied a CTO was also mentioned by one patient, who equated the imposition of this legal power with the limited opportunities he felt he had to embark on a range of activities:

You know it’s imprisoning them, it’s imprisoning them in a system that can only just maintain some sort of degree of normality you know. They think they can preserve some degree of normality whereas people can if given the opportunity of being allowed off of a CTO for 6 months . . .

Patient 17, CMHT, CTO ended

There was qualified support for CTOs in view of the obligation to promote a patient’s autonomy, even if it is correct to observe that the original decision to place a competent patient on a CTO fails to respect that patient’s autonomy. It is again important, however, to note that the majority of the accounts of patients’ abilities to act autonomously within the community setting hinged on whether or not appropriate personal and social support was provided within the mental health service, rather than being determined by the use of the legal power itself. It is only for those small numbers of patients who viewed the legal regime of the CTO as liberating them from the difficulties of managing their illness to focus on other life goals that mandated community treatment looked to be justified from the standpoint of autonomy.

Patient liberty

Given that clinicians are able to determine the specific content of the discretionary conditions of the order, it is unsurprising that the impact that CTOs can have on patients’ liberty was identified as an ethical concern. It is also clear, however, that CTOs are less liberty restricting than the use of compulsory powers of detention and treatment within inpatient settings. This position was endorsed widely by psychiatrists, patients and family carers, who all recognised that patients’ freedoms were better protected by CTOs when contrasted with inpatient care.

The interview data yielded several insights into how patients experienced freedom under a CTO compared with their experiences of outpatient care more generally. Perhaps surprisingly, the CTO regime was seen by a number of patients as being no more restrictive than being a voluntary outpatient. This observation was explained in terms of the ways in which patients and carers saw community services supporting those with severe and enduring mental disorders. Three patients expressed concerns that, as people eligible to receive mental health services, their freedoms were constantly at risk on the grounds that they were caught up in a system that demanded compliance from them. Although, in legal terms, patients enjoyed greater freedoms when not subject to such powers, the same patients identified that they could not easily differentiate between the restrictions imposed by the CTO and their experiences of being treated as voluntary outpatients. This is illustrated by the following patient’s account of rehospitalisation:

I mean I just want to be free from the mental health services and get on with my life. Go to college and I’m able to do that but I feel like I’m not being allowed to because all it takes is for you to go unwell once like with drugs and be taken to hospital and then they’re all talking about, oh he’s got schizophrenia again . . .

Patient 1, CMHT, CTO ongoing

Importantly, however, the implications of such experiences for ethical considerations of liberty need to be reviewed carefully. Although this patient might feel that her liberty is being restricted when receiving community mental health care, it is incorrect that her liberty is restricted – as a matter of fact – when she is not subject to legal powers in the community (although, of course, how she exercises her freedom might lead to the imposition of legal powers in the future). The concerns she raises are better viewed in terms of the other ethical considerations identified above, such as personal autonomy. Here, her autonomy might fail to be respected within a service that does not support the person to pursue her own life choices adequately, quite independently of whether or not that patient is being treated under a CTO.

Methods

The OxCAP-MH was utilised in interviews with the cohort of patients in the OCTET Trial at each time point, in order to test its feasibility and validity for this patient group. The final list of functioning/well-being-related outcome measures used in the OCTET Trial included the GAF scale101 and the EQ-5D-3L120 as well as the OxCAP-MH. This enabled us to test the construct validity of the OxCAP-MH. The reliability of the CAPINDEX16 was tested using Cronbach’s alpha. Factor analysis was performed in order to confirm the scoring of the CAPINDEX16 (details from the authors on request). The effects of age, gender, illness duration and primary clinical diagnosis, and the association between the EQ-5D-3L, the GAF and the OxCAP-MH items, were investigated using multiple regression analyses. Statistical significance was investigated at a two-sided p < 0.05 level. All data analyses were carried out using Stata 11.

Results

OxCAP-MH capability domains

Figures 13 and 14 show the distribution of capability levels across the 18 capability domains of the OxCAP-MH, with lower-level responses indicating more limitations in the given capability dimension. The vast majority (246, 88%) answered ‘No’ to the ‘Property ownership’ domain. A smaller majority (145, 56%) reported some level of limitations in carrying out their ‘Daily activities’ because of health problems. Over 30% of the sample also reported very severe or severe limitations (level 1 or 2 answers on a 1–5 scale) in their capabilities to ‘Influence local decisions’ (109, 48%), to ‘Enjoy recreation’ (83, 32%) or in ‘Planning one’s life’ (71, 31%). One-third (80, 33%) reported having a very high or high likelihood of experiencing ‘Discrimination’ and just over one-third (83, 37%) reported a subjective ‘Life expectancy’ that was lower than that of the general population.

FIGURE 13.

Capability domain scores (two- and three-level answers). Reproduced from Simon J, Anand P, Gray A, Rugkåsa J, Yeeles K, Burns T. Operationalising the capability approach for outcome measurement in mental health research. Soc Sci Med 2013;98:187–96,144 with permission from Elsevier. LE, life expectancy.

FIGURE 14.

Capability domain scores (five-level answers). Reproduced from Simon J, Anand P, Gray A, Rugkåsa J, Yeeles K, Burns T. Operationalising the capability approach for outcome measurement in mental health research. Soc Sci Med 2013;98:187–96,144 with permission from Elsevier.

Female patients scored lower than male patients, on average, on most capability domains except for ‘Property ownership’, ‘Access to interesting forms of activities’, ‘Influence local decisions’ and enjoying the ‘Love and support’ of family and friends (Figure 15). The limiting effects of female gender proved statistically significant for the ‘Suitable accommodation’, ‘Neighbourhood safety’ and ‘Life expectancy’ domains, and resulted in greater ‘Potential for assault’ (Table 27).

FIGURE 15.

Mean capability levels by gender: 1, very severe limitations, 5 = no limitation. Reproduced from Simon J, Anand P, Gray A, Rugkåsa J, Yeeles K, Burns T. Operationalising the capability approach for outcome measurement in mental health research. Soc Sci Med 2013;98:187–96,144 with permission from Elsevier.

TABLE 27 - Multiple effects of age, gender, primary clinical diagnosis of other psychosis diagnoses (including bipolar disorder) and illness duration on individual capability domains

Ordered logit regression.

This table has been reproduced from Simon J, Anand P, Gray A, Rugkåsa J, Yeeles K, Burns T. Operationalising the capability approach for outcome measurement in mental health research. Soc Sci Med 2013;98:187–96,144 with permission from Elsevier.

Capability domainsa	Sample size	Age (years)		Female gender		Other psychosis diagnoses (including bipolar disorder		Illness duration (years)
		Coefficient	p-value	Coefficient	p-value	Coefficient	p-value	Coefficient	p-value
Life expectancy	221	0.030	0.063	–0.814	0.006	0.172	0.654	–0.037	0.035
Daily activities	254	–0.000	0.993	–0.514	0.093	0.291	0.463	–0.053	0.006
Suitable accommodation	263	0.028	0.061	–0.503	0.050	–0.048	0.887	–0.012	0.442
Neighbourhood safety	264	0.041	0.008	–0.689	0.007	–0.276	0.414	–0.038	0.020
Potential for assault	238	0.044	0.006	–0.950	0.001	0.495	0.174	–0.056	0.001
Freedom of expression	226	0.006	0.757	–0.138	0.640	0.937	0.021	–0.029	0.128
Imagination and creativity	225	0.014	0.448	–0.114	0.703	1.236	0.002	–0.037	0.062
Access	223	–0.010	0.547	0.135	0.642	1.251	0.002	–0.004	0.843
Love and support	283	0.009	0.534	–0.018	0.942	0.748	0.028	–0.004	0.792
Losing sleep	252	–0.017	0.267	–0.266	0.313	–0.333	0.311	0.001	0.949
Planning one’s life	224	0.009	0.595	–0.145	0.605	0.381	0.295	–0.022	0.222
Respect and appreciation	223	0.016	0.370	–0.314	0.310	0.546	0.166	–0.026	0.187
Social networks	294	–0.024	0.255	0.051	0.886	0.182	0.696	–0.021	0.330
Discrimination	243	0.026	0.094	–0.315	0.238	–0.046	0.895	–0.031	0.071
Appreciate nature	224	0.005	0.801	–0.195	0.511	0.929	0.016	–0.023	0.232
Enjoy recreation	252	–0.002	0.910	–0.128	0.621	0.433	0.188	0.010	0.506
Influence local decisions	224	–0.040	0.021	0.279	0.327	0.096	0.791	0.025	0.182
Property ownership	276	0.069	0.002	0.132	0.735	–0.127	0.805	–0.025	0.247

Patients with a primary clinical diagnosis of schizophrenia reported lower mean scores than those with other psychosis diagnoses (including bipolar disorder) for 11 of the OxCAP-MH domains. They reported the same mean score for the ‘Suitable accommodation’ domain and somewhat higher mean scores for the remaining six capability domains: ‘Social networks’, ‘Influence local decisions’, ‘Daily activities’, ‘Discrimination’, ‘Losing sleep’ and ‘Neighbourhood safety’ (Figure 16). The greater limiting effects of schizophrenia reached statistical significance for ‘Love and support’ of family and friends, ‘Freedom of expression’, ‘Appreciate nature’, ‘Imagination and creativity’ and ‘Access’ to interesting activities (see Table 27).

FIGURE 16.

Mean capability levels by primary diagnosis: 1, very severe limitations, 5 = no limitation. Reproduced from Simon J, Anand P, Gray A, Rugkåsa J, Yeeles K, Burns T. Operationalising the capability approach for outcome measurement in mental health research. Soc Sci Med 2013;98:187–96,144 with permission from Elsevier.

Higher age had a significant negative effect on the capability to ‘Influence local decisions’, but significant positive effects on ‘Neighbourhood safety’ and ‘Property ownership’, and it was protective against ‘Potential for assault’ (see Table 27). Patients with longer illness duration had significantly more limitations in ‘Neighbourhood safety’, ‘Daily activities’ and ‘Life expectancy’ and had significantly greater ‘Potential for assault’ (see Table 27).

Being less limited in ‘Daily activities’ because of health (β = 0.051; p < 0.01) and not ‘Losing sleep’ over worry (β = 0.058; p < 0.01) were the only individual capability domains that were found to be significantly related to better health-related quality of life measured by the EQ-5D-3L utility scores. Being less limited in ‘Daily activities’ because of health also had a significant positive effect on the EQ-5D VAS (β = 4.793; p < 0.01) and GAF scores (β = 1.274; p < 0.01), similar to ‘Suitable accommodation’ (β = 3.053; p = 0.031) and the ability to enjoy the ‘Love and support’ of family and friends (β = 2.681; p < 0.01), respectively. No other associations between individual capability domains and the EQ-5D VAS and the GAF scores were significant and they are therefore not shown.

Capability index (CAPINDEX16)

The ‘Property ownership’ question had low variability and was eventually deemed irrelevant in the context of mental health. This question and the question on ‘Life expectancy’ were excluded from the overall capability index, which was therefore based on 16 rather than 18 domains. Factor analysis confirmed these decisions. Just over half of the patients (172, 52%) answered all of the other 16 capabilities questions used in the final calculation for the CAPINDEX16. Their characteristics did not differ significantly from those of the full cohort, with a mean age of 38.94 (SD 11.51) years and the majority being male (72%) and having a primary diagnosis of schizophrenia, schizotypal disorders or delusional disorders (89%). A Cronbach’s alpha of 0.79 indicated that the capability index had good internal reliability. The CAPINDEX16 scores ranged from 26 to 75, with a mean of 58.40 (SD 9.32) (Figure 17).

FIGURE 17.

Distribution of the capability index (CAPINDEX16). Reproduced from Simon J, Anand P, Gray A, Rugkåsa J, Yeeles K, Burns T. Operationalising the capability approach for outcome measurement in mental health research. Soc Sci Med 2013;98:187–96,144 with permission from Elsevier.

Female patients and those with a primary clinical diagnosis of schizophrenia or longer illness duration reported significantly lower CAPINDEX16 scores (all p < 0.05) (see Table 26). On average, patients with a diagnosis of schizophrenia had five points lower and female patients had three points lower CAPINDEX16 scores (see Table 26). The correlations between the CAPINDEX16 and the EQ-5D VAS scores, the EQ-5D-3L utility values and the GAF scores were 0.51, 0.42 and 0.25, respectively (Figure 18).

FIGURE 18.

Correlation between the capability index (CAPINDEX16) and other measures of well-being. Reproduced from Simon J, Anand P, Gray A, Rugkåsa J, Yeeles K, Burns T. Operationalising the capability approach for outcome measurement in mental health research. Soc Sci Med 2013;98:187–96,144 with permission from Elsevier.

Uncertainty concerning the choice between regimes

Very similar legal criteria therefore govern the use of the two regimes and there is a strong degree of overlap in the factors to which clinicians are directed and very few mandatory indicators. Some continuing element of hospital-based treatment is required to extend a patient’s Section 17 Leave, but that element of treatment could also be suitable for a patient on a CTO, particularly visits to an outpatient clinic. That requirement therefore does not draw a sharp line between the proper uses of the two schemes. As a consequence, it was highly likely that varying practices would emerge as to the choice between CTOs and Section 17 Leave between different clinicians, hospitals and regions, just as Pinfold et al. 174 found great variation in the implementation of the prior supervised discharge scheme. These variations may simply reflect legitimate professional differences over the proper application of the law.

In these circumstances, some patients could lawfully be allocated to either Section 17 Leave or a CTO. Either decision would be a legitimate exercise of the discretion left in clinicians’ hands by the uncertainties surrounding use of the two schemes. Our research protocol therefore stated that patients might be included in our trial only when their RCs considered that they were proper candidates for involuntary outpatient care and acknowledged uncertainty as to whether to use Section 17 Leave or a CTO. In addition, the protocol stated that patients should not be included in the study if they were viewed as clear candidates for either Section 17 Leave or a CTO, or considered suitable, when leaving hospital, for immediate discharge to voluntary care. To reach those conclusions, the RCs would have to consider the relevant legal criteria, in the Act and the Code of Practice, and still recognise ambivalence between the two options. In that limited situation, it would be lawful, in our view, for RCs to allocate patients at random to one or other regime.

Restrictiveness of the two regimes

The general structure of the two regimes is very similar. The same kinds of conditions can be imposed on compulsory outpatients’ community tenure, similar powers may be exercised by clinicians over outpatients and in neither case is the patient’s consent required to their initial placement under the scheme. Both patients on Section 17 Leave and those on CTOs may be swiftly returned to compulsory hospital care; both have a regular right of access to independent review of their compulsory status before the Tribunal, both must be discharged by their RC or the Tribunal if they cease to meet the relevant criteria, and both are entitled to a second opinion from an approved doctor. In both cases, their involuntary outpatient treatment may be extended repeatedly, if the proper process is followed.

Nevertheless, there are significant differences between the two regimes. The provisions governing Section 17 Leave are more open-textured, so may confer more discretion on clinicians. They also place the authority for decisions more squarely on the shoulders of the RC, instead of requiring prior agreement to be reached between the RC and an AMHP, as is required for many decisions about patients on CTOs. There are differences in the timing of patients’ entitlements to have their position reviewed by the Tribunal and to have their treatment approved by an SOAD. The scope of the treatment powers in the community differs in the two cases, particularly regarding patients who retain their capacity to consent. Moreover, somewhat different legal consequences flow from any recall to hospital of patients treated under the different regimes.

Conditions of outpatient treatment

With regard to the conditions that may be imposed on a patient’s outpatient treatment, and the consequences that may flow from breach of those conditions, the CTO provisions appear somewhat more restrictive than the Section 17 Leave scheme because of the mandatory character of some conditions that must be imposed on treatment under a CTO, and the immediate power conferred to recall patients to hospital for breach of those mandatory conditions. Regarding Section 17 Leave, the Act establishes only very broad parameters concerning the conditions that may be imposed on outpatient care.

Recall may proceed only ‘when it appears to the responsible clinician that it is necessary to do so in the interests of the patient’s health or safety or for the protection of other persons’12 and should proceed only on the basis of an up-to-date medical opinion to meet the procedural requirements of detention for mental health purposes specified by the European Court of Human Rights.

Under the CTO regime, on the other hand, the Act requires certain mandatory conditions to be imposed on outpatient care. Patients on CTOs must make themselves available for medical examination at two key points in the process: when the order’s extension for another term is contemplated and when approval of treatment by the SOAD must occur. Breach of mandatory conditions authorises the patient’s immediate recall to hospital. Optional conditions may be imposed on a CTO that are ‘necessary or appropriate’ to ensure that the patient receives treatment. Agreement on those optional conditions must be reached in advance, however, between the RC and an AMHP: a somewhat more rigorous process than that which is required to set the conditions of Section 17 Leave. The patient cannot be recalled to hospital solely for breach of these optional conditions, but only when ‘(a) the patient requires medical treatment in hospital for his mental condition; and (b) there would be a risk of harm to the health or safety of the patient or to other persons if the patient were not recalled’. 12 Even when the patient is refusing treatment, those standards must be met for recall to occur.

Comparison of the two regimes on these parameters therefore yields very mixed results. A less rigorous process must be followed to set the conditions for Section 17 Leave, but no mandatory conditions are imposed, or is any automatic power conferred to recall patients to hospital simply for breaching the conditions of their Section 17 Leave. Regarding CTOs, on the other hand, a more rigorous process must be followed to set the conditions, but some mandatory conditions are imposed and their breach automatically authorises the use of the recall power. We might therefore say that a CTO is less restrictive of patients’ rights in certain respects (because a more rigorous process must be followed to set the conditions for outpatient care), but more restrictive in other respects (in imposing mandatory conditions linked to an immediate recall power).

Powers to treat without consent

The CTO and Section 17 Leave regimes confer slightly different powers to treat patients under them. The CTO regime distinguishes between the position of patients who have, and patients who lack, the capacity to consent to their community treatment and confers different powers to treat in each case. The Section 17 Leave regime makes no such distinction. It appears to confer a single set of powers to treat outpatients, regardless of their capacity.

Patients on Section 17 Leave remain ‘liable to be detained’. They are thus subject to compulsory treatment. This appears to authorise the administration of medication to patients on Section 17 Leave without their consent, regardless of their capacity, as long as the approval of an SOAD is obtained. The Act, however, confers no express power to administer medication through the use of physical force or restraint in a community setting to a patient on Section 17 Leave and it is doubtful whether or not that would be a safe health practice. Medication may therefore be lawfully administered to patients on Section 17 Leave who are not consenting and not resisting, provided that no significant physical force is used. When physical force is to be used, however, the patient should be recalled to hospital for treatment to proceed (except perhaps in an emergency). The Code of Practice therefore specifies that where treatment without consent of a patient on Section 17 Leave is contemplated, ‘consideration should be given to whether it would be more appropriate to recall the patient to hospital’. 12 Recall permits more extensive assessment of the patient’s condition before and after treatment, although it may also impose additional restrictions on liberty.

Treatment in the community of patients on CTOs distinguishes between patients with and without capacity. 176 Patients on CTOs who retain their capacity cannot be treated in the community without their consent, even in an emergency. To be treated without consent, they must be recalled to hospital premises. Community patients who lack capacity, on the other hand, can generally be treated without consent, even over their objection, provided that no ‘force’ is used.

A clear mechanism is therefore available for treating CTO patients without their consent, regardless of their capacity. Nevertheless, the treatment provisions governing patients on CTOs are more respectful of patients’ wishes than those governing patients who are ‘liable to be detained’.

It is a fair conclusion, therefore, that the CTO regime is somewhat less restrictive of a patient’s right to refuse treatment than Section 17 Leave, because a CTO does not confer any power to treat outpatients involuntarily who retain the capacity to consent. There is little difference between the two regimes, however, regarding the powers to treat patients who lack the capacity to consent (which may be a substantial proportion), and, ultimately, all patients on CTOs and Section 17 Leave can be treated without consent, regardless of their capacity, following their recall to hospital. The threat of involuntary treatment in hospital following recall therefore remains in all cases, and this may be the most important mechanism for the enforcement of compulsory outpatient care. The overall equation is thus still somewhat equivocal and, if the CTO regime is less restrictive of the right to refuse treatment than Section 17 Leave, that may balance out only its more restrictive aspects concerning the conditions that may be imposed on compulsory outpatient care and the consequences of their breach.

There is not space here to compare every feature of the two regimes, but the comparisons conducted above should be sufficient to support our claim that there is no obvious way to conclude which regime is the least restrictive overall. It is not safe to conclude that one is clearly more restrictive than the other, for two reasons: first, because the two regimes are very similar in many respects; and, second, because, when there are significant differences between them, these point, on some occasions, to Section 17 Leave being less restrictive and sometimes to the CTO regime.

Conclusions concerning the least restrictive regime

The conclusion we reach from such comparisons is that some indicators point to CTOs being more restrictive, whereas others point to Section 17 Leave. The two regimes simply have different kinds of impacts on different kinds of rights. Much will depend on the sequence of events in individual cases, and on how particular clinicians exercise their statutory powers. The indicators are too conflicting to reach any general conclusion about the least restrictive regime. Thus, the final legal principle we identified – that clinicians should always, when in doubt, allocate patients to the least restrictive option – cannot resolve our current dilemma because we cannot identify with confidence the least restrictive regime. Thus when clinicians encounter patients who meet the criteria for both Section 17 Leave and a CTO simultaneously, they could be lawfully allocated to either regime; they retain this important element of discretion. We incorporated that discretion into the methods for our research, taking the view that when patients met the legal criteria for both regimes, clinicians might allocate them at random between the two. In doing so, they would act lawfully, and would permit us to research the efficacy of compulsory outpatient care.

No general ethical justification for community treatment orders

No general ethical justification for the legal framework of the CTO can be provided from our analysis. The reason for drawing this conclusion emerges from even a cursory review of how the relevant ethical considerations identified should be interpreted in practice.

Community treatment orders are not the least restrictive alternative when it comes to providing care within community mental health services, although they were widely interpreted when introduced as being less restrictive than the use of legal powers of detention in hospital. The conditions that clinicians can place on patients’ care regimes means that these clinicians must have good ethical reasons for using CTOs over less restrictive ways of supporting patients in the community. If such reasons are not available, CTOs cannot be justified.

Although our analysis indicates that some patients, carers and psychiatrists talked about different ways in which patients can benefit from the use of CTOs, it must be recognised that there is no RCT-level evidence that such perceived benefits actually result in improved outcomes for patients. It is therefore not possible to argue that CTOs can be justified from these accounts of perceived benefits – medical, social or personal – that are seen to accrue for some patients for whom CTOs are used. In other situations, clear accounts of difficulties or specific harms that patients faced under the CTO regime were described.

When considering whether or not the CTO regime functions to respect patients’ autonomy, there is a stronger ethical case to be made that CTOs can, for some patients at least, promote self-determination. A number of respondents clearly viewed the imposition of a community-based legal power as aiding patients in managing their illnesses in ways that enabled them to take control of their lives and to engage in new activities. Equally, for other patients the evidence suggested that they were constrained in their ability to exercise their autonomy in similar circumstances.

Promoting patients’ autonomy: a limited justification for the use of community treatment orders?

We therefore found that in some limited situations, the promotion of patient autonomy could provide sufficient reason for using a CTO when the patient’s circumstances suggest to the clinical team that this legal power is required to enable the patient to pursue life choices and activities in line with his or her values. This would not apply if the patient’s autonomy could be promoted by another means, for example by making additional multidisciplinary personal and social support available to him or her.

How the ethical argument regarding autonomy is developed here depends on resolving a practical and conceptual tension between respecting a patient’s autonomy and promoting that patient’s autonomy. Although this tension has been examined to some degree within psychiatric ethics187 and applied to discussions about mental health practice in view of interventions such as advance mental health directives (also known as ‘Ulysses Contracts’ or ‘Joint Crisis Plans’188–191), it is not an issue that has been discussed in previous ethical analysis of CTOs.

Participants prioritised the promotion of autonomy over mere respect for autonomy when thinking about the ethical legitimacy of CTOs, and usually contrasted the use of CTOs with being an inpatient. This position is understandable; given the long-term nature of community-based mental health services, it should be seen as entirely appropriate to foster a person’s self-development and support his or her life projects into the future, rather than treating that person’s values and abilities as static. By way of caution, however, it should be noted that the recent evidence from an RCT of advance directives for mental health suggests that the promotion of patient autonomy through the use of such interventions may not lead to clinical benefits. 188 This implies that it is also important to look very closely at whether or not autonomous choice would indeed be fostered through the use of CTOs in any given clinical situation.

There are two additional difficulties in drawing on an ethical requirement to promote a patient’s autonomy to provide an ethical justification for the use of CTOs. The first difficulty is an epistemological one. Although it may be correct that, in some cases, patients’ abilities to pursue choices and activities better, in line with their own values, will be enhanced by invoking a CTO, it will be difficult – if not impossible – for CMHTs to know whether or not patient autonomy will be promoted in any given case. Even if there are a small number of situations in which CTOs ought to be used to support the delivery of empowering and person-centred care, it is far from clear whether or not mental health professionals will be able to identify, in advance, when such situations have arisen.

The second difficulty in mounting an autonomy-based defence of CTOs is that our analysis has revealed that it is not possible to differentiate features associated with the use of a CTO from features of the broader care environment in which this power is invoked. As such, making an ethical judgement about the use of CTOs cannot be separated from the broader ethical requirement that professionals have to tailor the delivery of care and support services in ways that promote patients’ autonomy. The majority of concerns highlighted in the interviews concerned perceived failings in how interventions provided to patients were used to support their care and treatment, rather than constituting evidence that CTOs by themselves were harmful or disrespectful of patients’ autonomy. Equally, the benefits that participants felt emerged through the use of CTOs were commonly presented as being contingent on the availability and appropriateness of other interventions designed to provide personal and social support to patients in receipt of care in the community: features that are independent of these legal powers in a number of jurisdictions.

If patients’ autonomy can be promoted through the more optimal provision of multidisciplinary forms of personal and social support within community services, rather than through the use of CTOs, this is to be preferred, as these multidisciplinary interventions do not impose comparable restrictions on patients’ freedoms. There is clearly much more to say about the practical and ethical aspects of delivering good care to patients with complex needs within community mental health services, and we return to this in the ULTIMA Ethical Analysis (see Part 4, Chapter 20). Notwithstanding this observation, however, this Ethical Analysis does suggest that it is indeed possible that, in some situations, a CTO might be judged by the clinical team to be a valuable or indeed necessary component of a package of community-based care that promotes the autonomy of a patient. When such situations can be identified with some degree of certainty, it would be ethically defensible to use a CTO if available. This observation does not, however, legitimate the use of CTOs in general, nor does it provide a strong rationale for the introduction of these powers in jurisdictions for which they are currently unavailable.

OCTET Trial and Economic Evaluation

One in five of the patients approached refused to participate, which may have skewed our sample. The sample was, however, similar to those in the other two RCTs of CTOs.

Patients who lacked the capacity to consent to take part in research were excluded from our trial. These patients were excluded because of the ethical difficulties involved in engaging people in research who are incapable of understanding the implications of taking part on their treatment. This was a small group (nine patients), as only patients who were ready for discharge to the community were eligible to take part, and patients in that position should not be acutely unwell.

The number of protocol violations was noteworthy (42 violations in the CTO group and 46 in the non-CTO group, as well as the three patients who were ineligible or withdrew), although this is far from unique in pragmatic effectiveness trials. 195 Three factors contributed to this result. First, the legal position underpinning the lawfulness of the trial (see Chapter 11) required each subsequent clinical decision to be entirely unconstrained by the patient’s randomised status. Consequently, clinicians could not be encouraged to persist with the randomised assignment. Second, recruitment of patients took place at the point that the clinical team decided to initiate supervised outpatient care. Finalisation of a CTO requires detailed consultation both within the team and with the patient and their family, which can take from a few days to several weeks. During this time both the patient’s clinical condition and the commitment of the team to the trial can vary.

Third, adherence to randomisation was compromised by reorganisation in almost all of the collaborating mental health services, particularly by the separation of inpatient and outpatient consultant responsibility. As a result, many patients passed to being treated by psychiatrists who were unfamiliar with the trial and who might have had different opinions about management. Although these protocol violations are illustrative of key factors affecting the operation of CTOs, they did not alter the findings of our well-powered trial and this was confirmed by our sensitivity analysis.

The OCTET Trial was originally designed to capture the experience of family carers as well as patients, but this aspect of the trial had to be abandoned because of the low response rate. To some extent this was not unexpected as the patient group in question often have limited contact with their family. Carer views were, however, included in the OCTET Qualitative Study.

The Economic Evaluation encountered the common problem of missing data, as some relevant information could not be obtained from either the patient interviews or medical records. We addressed this according to current best practice using multiple imputation of the missing data and a sensitivity analysis carried out on the complete data set. Although the results of the sensitivity analysis did not alter the main findings, the potential impact of missing data on the results cannot be fully estimated.

OCTET Qualitative Study

Although we report the views of patients, carers and psychiatrists in the Qualitative Study, we could not sample patient–carer–psychiatrist triads or did we sample other professions involved in the administration of CTOs, such as AMHPs. The aim of this substudy, however, was not to examine dynamics and outcomes in case studies, but to identify experiences of the mechanisms at work in the operation of CTOs. The majority of family carers whom we interviewed were parents, and the experiences and views reported by this group might have differed if the sample had included, for example, more siblings or spouses. It is a strength of the OCTET Qualitative Study that our maximum variation sampling strategy captured a range of views and experiences within, and across, the three samples, minimising the likelihood that the findings were associated with a particular team, setting or NHS trust.

OCTET Ethical Analysis

We did not examine some potential benefits of CTOs, such as any impact on families. Some family carers felt that this was an important issue. The potential benefit for society at large was also not something our study assessed and this was one of the issues featuring in the debate preceding the introduction of CTOs.

OCTET Capabilities Project

In developing the capability approach for this patient group, our method did not capture effects on informal carers’ capabilities or those of the wider community who were likely to be affected by the inevitable externalities of mental disorders treated in the community. This is not uncommon in this area and currently it is not clear how these aspects could be aligned. So far the closest attempt to capture similar externalities is the development of the Carer Experience Scale. 196 Neither is it yet clear how people’s ‘agency goals’,197 another fundamental concept of the capability approach, might or should be incorporated in any of the existing capability measurement frameworks as applied to health status assessment.

Background

Serious concerns have been raised that CTOs might lead to disengagement.

Objectives

Our objectives were to investigate the association between compulsion and disengagement; the effect of the trial randomisation arm on disengagement and readmission; the association between CTO use and readmission to hospital for patients who experienced time on a CTO; and the differential impact of baseline characteristics on the effect of duration of compulsion on discontinuity of care.

Methods

The OCTET Follow-up Study followed up the OCTET Trial cohort (n = 333) at 36 months after randomisation, collecting data from medical records. The primary outcome was the level of disengagement during the 36-month follow-up period. Secondary and tertiary outcomes comprised a range of hospitalisation outcomes.

Results

Rates of consistent clinical follow-up were much greater than expected (94% at 36 months). Just over half of the sample (n = 187, 57%) had no discontinuity in their care. There was no significant difference between the CTO and non-CTO groups in the number of discontinuities (IDR 1.12, 95% CI 0.78 to 1.59; p = 0.537). Longer duration of compulsion was associated with longer time to disengagement (HR 0.946, 95% CI 0.90 to 0.99; p = 0.023) and fewer periods of discontinuity (IDR 0.96, 95% CI 0.95 to 0.98; p < 0.001). There was no difference in any readmission outcomes over the 36 months. We did not identify a linear relationship between readmission outcomes and duration of CTO. We identified no effect of baseline characteristics on the association between compulsion and disengagement.

Conclusions

There was no evidence that increased coercion led to disengagement from services. There was no convincing evidence for improved hospitalisation outcomes from CTOs at 36 months.

Disengagement outcomes

Two variables were used to measure the level of disengagement during the 36-month follow-up period from the first discharge (the date when the patient left the hospital) to the end of the study:

1. Time to disengagement Disengagement was defined as no service contact for 90 days (or longer) and no return to contact. Time to disengagement was therefore calculated as the number of days from the point of first discharge from hospital to the last clinical contact, if that last contact occurred at least 90 days (3 months) before the end of the study follow-up period. This was a continuous variable, expected to be skewed. Data were censored for patients who died, emigrated or were discharged or imprisoned, and the 90-day period no contact requirement was calculated to that date rather than 1095 days.

2. Discontinuity of treatment over time This was defined as the number of time periods of 60 days or more in community care without a contact with services. This was a continuous variable expected to be skewed.

The explanatory variable duration of compulsion was defined as follows:

• Duration of compulsion This was defined for duration of total compulsion and for duration of community compulsion. Total compulsion was defined as the number of days under any legal compulsion (e.g. Sections 2, 3, 4, 136 or 37, CTO, and 40/48 of the MHA) during the 36-month follow-up period, including time under the initial Section 3 between randomisation and discharge to randomised status. This variable included inpatient and outpatient compulsion times.

• Community compulsion This was defined as the number of days in the community on a CTO and excluded inpatient compulsion. Time under voluntary status was not included in this variable.

Readmission outcomes

We used the following readmission outcome variables:

• Readmission to psychiatric hospital This was defined as a binary outcome (patient readmitted to hospital (voluntary and involuntary) during the 36-month follow-up period versus patient never readmitted).

• Duration of admission Number of nights of psychiatric hospitalisation from first discharge from hospital to 1095 days. This included voluntary and involuntary hospitalisations; nights on recall were not included unless the recall ended in revocation.

• Time to first readmission Number of nights from first discharge to first readmission. For patients (in both arms) who remained in hospital for the duration of the study, the time to first readmission was counted as zero. Nights on recall did not count as a readmission unless the recall ended in revocation.

• Number of readmissions from first discharge to 1095 days This included voluntary and involuntary hospitalisations but not any recall that did not end in revocation of the CTO.

Community treatment order compulsion outcomes

The following CTO compulsion outcomes were used for patients who experienced a CTO at any point during the study (non-randomised group):

• Duration of readmission Defined as above in Readmission outcomes.

• Readmission rate Defined as the proportion of patients readmitted to hospital (subject to the constraints mentioned under Readmission outcomes);

• Time to readmission Defined as the number of nights from the point of first discharge from hospital to the first readmission.

Disengagement

‘Time to disengagement’ is a time-to-event outcome. We therefore performed the analysis using a proportional hazards model adjusting for duration of compulsion and the stratification factors [gender (male/female), schizophrenia (yes/no) and duration of illness (< 2 years, > 2 years)]. We present the results as HRs with 95% CIs.

‘Discontinuity of treatment over time’ is a count outcome. We therefore analysed it using a negative-binomial regression model and adjusting for duration of compulsion and stratification factors. We present the results as IDRs, which are interpreted in the same way as relative risks.

We conducted this analysis for the whole sample (not splitting by trial arm).

Readmission

We conducted the analysis for the readmission outcomes using the intention-to-treat population. We analysed the readmission outcomes in the same way as the disengagement outcomes, using multiple regression models with adjustment for the stratification factors. The type of regression model depended on the data distribution. We assessed all model assumptions.

We compared the trial groups for time to disengagement with the non-parametric Wilcoxon rank-sum test because of the violation of the proportional hazards assumption of the proportional hazards model.

Similarly, the model used in the analysis for discontinuity of treatment was adjusted for trial arm, reporting its coefficient (and 95% CI and two-sided p-value) interpreted as an IDR.

We analysed psychiatric hospital readmission in the 36-month follow-up period, as a binary outcome, using log-binomial regression that was adjusted for the trial arm indicator and the stratification factors. We present the results as the relative risk of readmission in the CTO group compared with the non-CTO group, with appropriate 95% CIs and two-sided p-values.

The number of readmissions and duration of readmission are count outcomes. We analysed these using negative-binomial regression models and adjusting for trial arm indicator and the stratification factors. We present the results as IDRs.

The time to first readmission from first discharge to 1095 days is a time-to-event outcome. We therefore performed this analysis using a proportional hazards model, adjusting for the trial arm indicator and the stratification factors. We present the results as HRs with 95% CIs and also present Kaplan–Meier plots. We calculated the median readmission time with 95% CIs.

Community treatment order compulsion

Analyses of association of duration of CTO and readmission outcomes were conducted only on patients who had at least one CTO event so the sample size was restricted to 198 people. Owing to model assumptions violations, the explanatory variable CTO compulsion was split into quartiles.

We analysed the association between CTO compulsion groups and readmission rate using Poisson regression with robust error variances,199 as the log-binomial model was not possible because of model instability. The results are presented as relative risks with 95% CIs.

We performed the analysis for the time to readmission using the non-parametric Kruskal–Wallis test. The proportional hazards model was not used because of the violation of the proportional hazards assumption.

We analysed the duration of readmissions using a negative binomial regression model adjusting for the categorical CTO compulsion and stratification factors. We present the results as IDRs with 95% CIs.

Sensitivity analyses

We conducted a sensitivity analysis for the variables measuring the disengagement outcome, which consisted of repeating the above analyses without adjusting for the stratification factors.

Subgroup analyses

To identify patients’ baseline characteristics associated with a differential effect of duration of compulsion on discontinuity of care, we fitted the same model as for the disengagement outcome, with the inclusion of an additional interaction effect for the interaction between the duration of compulsion and the relevant subgroup variable. The p-value for the interaction test was the p-value of interest, as this was the test of the stated hypothesis. The significance of the compulsion variable was not considered of interest here.

We evaluated the following groups, defined a priori, the first three of which were stratification factors:

• gender: male versus female

• diagnosis: schizophrenia versus other

• duration of illness: < 2 years versus ≥ 2 years

• age: ≤ 40 years versus > 40 years

• ethnicity: white versus others

• born in UK: born in UK versus born in another country

• marital status: (single + separated/divorced) versus married/cohabiting

• accommodation: independent versus (supported + homeless)

• living status: living alone versus living with others

• educational level: ≤ 12 years versus > 12 years; tertiary education (yes/no)

• BPRS: ≤ 33 versus > 33

• GAF: ≤ 49 versus > 49.

A centre effect was evaluated through a similar subgroup analysis for both the disengagement and readmission outcomes. The subgroups were defined by the variable:

• centre: London versus other sites.