The Patient Centred Assessment Method for improving nurse-led biopsychosocial assessment of patients with long-term conditions: a feasibility RCT

Aims

• To assess the acceptability and implementation requirements of the PCAM tool for use in UK primary care, particularly in the context of PN-led annual reviews for people with LTCs.

• To examine fidelity of the use of the PCAM tool by PNs in routine annual reviews of LTCs.

• To assess the feasibility of conducting a full-scale trial of the effectiveness of the PCAM tool based on two potential units of analysis, namely intermediate-level nurse behaviour and longer-term patient well-being.

Study A: acceptability and implementation requirements of the Patient Centred Assessment Method

The PCAM [formerly known as the Minnesota and Edinburgh Complexity Assessment Method (MECAM)] tool was derived from ‘INTERMED’, which was developed for use in acute settings. The INTERMED assessed biopsychosocial aspects of the patient and how they related to the health-care system, which, taken together, reflect ‘case complexity’. 17–19 The purpose of the PCAM tool was to provide a practical but systematic vocabulary and action-based evaluation system that could be applied to a primary care setting to improve the care, and self-care, of patients with multiple (complex) needs. An early version, the MCAM, was developed in the USA for use by clinical teams (doctors and nurses) for the case management of patients with medically unexplained symptoms. 19 Although the conceptual basis for assessing complexity has been established via the INTERMED and MCAM, further adaptation and validation was required for use in a UK health context. This has been undertaken by the current team in the context of adapting it for use in Keep Well health screening consultations. This resulted in the development of the PCAM, as an adapted version of the MECAM, for use in the UK. It was successfully implemented and evaluated with seven Keep Well nurses, and was shown to increase non-medical referrals, especially to psychological, social and lifestyle referrals. 20 Use of the PCAM tool was embedded into the Keep Well assessment by NHS Lanarkshire and was reported by the service lead to be making ‘a real difference’ to nurse engagement with the mental and social well-being of patients. The PCAM tool is also in use in the USA, where it is undergoing further testing.

It was therefore a reasonable theoretical assumption that the PCAM tool could be of value for primary care nurse engagement with the mental and social well-being of their patients with LTCs who are at higher risk of poor mental health and social problems. However, the ‘Keep Well’ context is not entirely comparable to routine primary care. ‘Keep Well’ services involved anticipatory health checks among ‘at-risk’ populations, with more time available at each consultation. The PCAM intervention had not been reviewed by GPs or PNs, and neither had its usability and acceptability been evaluated in primary care. Furthermore, there had been no patient input to the use of the PCAM tool. This initial study aimed to assess its ‘face validity’, acceptability and implementation requirements for use with PNs and their patients with LTCs. We would also gain qualitative knowledge surrounding primary care professionals’ views and readiness to conduct biopsychosocial assessments, and whether or not this tool could prove useful to GPs in their management of depression.

This study of ‘face validity’, acceptability and feasibility of primary care nurse use of the PCAM tool was conducted via focus groups with primary care practice teams. The inclusion of different members of the practice team was important, given the role of primary care nurses as ‘employees’ of the practice, whose work is determined by the practice (GP partners). The use of the PCAM tool also requires that other appropriate professionals may need to be called on if the nurse has identified areas of need, especially urgent needs. As the PCAM tool should facilitate nurse assessment and signposting to other professionals, including GP colleagues, ‘how’ the PCAM tool would work at a practice level was also important. In addition, as the role of practice managers (PMs) in implementing new initiatives in primary care was also taken into account, these members of staff were also included in the focus group study in assessing the feasibility, acceptability and implementation requirements for the use of the PCAM tool.

The discussion of the implementation of the PCAM tool at a practice level, as well as nurse use of the tool, and the discussion of adaptations that might be needed at a practice level (e.g. more time for nurse consultations in the early stages of use) made the focus group methodology and the inclusion of the primary care team appropriate.

Study B: feasibility study of a cluster randomised controlled trial of using the Patient Centred Assessment Method intervention in primary care nurse assessments of patients with long-term conditions

A feasibility study aims to assess the acceptability and practicality of a proposed project, and whether or not an intervention should be recommended for efficacy testing. 21 This feasibility study sought to assess the feasibility of the intervention for use in primary care, test the methods and protocol for a future trial of the PCAM intervention and consider whether or not it should be recommended for efficacy testing. This also included assessing which outcomes were feasible to collect and which outcomes may perform better or be more likely to detect change or improvement as a result of the intervention.

The recruitment of practices, and nurses within these practices, raised the possibility for two levels of clustering (practice and nurse level), and the question of whether or not a matched pairs design would be possible or more appropriate. There was the possibility that there would be more variation between nurses than between practices, and the decision to randomise at the level of practices was somewhat pragmatic; it was intended to reduce the number of practices needed to recruit sufficient nurses and to minimise nurse contamination caused by exposure to the PCAM tool of the nurses randomised to care as usual (CAU), if other nurses in the practice were using the PCAM tool. However, this feasibility study also had an added complexity in that there were two levels of outcome that were being observed: change at the level of the PN and change at the level of the patient. Therefore, nurses would also be included as a unit of analysis, and we determined patient recruitment to enable this. Although the overall design of the feasibility trial is complex (with baseline and follow-up being conducted both before and after randomisation of practices), this was necessary to observe changes at both the nurse level (where patients are also evaluating nurses’ caring behaviour) and the patient level.

A matched pairs design is used to explicitly control for confounding variables to eliminate the bias of these variables. We could have aimed to match nurses based on criteria likely to influence their delivery of the PCAM. However, besides assumptions of nurse experience being important, we do not currently empirically know which nurse characteristics should be included in any block allocation of pairs. We thought about which factors could be confounding and, therefore, included nurse demographic and clinical experience data alongside (patient-reported) caring behaviour as the most likely explanatory variables we could control for in a future matched pairs design. However, if we had paired nurses in this current study, we would have needed to recruit all nurses from different practices, as we could not have nurses from the same practice being paired to receive training or no training; the potential for nurse contamination was too great. This would have increased the overall number of practices required. Our chosen design of a cluster randomised trial with the practice as the unit of cluster would enable us to decide whether or not nurse variables are a significant bias that would necessitate a matched pairs design for a full trial.

Randomisation of matched pairs at the patient level (even if we also knew the likely confounding variables at this stage) would require PCAM-trained and untrained nurses to exist within the same practice and risk contamination, or for patients from one practice to be sent to another practice for their LTC consultation. Apart from the inconvenience to patients, it is likely that caring for another practice’s patients would result in changes in nurse behaviour. It would also add significantly to the complexity, costs (researcher input for patient consent to randomisation and a lengthy recruitment process) and ethical concerns of this study. A design based solely on patient outcomes would not allow for studying any changes or impact on nurse behaviour.

We aimed to conduct a feasibility study (not a pilot of ‘fixed’ trial methods) and hoped to use our findings to determine the best outcomes and units of analysis, and to determine whether our ‘efficient’ design (based on ease of recruitment of practice, nurses and patients) was robust or if confounding variables would need to be controlled for in future randomisation processes.

Studies or trials of complex interventions also allow for the inclusion of more than one primary outcome. A feasibility study can help to determine which outcomes are more likely to be able to detect sufficient levels of change, and the degree of change observed can help to determine the likely numbers needed in a full trial to detect a sufficient level of change. This study was set up to include the collection of potential measures of change in nurse behaviour, as well as the collection of a set of measures relating to outcomes for patients. Nurse behaviour change was measured in several ways: patient assessment of the nurses’ consultation skills, as measured by the Patient Enabled Instrument (PEI)22 and Consultation and Relational Empathy (CARE)23 measure; changes in nurse confidence with mental health, as measured by the Depression Attitude Questionnaire (DAQ);24 changes in nurse consulting behaviour, as observed before and during the PCAM intervention via the recorded and coded consultations with patients; and changes in nurse referral patterns collected before and during the PCAM intervention.

Patient assessment of nurse consultation skills (measured by the PEI and the CARE measure) can be measured only post consultation; therefore, this necessitated obtaining baseline scores for all nurses before they were randomised to the PCAM intervention or CAU and after randomisation. This then resulted in two cohorts of patients being recruited at baseline and after randomisation. The longer-term outcomes for patients following their consultation were also followed up for all nurses at baseline and post randomisation. The inclusion of nurse baseline assessment added to the complexity of the design of this study, but this serves to demonstrate the need for alternative trial methods when multilevel interventions are delivered in complex care settings such as primary care.

Patient outcomes were assessed by the General Health Questionnaire (GHQ),25 the Short Form questionnaire-12 items (SF-12)26 and the Warwick–Edinburgh Mental Well-Being Scale (WEMWBS)27 immediately post consultation and at the 8-week follow-up.

Study C: fidelity of use of the Patient Centred Assessment Method by nurses

Taking an approach based on the early work of Engel,28 the aim of the PCAM is to encourage more holistic consultations by primary care professionals (in this study, PNs) and to ensure that nurses pay attention to a broader range of the biopsychosocial needs of patients. This is done within a patient-centred framework and a chronic disease management model.

There have been many theories and models derived from the analysis of structures, processes and outcomes occurring during traditional medical consultations. 29–32 More recently, these have included the role of the patient in health-care provision, with the aim of improving quality outcomes for patients. 33,34 However, the majority of ‘consultation’ work in primary care has been focused on the interaction between the patient and the GP, with little attention to nurse consultations. More recently, with attention to changing roles in primary care, such as the ‘nurse practitioner’, there has been some discussion around which of the existing (medical) consultation models might apply to primary care nursing. 35–37

In a similar vein, there are validated coding tools for assessing communication skills and empathy in medical consultations, such as the Verona Coding definitions of Emotional Sequences,38,39 a consensus-based system for coding patient expressions of emotional distress in medical consultations, defined as cues or concerns, and the Roter Interaction Analysis System40,41 as a method for coding medical dialogue. However, these would not meet the needs of this study in assessing whether or not nurses were implementing the PCAM tool as intended, which should be assessed by determining whether or not nurses did indeed explore the biopsychosocial needs of patients and whether or not they did this in a patient-centred conversation, as opposed to a ‘tick-box’ exercise. The study therefore required the development of a bespoke coding frame, and one that could be applied systematically by more than one researcher to recorded transcripts of nurse–patient interactions.

We developed a coding system for classifying conversation segments according to whether or not they address any of the domains/items within the PCAM tool (and which ones are discussed), whether or not they identify or acknowledge needs against each of the domains and whether or not they discuss potential actions against each of the domains. This coding frame was then applied to recorded consultations with a sample of nurse–patient interactions that occurred both before and after the nurses were trained in the use of the PCAM tool in order to understand whether or not they were already consulting in a way that helped to address biopsychosocial needs or if there had indeed been a change in their behaviour following training and use of the PCAM tool. The specific coding system and the analysis of recorded consultations is reported in Chapter 5.

Study D: nurse and patient perceptions of using the Patient Centred Assessment Method in long-term condition annual reviews

In assessing the acceptability and feasibility of using the PCAM tool in primary care, it was important to gain some perspectives from nurses and their patients following nurse use of the PCAM tool in patient consultations. All nurses who were allocated to receive the PCAM intervention were invited to participate in a qualitative interview of their experiences of its use. For those patients recruited by nurses to complete outcome-based questionnaires, the follow-up questionnaire contained an invitation for patients to also participate in a follow-up interview if they wished. Individual interviews were chosen because the numbers involved were small (maximum of eight nurses and two patients per nurse), and individual rather than ‘group’ experiences were important to capture at this stage. Patients were asked about their own personal experience of the consultation and any advice or actions that the nurse had initiated at this consultation.

Study E: process evaluation

A qualitative process evaluation was conducted in order to identify possible contextual influences on both the implementation of the PCAM and the feasibility trial, and to identify any barriers to PCAM use or implementation of trial processes. This consisted of data from the early focus groups with practices and patients on the acceptability and feasibility of use of the PCAM, researcher field notes of meetings and discussions with staff and any comments made to the research team or reported by practice staff from patients during implementation, data from the final interviews with practice staff and patients, and open-ended questions on staff and patient questionnaires. The process evaluation was based on the Medical Research Council (MRC) guidance for best practice and its key components as identified by Moore et al. 42 (Figure 1).

FIGURE 1.

Key functions of a process evaluation. Based on Moore et al. 42 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

Based on Moore et al. 42This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

The process evaluation aimed to gather knowledge around the implementation or use of the PCAM tool in primary care as well as around the implementation of the proposed trial methods in each of the different practice settings. The intervention description and its causal assumptions are described in The Patient Centred Assessment Method: intervention description. This will be reflected on in Chapter 7, in which the data on context, implementation and mechanisms of impact are described, including how these differed across sites.

The Patient Centred Assessment Method tool

The PCAM tool involves nurses making an assessment of their patient in each of the following domains:

• health and well-being (covering physical health needs, the impact of physical health on mental health, lifestyle behaviours, mental well-being)

• social environment (covering home safety and stability, daily activities, social networks and financial resources)

• health literacy and communication (covering understanding of symptoms, self-care and healthy behaviour and how engaged the patient is in discussions)

• service co-ordination (how comprehensively, and efficiently, health and social care services currently meet patient needs).

These then lead to action-oriented tasks to deal with the identified problem, which may include referral or signposting to other professionals or agencies. The PCAM tool is provided in Appendix 2.

Patient Centred Assessment Method training

The training was designed to give nurses an understanding of the social determinants of health and how social factors can influence morbidity and mortality. They also learned about the comorbidity of physical and mental ill health, building a picture of why it is important to conduct biopsychosocial assessment and address broader health needs. They were then introduced to the PCAM tool and discussed ways in which knowledge of patients’ circumstances can be elicited as part of a conversation (not a tick-box exercise), and in a naturalistic way that builds on their communication skills. For more detailed information about the PCAM training, see Appendix 3.

Patient Centred Assessment Method resource pack

The PCAM resource pack is a list of local, regional or national groups, organisations and information sources for use by PNs as potential signposting/referral opportunities for patients with LTCs.

Referral and signposting opportunities presented within the resource packs were those covering psychosocial problems within the PCAM domains. For more detailed information about the PCAM resource pack, see Appendix 4.

Control or ‘care as usual’

Nurses in control or CAU practices delivered CAU to their patients. Until April 2016 in Scotland, this was guided by the requirements of the QOF for LTCs, such as DM and CHD. During the development of this study and its funding, the QOF requirement for screening for mental health problems in LTCs was removed, but nurses could still, and indeed were encouraged by NICE guidelines to, include some attention to mental health and well-being in their annual assessments. Normal referral systems or pathways of care would be maintained for patients in the CAU practices.

Quantitative analysis

The primary outcome of the pilot trial was to determine recruitment and retention rates of PNs, and the recruitment of patients and data completion for a future cluster RCT. We also wanted to establish which nurse- and patient-level measures should constitute primary and secondary outcomes for a future cluster RCT and, hopefully, use this knowledge to determine sample size for a future trial. The study combined data collection for nurses and patients as two separate units of analysis. One of the criteria for continuation to a full-scale trial would be to determine if the number of nurses required for a cluster RCT was feasible and within reasonable cost boundaries. Such a design would also need to be sufficiently powered at the patient level, thereby testing the impact of the PCAM tool on both nurse behaviour and patient outcomes.

The characteristics of the nurses and patient groups and their related outcome measures were summarised using descriptive analysis. The related outcome measures were summarised using descriptive analysis together with estimates of precision, and any relevant change scores. Some modifications were made to the statistical analysis plan that was created at the time of requesting funding for the study. Since then, there has been a shift in expert guidance advising against all formal significance testing for pilot and feasibility study outcome measures, as these are not powered to detect statistical significance. Therefore, formal significance testing was omitted, as was the use of the multiple regression modelling approach. The focus of the analysis centred on the recruitment, data completion and attrition rates, and making use of descriptive analysis to summarise the data. The PEI and CARE measures were analysed at the nurse level and the 12-item General Health Questionnaire (GHQ-12), SF-12 and WEMWBS were analysed at the patient level. Both units of analysis were summarised between randomisation groups, using means and standard deviations, or medians and interquartile ranges, together with change scores estimated with their 95% confidence intervals (CIs). The number of practices recruited and the number of nurses recruited were less than planned, and this also ruled against the use of formal regression models to explore the influence of covariates on outcome measures. In addition, as the number of clusters was so low, and as some of the follow-up data were missing, the estimation of the ICC for the outcome measures was not appropriate.

Qualitative analysis

Qualitative data analysis of focus groups and interviews followed the social constructivist version of grounded theory, through which themes and subthemes were identified in the data. 47,48 The social constructivist approach is an iterative process of review that allows for the incorporation of existing knowledge and literature that can be drawn upon in the analysis process. 47,48 NVivo 11 (QSR International, Melbourne, VIC, Australia) software was used to help facilitate the interviews. In an iterative process, all focus group transcripts and interview transcripts were reviewed by multiple team members to identify key themes in relation to our research questions. These themes were discussed and amended until a core set was agreed for use as a final coding frame, which was systematically applied to all data. The research team met throughout the analysis process to review the emerging themes and discuss areas of agreement or divergence until consensus was reached. Additional details on the qualitative data analysis are included in Chapters 3 and 6.

The analysis was specifically intended to identify barriers to, and facilitators of, adoption/use, and was informed by the normalisation process theory (NPT). 49 The NPT offers an explanation of the work of implementation, embedding and integration, and specifically focuses on the contribution of individuals and groups as agents of change. The NPT helps to explain how practices can become embedded in organisational and professional contexts. There are four generative mechanisms to help explain how change can be adopted and embedded: coherence (sense-making), cognitive participation, collective action and reflexive monitoring. The production and reproduction of a practice requires continuous investment by agents (in this case, PNs) over time. NPT mechanisms are constrained (or aided) by the operation of norms (notions of how beliefs, behaviours and actions should be accomplished) and conventions (how beliefs, behaviours and actions are practically accomplished).

The NPT generative mechanisms and their constructs have provided a framework for analysis of the qualitative data, to help understand and think through implementation problems and to help identify techniques to solve them. This was drawn on at the start of the project, using the focus group data, to help shape improvements to the implementation process and the training materials. Researcher field notes and post-implementation interviews were then also subsequently used to identify further barriers to, and facilitators of, adoption.

Analysis of audio-recorded consultations

The analysis of audio-recordings consisted of classifying conversation segments according to whether they attended to physical health, mental well-being or social elements of care. The range of social circumstances attended to were also identified. The PCAM tool should encourage a conversation flow that attends to well-being and social circumstances throughout the consultations (not leaving it until the end, when time may be limited). The analysis, therefore, also included attention to when conversation segments appeared in the consultation. Attending to a mix of physical health, mental well-being and discussion of social circumstances through the consultation, and discussing a range of social circumstances, was considered to be maintaining fidelity to the PCAM tool. It could be the case that nurses were already familiar with a patient’s social circumstances, but they would still be expected to enquire about these – to ask how patients were getting on or about any change in circumstances. A list of codes by which to classify segments, based on the domains within the PCAM tool, was developed by the research team and consistently applied to all consultation recordings before and after nurse training in the use of the PCAM tool.

Integration and synthesis of data sets

Overall, the qualitative and quantitative analysis aimed to determine whether or not and how a future cluster trial should proceed. This included assessing whether or not recruitment, retention and data collection were achieved to a sufficient level, and whether or not the outcomes used were sensitive enough to detect change (at what level and for whom), as well as identifying any key methodological issues in converting from a feasibility or pilot trial to a full-scale trial, as established by Shanyinde et al. 50 We used a tool known as ‘A process for Decision-making after Pilot and feasibility Trials’ (ADePT). 51 The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial. The ADePT decision aid is described and reported alongside the process evaluation in Chapter 7.

Introduction

Embedded in the overall PCAM study, this first project was designed as a qualitative study of GP practice staff, including PNs, and patient views of the acceptability and implementation requirements of the PCAM. The project aimed to elicit views on the PCAM approach as a model for conducting reviews of patients with LTCs and to identify barriers to, and facilitators of, the implementation of the PCAM tool in practice.

Recruitment and sample

Ethics considerations

Participants were asked at the start of each focus group discussion to not mention the names of staff or non-participants, and to respect the confidentiality of other participants. Researchers also informed patients that if they raised any questions in relation to their personal health issues during the focus group discussion, researchers could not respond to these and they were, therefore, advised to contact their GP.

Data collection

All focus groups were conducted using topic guides as a framework for discussions. Professional groups aimed to address the implementation of the PCAM tool within annual reviews of patients with the LTCs specified, along with determining any potential barriers to the use of the model and how these could be overcome. As the NPT was used as an analytic framework, the topic guides aimed to identify whether or not, and in what ways, nurses and other practice staff considered the PCAM to differ from existing ways of working; whether or not nurses and GPs could come to a collective agreement on the purpose of the PCAM; how practice staff understood what the PCAM required each of them to do; whether or not nurses and other practice staff constructed a potential value for the PCAM in the context of annual reviews; and whether or not nurses and other practice staff believed that the PCAM was an appropriate part of their work. Practical issues relating to the implementation of the embedded feasibility RCT and the PCAM in general were discussed to allow consideration to be given to how the individual requirements of different practices might be taken into account. This included discussion of what training may be needed to enable the use of the PCAM and how this could be delivered.

Patient focus groups aimed to discuss how wider psychosocial factors impacted on patients’ health and also how their LTC(s) affected their lives. Topics for discussion included what support patients needed to manage their conditions and whether or not primary care practitioners should play a role in helping them to manage life difficulties that might, potentially, have an impact on their health. The PCAM was then explained to patients and they were invited to discuss whether or not it was acceptable to them and whether or not they considered it useful in relation to their care. Patients were asked how PNs might best raise sensitive or difficult issues with them, and they were also asked about any potential barriers that nurses may experience in using the PCAM.

Data analysis

Data analysis involved constant comparison of key ideas/themes emerging from multiple staff reviews of focus group transcripts. Carina Hibberd, Eileen Calveley and Patricia Aitchison reviewed and compared patient and staff focus group transcripts as they became available. Use of the constant comparative technique within the ‘framework’ method enabled the identification of emergent themes for exploration in subsequent focus groups. 52

Data sources (focus group transcripts) were imported into an NVivo 11 database, which was then used for data management and the facilitation of analysis. Data from staff and patient focus groups were organised separately within the database. Only designated members of the research team had access to the database.

Carina Hibberd, Patricia Aitchison and Rebekah Pratt conducted initial, independent thematic analyses of focus group transcripts to devise a coding frame that was then discussed in detail by the wider analysis group (CH, PA, RP, EC and MM). Where required, analytical codes were amended at this stage by Rebekah Pratt, and descriptors were created to avoid duplication or lack of clarity in meaning. Rebekah Pratt recoded the entire data set based on the amended codes.

From this thematic analysis, a higher-level theory-driven analysis was conducted to organise coded data into more helpful explanatory themes, with attention given to reflecting on these explanations for participation, engagement, adoption and adaptation in line with NPT constructs. For the purposes of this report, the key elements of analysis that are relevant to the acceptability and feasibility of using the PCAM tool in primary care-led annual reviews for LTCs, and for answering questions on the feasibility of a cluster RCT, are presented. The theory-driven NPT analysis will be presented in a future publication.

Recruitment of practices

Figure 3 shows the number of GP practices contacted and subsequently recruited for focus group participation. Four practices agreed to take part in focus groups following telephone contact by researchers, two practices within NHS FV and two practices within NHS GGC. Our recruitment target for the number of focus groups was met.

FIGURE 3.

The recruitment of practices to the focus group study. ISD, Information Services Division of National Services Scotland; LINKS, National Links Worker Programme (funded by the Scottish Government to make links between people and their communities through their GP practice).

Recruitment to staff focus groups

Sixteen health-care staff participated in the four focus groups. Participating health-care staff included PNs (n = 7), GPs (n = 3), PMs (n = 3), assistant PMs (n = 1) and administrative/reception staff (n = 2). The duration of staff focus group sessions ranged between 47 and 72 minutes. The four staff focus group sessions were held in the GP practice.

Recruitment to patient focus groups

Two of the four participating GP practices agreed to host a patient focus group. A total of 27 patients returned a note of interest, of whom one could not be directly contacted, seven declined or could not attend, two agreed but did not attend and 17 attended and consented. As intended, patient focus groups included a mix of age groups and sex, and reflected the social demographics of participating practices (Table 1).

One patient focus group was held in the GP practice, and one patient focus group was held in a local community centre because of limited meeting space in the GP practice. The duration of each patient focus group was 105 minutes.

Patient perceptions of living with a chronic illness

Participants described the struggle of coming to terms with living with a chronic illness. Some described a tension between rejecting their diagnosis and accepting the limitations of their condition, and how that had an impact on their ability to manage their condition. Some had been told that they had DM, but felt that being asymptomatic made it hard to believe that they really did have the condition. Some described spending time, even years, in denial about their condition. This rejection of their condition led to avoidance of doctors, being scared of coming to the clinic, not taking medications and not looking after their health. One participant reflected on rejecting her condition after a negative experience with her GP, and is now facing serious kidney damage.

Participants also reflected on the process of coming to terms with their condition, often describing a period of surprise followed by learning how to adjust and adapt to managing their condition. Some noted that there could be experiences that had a negative impact on their confidence, which may take some time to rebuild. Some described a longer process of having to come to terms with more than one condition, which may lead to more complications and care in managing their health.

During the focus group session, participants shared with each other the many limiting aspects of living with their particular condition. Some were feeling generally well, but others were navigating more complex medical needs, such as surgery and therapies. Many reflected on various losses, such as limiting their food or activities. Participants also described feeling the need to just carry on and make the best of their situation. Some felt that they should be grateful and took comfort in feeling that things could be worse:

But other than that I’m just quite happy, jog along, but every day’s a different day of course you just . . . what I can do today, I’m fine if I can, well tomorrow, but tomorrow doesn’t come, but I just suit myself how I jog along kinda thing, but as I say I can’t complain when I listen to what other people have got, you know, but I’ve enough to be going on with quite honestly [laugh]!

Patient 14

In relation to managing physical aspects of a chronic condition, participants described a period of learning about their condition, mostly through medical appointments and the development of systems to keep track of timing medications. However, participants described their challenges as not just being related to the management of their condition, but also dealing with limitations in daily life more broadly. A small number of participants in the focus groups described very positive, and even life-changing, experiences of taking part in exercise courses (as suggested by their nurse). These participants felt that exercise had led to positive changes in weight, wellness and mood:

So I went on that course and it was 12 visits to the course over a few weeks/few months, and I found that’s been a great help. What it’s actually done to me is it’s not only helped my COPD, it’s helped me mentally because I’m quite a shy person and I want to help myself but I can’t, I want people to help me but because my wife looks after my every need, but it’s to force me to get my a*** off my chair and go and do something.

Patient 34

Participants talked about how difficult it could be to make changes in their lifestyles, even when they knew that it would help with their health. They felt that changing habits around eating required constant attention and monitoring. Some felt that it was hard to ask for help with changes, partly because it took away feelings of independence. Some participants described how they also needed to manage their mental health, as there were difficult days of feeling down or not coping, and a tendency towards self-isolation:

You want to stay in and put a blanket round you but you’ve just got to kinda’ motivate yourself.

Patient 32

Although learning about their condition and how to manage it was a process participants went through, they also described the impact of their condition more widely, in terms of challenges with daily activities and lifestyle adjustments. In this sense, PCAM-related topics are consistent with the broad range of concerns that patients have about their condition.

Professional and patient views on acceptability of Patient Centred Assessment Method topic areas

Professional and patient participants were asked to reflect on how they would feel about a broader range of biopsychosocial questions, as is reflected on the PCAM assessment, being discussed in consultations relating to LTCs. To a certain extent, patient participants felt that their nurses already asked a broad range of questions about how they were and, in particular, participants felt that district nurses might observe more social and environmental aspects of a patient’s life on home visits. There was a wide range of opinions on how participants felt about the potential of being asked about biopsychosocial aspects of their health. Professional participants also reflected on this wide variety of opinions, with some participants much more familiar or comfortable than others with asking patients about the broader context of their lives. In Mental health, Health literacy and Social environment and finances, we discuss responses to these potential discussions for patient and professional respondents by general topic area.

Patient views on the Patient Centred Assessment Method implementation in long-term condition annual reviews

Patient and professional participants were asked to describe the ways in which conversations about their broader biopsychosocial experience would fit into the current relationship between nurse and patient, and into the current delivery of care for patients living with LTCs, particularly in relation to annual reviews.

For patients, contact with primary care was described as usually being in the form of doctor visits, nurse visits or condition-specific nurse-led clinics. Patients also described having their annual review, in which there were checks of their health, including a check of their feet and eyes for those with DM. There was a mix of views on whether or not the care being provided was sufficient. Some participants, particularly those who had been fairly recently diagnosed with their condition, felt that there should be more careful monitoring of how they were managing their health. Others appeared very satisfied with the amount of care they received, and described having useful referrals put in place for things like exercise. Some participants seemed to be much more proactive than others at connecting to their GP surgery and asking for the help they needed, whereas others were hoping that there would be more outreach to them as a patient, to check on how they were managing their condition.

Participants were asked to describe their experience of engaging with primary care in relation to managing their LTC. In general, participants spoke about valuing their doctors and felt pleased with the care they provided overall. It was particularly valued when it was possible to have continuity in care, and when patients felt that they had enough time to talk about their health concerns with the doctor and that they were treated as an individual and with compassion. There was some discussion for this group of participants about how the role of the doctor has changed over their lifetimes, and those changes were generally seen as leading to less personally connected relationships with the doctor:

I think one of the things that used to happen that doesn’t happen now is that you don’t see the same doctor all the time, you know, whereas in the old days when you paid half a crown the doctor would say ‘oh aye your grandmother, aye yes you may have the same, I’ll keep an eye’, they knew about you personally and your relations and everything, but nowadays it’s . . . well most of them only work three days a week.

Patient 19

Some described feeling that the doctor was the authority figure in the clinic, the one that makes key decisions about medication and care, or who might express concerns about how the patient is managing their condition. Those participants who had talked about rejecting their diagnosis also described avoiding the doctor to avoid such interactions, even if they knew it might have negative consequences. Nurses were described as having more personal relationships with patients, with more time to spend with them during regular reviews and check-ups. The relationship was described as one in which there was more accessibility, time and generally more supportive care. Nurses were also described as suggesting activities such as exercise or weight loss, rather than being medication focused. The nurse was described as less of an authority figure than the doctor, but still as an authority figure to be respected and listened to:

Yeah, my wife turns round and tells me to go on a diet and I go ‘aye OK’, you know, a nurse tells me to go on a diet ‘aye, yeah’ ‘oh you’re losing weight!’ and you turn round and say to your wife . . . I don’t know, ‘go on the scales’ ‘no’, but if your nurse turns round and tells you to do it you’ll do it!

Patient 34

In addition to the areas of discussion that might be presented by the PCAM tool, the participants reflected on how, in their view, asking such questions related to how they see the role of the nurse. Some participants felt that nurses might not have the skills and training required to ask such questions of their patients and, in that sense, it was asking nurses to go beyond their current role. However, participants were more concerned with protecting nurses from being overcommitted by being asked to do another task on top of an already significant range of responsibilities. There were concerns that nurses needed to have their time somewhat protected, and the boundaries of their role more clearly defined.

There was also discussion in the focus groups about the role of nurses and what they would do with information gathered with a tool such as the PCAM. There was a sense, for some participants, that nurses should be distinguished from social workers, and not ask questions that would be more typically asked by a social worker, who was seen as more likely to act on any concerns identified by these questions. For these participants, there were concerns about nurses asking about things they might not be able to provide assistance with. Other participants saw nurses as being appropriate to talk to about any issue that might have an impact on health, and those participants tended to see the nurse as a resource who could refer a patient to a social worker, or other services, as required:

She’s not got that teaching, she’s not got that know all but she could refer you, say to you ‘right you are, we are lucky to have a social worker who’s available at certain times in the month or certain times in the year that you can maybe go and have a private conversation with’ and you don’t have to tell anybody, it’s just an appointment from A to B and that’s it. And then you would come in here as if you’re coming in for a normal appointment and speak to a social worker privately.

Patient 34

In summary, when patient participants felt that it was appropriate to be asked the PCAM-related questions, they felt that the nurse was an appropriate role for leading that conversation. It was felt that nurses could connect patients to resources as needed, and that the supportive relationship with the nurse was conducive to talking about these topics. For those who did not feel that it was acceptable to be asked the PCAM questions, they did not feel that it was appropriate for the nurse to ask such questions, and tended to see it as a social worker role.

Professionals’ views on the Patient Centred Assessment Method implementation

Professional participants were asked to explore how the PCAM assessment might fit in with their usual work of caring for patients with LTCs. Their input reflects the split in opinion about the acceptability of the the PCAM tool, with a variety of views about the potential impact of implementation. In The Patient Centred Assessment Method in the consultation, Relationships with patients and The connection to resources, we discuss their views in relation to the consultation itself, their relationship with patients, their approach to care and the availability of resources.

Design

The feasibility RCT element of the PCAM study used a cluster RCT design to assess the acceptability and feasibility of conducting a full-scale trial of effectiveness. With the GP practice as the unit of cluster, it considered pre- and post-implementation outcomes for two units of analysis, that is, nurse and patient levels.

At the nurse level, the RCT collected baseline data of nurse behaviour for all nurses in order to consider whether or not change had occurred in both the control and intervention arms. This was followed up after completion of phase 2. At the patient level, patients were asked to complete baseline data and data at 8 weeks’ follow-up in both phases of the trial, with a separate cohort of patients in phase 2.

Randomisation was conducted by the study statistician at the end of phase 1 data collection and independently of the broader research team. The decision was recorded, and practices were then informed of their allocation by Carina Hibberd.

Practice recruitment

The feasibility RCT aimed to recruit eight medium-sized to large GP practices in three locations, FV, Grampian and GGC, through the SPCRN’s research register. Practices were eligible for inclusion if they were medium-sized to large (four or more GP partners or a practice population of > 3500) and able to recruit two nurses who deliver annual reviews for patients with LTCs (DM – type 1 or 2, CHD or COPD). In addition, GGC practices were selected from the ‘Deep End’ cohort in order to compare practices in the most deprived city areas of Scotland with those in communities of more mixed affluence, which are generally smaller. Practices that had been approached in the focus group stage of the study were not approached in this stage.

The SPCRN initially issued e-mails, which included invitations and study information sheets, in batches of eight, to practices on their register that met the inclusion criteria. The first batch of invitations was sent to PMs in May 2015. The e-mails were followed up with telephone calls from the researchers to PMs to confirm receipt and interest in participating. If a PM did not recall receiving the invitation e-mail but expressed interest in the trial, the SPCRN was asked to resend the invitation either by e-mail or by post.

As there was insufficient interest from practices, a minor ethics amendment was made to permit direct contact with PNs and to include smaller practices with only one PN. Letter invitations were sent directly to PNs in practices already contacted (that had not yet declined) and to PNs in a further batch of practices. Researchers followed up the written invitations with telephone calls directly to PNs. Simultaneously, an open invitation to participate was issued in the Scottish Practice Nurse Association e-newsletter.

Following the completion of baseline recruitment, the five practices participating in both stages were randomised to the PCAM or CAU arms in a 2 : 1 ratio. This resulted in three practices being placed in the PCAM arm and two in the CAU arm for the second phase of research.

Patient recruitment

Participating PNs were each asked to identify up to 30 consecutive patients attending a review for one or more of the eligible LTCs, which were COPD, CHD and DM (type 1 or 2). PNs were able to exclude patients if the study was contraindicated as a result of a physical/mental health impairment or a cognitive or communication impairment, or if personal or family circumstances might have a serious impact on the patient’s physical or mental well-being. Potentially eligible patients could also be excluded if they did not attend the review and if NHS organisational or nursing time constraints interfered with the normal running of the clinics. PNs continued to recruit patients until they were informed by the research team that at least 10 questionnaires had been received or, in the later stages of the study, until data collection was terminated as a result of time constraints. This process was repeated with new patients post randomisation.

Outcome measures

Nurse-level outcomes were measured at the start of phase 1 and the end of phase 2 by:

• the number and range of referrals and signposting to GPs, repeat appointments with the PN and/or other services aligned with PCAM domains in the two stages of the trial, recorded on a nurse consultation form

• the DAQ24

• a bespoke questionnaire regarding confidence in asking about mental health issues.

Patient-level outcomes were measured by the:

• CARE measure23

• PEI22

• GHQ25

• WEMWBS27

• SF-12. 26

The questionnaire at the 8-week follow-up repeated these measures, with the exception of the CARE measure, and also asked patients whether or not they had taken up any signposting or referral advice, and their views on the outcomes of doing this or reasons for not taking these up.

Nurses also recorded demographic information about patients on the nurse consultation form, with postcodes being retained in the practice for collection by the SPCRN, which then matched these with Scottish Index of Multiple Deprivation (SIMD) code data and returned the SIMD codes matched to patient identification numbers to the research team.

Serious adverse events were monitored for each participant until the date of their follow-up.

Outcome data were summarised by descriptive analysis at baseline, at follow-up and, where relevant, between study arms. Continuous outcome data were assessed for ‘normality’, and parametric and non-parametric summary estimates were used, depending on the underlying data distributions. Data completion rates were estimated on demographics and outcome measures for each stage of the study. Change scores were estimated between arms, as to assess whether or not these were in the expected direction of effect; these are presented with their 95% CIs. No formal significance testing was done, as this study was not powered to detect differences between any groups.

Materials

Each participating PN was given a document case with 30 study packs, each marked with a unique patient identification number. Study packs contained a patient information pack, a patient questionnaire (with a prepaid envelope) and a nurse consultation form, all marked with the corresponding patient identification number. Standard operating procedures, a flow chart of the study process and a short suggested script for introducing the study to patients were also included in the document case. Post randomisation, study packs for practices in the PCAM arm of the trial also included a PCAM form in phase 2.

Practices randomised to the PCAM arm of the trial were also given a bespoke resources pack, containing contact names, brief information and numbers for local and national support organisations relating to the PCAM domains and to the specific LTCs. These were presented in an A4 slim file folder, with an index for the 8–10 pages of information. Space was also left for the practice to add any further resources. The pack was also made available electronically. See Appendix 5 for further information about the design and content of the resource packs.

Practice implementation of phase 1

Consenting PNs were given a 1-hour training session on the research processes and procedures. This included an explanation of the background to the PCAM approach and the current research study; an introduction to the standard operating procedures; a discussion on the practice’s preferred approach to patient recruitment; and administrative procedures. PMs or lead PNs were also invited to participate in this session.

Practices were asked to identify suitable recruitment periods. These could be either specific clinics, in which a number of patients with a particular condition were seen on the same day, or ad hoc review of patients during a specified period of time. Researchers offered to be present in the clinics on specified recruitment days to provide support to staff and to assist patients with questionnaire completion. This offer was accepted by all practices for the first recruitment session. Thereafter, this varied, with two practices requesting support throughout phase 1, while others had occasional visits to help with administration and address any issues.

Patient participant information

Ten nurses from six practices assessed a total of 329 patients in review consultations, of whom 113 and 77 participated in phases 1 and 2, respectively. Patients in phases 1 and 2 are different and are unpaired. Phase 1 is a baseline review of patient data prior to randomisation and phase 2; both phases had both pre- (baseline, T0) and post-intervention (follow-up, T1) data collection. Randomisation was to the PCAM arm (which included nurse training and nurse use of the PCAM tool and an accompanying resource pack) or the CAU arm.

Table 2 reports on the numbers of patient participants per practice. Only four of the six practices managed to complete phase 2 data collection (reasons for this are described in Chapter 7). This explains the reduced numbers of patient participants in phase 2. Some practices involved only one nurse (practices H and K), whereas others involved two nurses in data collection (practices E, F, G and J). Each nurse was asked to recruit 10 patients with completed questionnaires in each phase; this was achieved by all nurses in phase 1 and by six nurses in phase 2; however, only one nurse who participated in phase 2 failed to recruit the 10 patients required. This suggests that patient recruitment is achievable using the methods proposed in this feasibility trial. Some nurses recruited more than 10 patients, as their recruitment accumulated while patients delayed returning baseline questionnaires for a few weeks.

Table 3 shows the comparison of the patient participants in phase 1 with those in phase 2, and reveals small differences between the two samples. There was a higher proportion of males in both phases, and this increased slightly in phase 2. The sample was entirely/predominantly white in both phases. Slightly higher proportions of participants were in paid employment in phase 2, but slightly more also reported caring responsibilities. There were slightly more participants cohabiting and fewer living alone in phase 2, with more home owners and fewer participants reporting living in rented accommodation. It is not known whether or not the small differences in patient demographics are random, or if these are attributable to some bias in the nurse selection of patients to approach to take part.

Table 4 compares the characteristics of patients in phase 2 by randomisation group (PCAM vs. CAU). A total of 43 patients were recruited by the nurses in practices allocated to the PCAM arm, and 34 patients were recruited by nurses in practices allocated to deliver CAU. The randomised samples differed in their ratio of males to females, with a higher proportion of females in the PCAM arm. The PCAM arm participants were slightly better educated and more likely to be in paid employment, but also more likely to be living alone and in rented accommodation. The PCAM arm had, on average, much higher mean deprivation decile scores than the CAU arm, which means that PCAM arm participants were living in more affluent areas. This may have been attributable to high recruitment in one PCAM practice in a relatively affluent area.

Table 5 shows the self-reported health conditions of patients recruited to both phases. Although there are differences in the proportions having particular conditions, the overall levels of multimorbidity are similar across samples. Table 6 compares the same patient self-reported health conditions for patients in phase 2 by randomisation group (PCAM vs. CAU). There was a higher proportion of patients reporting higher levels of multimorbidity in the PCAM cohort.

Additional data on the SIMD for the sample are included in additional tables (see Appendix 6, Tables 10 and 11). Patient-reported outcome data (Appendix 6, Tables 13–19) are also presented. This feasibility study was not powered to detect any significant changes in outcomes; its purpose was to estimate data completion rates, including completion rates for different outcome measures. However, if possible, some indication of whether or not an outcome measure was likely to be able to detect any change as a result of the PCAM intervention was also of interest.

Patients were asked to self-complete questions that were similar to, or reflected the main domains of, the PCAM tool, to see how they might assess themselves in relation to biopsychosocial concerns: these data are reported in Appendix 6, Tables 12 and 13. Table 7 shows the patient-reported biopsychosocial concerns (reflecting the PCAM domains) for participants in both phase 1 and phase 2, and Table 8 shows the same data for participants in phase 2 by randomisation group of PCAM or CAU. Data completion for these sets of questions was around 94%. Participants were most concerned about their health, followed by their lifestyle and their finances. Problems with daily activities and concerns about their social networks were also reported. Participants recruited by nurses in practices allocated to the PCAM arm had higher levels of concerns about daily activities, social networks and finances. However, as these data were collected after their annual review using the PCAM tool, the patients’ perceptions of their problems may have been affected by the discussion.

In Appendix 6, Tables 14 and 15 show patient-reported outcomes from the CARE measure, which rates patient perceptions of health-care professional’s empathy during consultations. There were no apparent differences across phases or between PCAM and CAU cohorts.

In Appendix 6, Tables 16 and 17 report on the WEMWBS, PEI and GHQ patient-reported outcomes. The percentages of participants completing follow-up outcome measures in phase 2 T1 are reduced because of the dropout rate of practice E. There was no apparent difference between measures on rates of completion. Although the study was not powered to observe any differences in outcomes, Table 17 in Appendix 6 presents an analysis of the outcome scores by randomised group. On the WEMWBS, the scores show a small reduction at follow-up (indicating worse mental well-being), but these are further reduced in the CAU arm. On the PEI, in which scores were also reduced in both trial arms, there was also a larger reduction observed in the CAU arm. On the GHQ, in which reduced scores indicate an improvement in psychological morbidity, reductions were observed in both trial arms, with a larger reduction being observed in the PCAM arm. This might only very tentatively indicate that the PCAM tool might be likely to achieve more positive outcomes for patients than CAU, but this would require further testing on a larger sample.

In Appendix 6, Tables 18 and 19 report on summary scores and subscales of the SF-12 for patient participants across phases and for phase 2 by randomised group. There were no differences observed between participants in phases 1 and 2, and no differences between PCAM and CAU cohorts from baseline to follow-up.

Nurse participation information

In total, 10 nurses provided data (Table 7), of whom seven participated from practices E, F, G and H in both phases, and had paired data available to summarise (Table 8). Practices E, G and J were randomised to the PCAM arm, and practices F and H were randomised to CAU. Practice K was enrolled but not randomised, and no phase 2 data were available. Practice J was enrolled, with two nurses recruited; however, no nurse data were provided.

Nurse demographic and professional experience data were collected to indicate feasibility of data collection, and to test heterogeneity, which would affect a full trial. Table 8 shows the demographics of the nurse participants. Nurses in both arms were of a similar age group and sex (mostly female). The CAU nurses had been qualified for slightly longer, and those in the PCAM arm were more likely to have had some training in mental health in the past 5 years. Most nurses had used the Hospital Anxiety and Depression Scale (HADS) or the Patient Health Questionnaire – 9 (PHQ-9) depression screening tools.

Additional nurse outcome data are presented Appendix 6, Tables 20–25, comparing nurses by randomisation group: PCAM versus CAU; however, numbers are too small to draw any conclusions from these data beyond completion rates. In Appendix 6, Table 20 presents data on nurses’ responses to statements on how confident or skilled they felt in dealing with depression by randomisation group (PCAM versus CAU). Appendix 6, Table 21 presents data on nurses’ responses to statements on ‘the most effective treatment for depression is . . .’ by randomisation group (PCAM versus CAU) and Tables 22 and 23 in Appendix 6 present data on nurse confidence in raising and dealing with mental health issues and nurse confidence in raising and dealing with social issues, respectively. In these respects, the data show some slight improvements in nurses in the PCAM arm compared with the CAU nurses. This is the only discernible finding from these nurse outcome data. Table 24 in Appendix 6 presents nurse responses to questions about their perceptions of the care they deliver to patients and how patient centred they feel they are. Finally, Table 25 in Appendix 6, presents nurse responses to the DAQ.

Introduction

This observational study, embedded within the wider PCAM study, used audio-recordings of PNs’ reviews with patients with LTCs to gather data to assess how nurses use the PCAM tool and whether or not their practice had changed, following training in using the PCAM approach.

Sample and recruitment

All eight PNs participating in the study were invited to give consent to two or three consultations per nurse being recorded, both before and after PCAM training was completed, if the practice was randomised to the PCAM intervention group. Following completion of baseline data collection, each of these nurses was asked to approach up to five consecutive patients before and after the PCAM training to invite them to have their consultation audio-recorded.

Data collection

A digital audio-recorder was placed in the consulting room by the PN before each consultation, in a position adjacent to where the majority of the discussion would be taking place, but also where it would allow data from discussions in other areas of the room to be recorded. Patients were offered a letter of invitation and an information pack on the study by the PN before being asked to give informed consent. The nurse allocated each recording a unique identification number, which was also given to the patient in case they wished to withdraw consent. Patients were informed that they could withdraw consent to the use of the recording at any time. Nurses noted the patient’s participant number and their own identification number at the start of the recording. Nurses were asked to follow standard operating procedures, including noting the time of any breaks in the recording and when it resumed, if appropriate. A researcher collected the recorders from the practice either when recordings were completed or when the time allocated for this stage came to an end. Recordings were transcribed and anonymised.

Data analysis

Each audio-recording was listened to by two researchers, and analysed to note the time point when conversation segments relating to each PCAM domain appeared in the consultation. Any disagreements were discussed and consensus reached. Timelines of the sequence in which each domain appeared in each consultation were then constructed and used to compare the order and frequency of their occurrence before and after training in the use of the PCAM tool. The content of the discussions on mental well-being, social environment and health literacy was further analysed by two researchers to assess any changes in questioning styles or depth of exploration and consensus reached on any disagreement in interpretation. The range of lifestyle behaviours and social circumstances discussed was also considered. Non-specific greetings and enquiries (e.g. ‘How are you?’) were coded as ‘general’.

Findings

Four of the six nurses randomised to the PCAM arm agreed to do the audio-recordings. Two nurses recruited two patients at each stage, but, of the remaining two nurses, only one recruited a single patient within the time frame given for this stage of the study, giving a sample of nine patients (five before and four after PCAM introduction).

Nurses approached only a small number of patients, but then reported that all patients who were approached agreed to participate. Patients ranged in age from 55 to 84 years, with a mean age of 72 years. Five patients were male and four patients were female.

Figures 8 and 9 present the pre- and post-consultation content and timeline analyses. Blocks represent the start of a discussion rather than the duration.

FIGURE 8.

Pretraining consultation content and timeline analysis. The following key describes the content of each consultation segment that relates to the PCAM domains: DA, daily activities; Gen, general; HE, home environment; HL, health literacy; LB, lifestyle behaviour; MW, mental well-being; OS, other services; PH, physical health and SN, social network.

FIGURE 9.

Post-training consultation content and timeline analysis. The following key describes the content of each consultation segment that relates to the PCAM domains: DA, daily activities; Gen, general; HE, home environment; HL, health literacy; LB, lifestyle behaviour; MW, mental well-being; OS, other services; PH, physical health and SN, social network.

Sample and recruitment

Procedure

Nurses and other practice staff were interviewed by a member of the research team who had not been involved in supporting them during the data collection phase. Interviews were conducted by telephone and were audio-recorded. The audio-recording was unsuccessful for one interview, and for this interview, written notes were used to summarise the key points made.

Practice nurses and staff were asked for their views on the importance of psychosocial issues to their patients’ health and well-being, along with the relevance of assessing these in a nurse-led LTC review. The experience of taking part in the training, and whether or not it adequately explained the purpose of the PCAM tool and prepared staff for its implementation, was explored, along with a discussion of perceptions of using the PCAM tool. Reasons for taking part in the study, views on whether or not the PCAM was an appropriate tool for nurse-led annual reviews and how the tool was used in a typical consultation were considered. Support within the practice and any impact on patient interaction and assessment of patient needs, particularly mental well-being, were discussed, as well as perceptions and use of the resource pack. The integration of the resource pack and other PCAM-related issues with normal clinical practices were also explored. Future use of the PCAM and factors that would be needed for its widespread use were considered. Throughout the discussion, any barriers and facilitators encountered were probed.

Interviews with patients considered issues that were discussed in their consultation, and whether or not they were aware that the nurse was using the PCAM tool. Patients were asked about their awareness of nurse attention to wider aspects of their overall well-being, and what their views were on this wider discussion. Patients were also asked if they had received any health promotion and lifestyle advice or had been referred or signposted to other services. Their views on any referrals or advice offered were sought.

Patient perception of the Patient Centred Assessment Method

Not all patient participants in this sample noticed any overtly discernible difference in their annual review post PCAM implementation. However, some patients did report being asked more questions or finding out more about their health condition. Given that the PCAM tool is not a survey, or something administered to patients, it was not necessarily expected that the patients would notice the presence of the PCAM itself; however, patients did describe talking with their nurse about their lives and their broader concerns during reviews, and described welcoming these conversations with their nurse. Participants also described feeling listened to and feeling that the nurse was trying to address the concerns raised by the patient:

And I do remember that the time before I was quite upset because it was . . . it was just about a year to when my husband died and things were just making me upset. So we talked quite a bit in June about how I was feeling compared to the time before and she listened quite a lot to me and asked if she could do anything more for me because she thought maybe if I went to see a dietitian, but I couldn’t fit a dietitian into my life just now [laugh]! So she was trying hard to try and help with the problems that she thought I was having.

Patient interview, participant 422

Patient participants described the consultations as being conversational in style. This confirms that the PCAM tool was implemented as intended, as a guide for conversations with patients rather than as a tick-box tool:

Yeah. it’s more as a chat than, you know, sort of ticking a box, you know, she more sort of generally just chats and tries to get you to communicate.

Patient interview, participant 449

Because the PCAM tool is delivered conversationally, participants were asked how they felt about being asked questions about the broader context of their lives within the review. Overall, participants seemed happy to be asked questions, and the questions had helped participants to share some of the challenges and struggles they were facing in their lives with their nurse:

It doesn’t bother me, I’m quite happy to answer any questions like that. I mean, I had a difficult time when my husband died because he didn’t have enough insurance and it was something that had never crossed our minds, I don’t know why, I mean, we are, we were older, . . . so it just never crossed our minds. I have insurance as well so since then I’ve actually looked to see I have enough to cover [laugh], so things like that. Yeah, I wouldn’t hide anything from any questions that she asked, I’d be quite truthful in answering questions and that.

Patient interview, participant 422

Participants talked about trusting that their nurse would have a reason behind the questions they asked, and that it helped to promote a good relationship with the nurse when there was an opportunity to talk more broadly about their lives. Some described feeling that, if the nurse felt that it was relevant to their care to ask a broader question about their lives, it would be acceptable to them:

I think she could basically ask anything she wants if she thinks it’s relevant and it may have an effect on people, it must have an effect on people.

Patient interview, participant 449

Once information was shared with the nurse, patient participants talked about appreciating being given information or resources to help with addressing those concerns. Examples of information shared with patients included referrals to clinics for additional services, information about walking groups and referrals to dietitians. Not all participants felt that they wanted to act on these referrals at that point in time, but described appreciating having the option available to them. One patient participant described sharing their concerns with the nurse as beneficial in its own right, regardless of whether or not they proceeded to access the support suggested by the nurse:

But yes, in a way it is very nice to chat with somebody, even if they just want to talk about your health or a health problem or something, that alone can make you feel better I think.

Patient interview, participant 457

In summary, PCAM implementation did not have a negative or obstructive impact on the consultation. The use of the PCAM tool to guide the consultation appeared to be seamlessly integrated into the consultation from the patient’s point of view.

Nurse perception of the Patient Centred Assessment Method

Nurse participants had a very different experience of using the PCAM tool in consultations, as it was integrating a new approach to consultations for them. So while patient participants were generally unaware of the influence of the PCAM, the nurse participants were able to describe their experience of the PCAM in greater detail.

From feasibility to full-scale trial: using the ADePT decision aid to help identify protocol changes

The true value of any feasibility study is to identify and/or address any threats to internal or external validity that may have an impact on a full-scale trial. However, very few feasibility studies assess this in any systematic way. We chose to reflect on our study and its process evaluation with reference to ADePT,51 to identify protocol modifications for a full-scale study. The ADePT algorithm seeks to encourage systematic identification and appraisal of problems and potential solutions, improve transparency of decision-making processes and reveal tensions that exist between choices that lead to a pragmatic versus explanatory trial. The algorithm draws on Shanyinde et al. ’s framework50 of 14 questions for feasibility/pilot studies to consider (Box 1).

We identified the following areas as relevant to this feasibility trial: sample size, eligibility, recruitment, consent, randomisation, adherence/fidelity of intervention, acceptability of intervention, selection of appropriate outcomes, completion of outcomes, retention and logistics of multicentre sites and whether or not all components of the protocol worked. In evaluating the feasibility trial and its methods, several of the methodological issues identified by Shanyinde50 have been addressed elsewhere. Chapter 4 has addressed the quantitative findings in relation to sample, eligibility, recruitment, consent, randomisation and outcomes; Chapter 5 has addressed some aspects of adherence and fidelity to the PCAM intervention; and Chapters 3 and 6 have explored the acceptability of the PCAM intervention. The following analysis will focus on:

• retention

• study logistics in the multicentre sites

• where any adaptations to protocol were identified

• any unintended consequences

• whether or not components of the protocol worked together.

We then reflect on any identified issues using the ADePT algorithm to ‘problem solve’ and evaluate solutions for both trial and ‘real-world’ contexts. ADePT encourages assessment of problems into the following ‘problem types’: type A is an issue likely only to be a problem for the trial (unlikely to be a problem in the real world); type B is an issue likely to be a problem for both the trial and the real world; and type C is an issue likely only to be a problem for the real world. Solutions are developed in line with whether or not there is a need to change aspects of the intervention, the trial design or the context. Solutions (single or multiple) can then be reflected on for the likelihood of their feasibility or effectiveness in a trial and/or the real world (depending on the type of problem).

Implementation of the Patient Centred Assessment Method in primary care nurse consultations for long-term conditions

Key learning for implementation of the Patient Centred Assessment Method

Implementation of the feasibility trial

This analysis will focus on retention and study logistics in the multicentre sites and where any adaptations to protocol were identified.

Key learning

Some basic research principles may need to be included in trial processes training, especially explaining reasons for research processes in order to avoid selection bias in patient recruitment. There may be merit in the development of a short training session on research processes that could contribute to nurses’ continuing professional development training.

The PM role can be very important in helping to facilitate patient recruitment processes, especially for establishing practice processes for identifying ‘consecutive patients’, or temporarily changing practice processes to accommodate study requirements. Early trial discussions should include the PM, and practice-specific standard operating procedures could be agreed with PMs. PMs could help with the following processes:

• grouping appointments for specific days to facilitate researcher attendance on recruitment days

• allocating extra time for recruitment clinics, especially during the PCAM stage

• addressing PN concerns where they can

• making arrangements for patient information packs to be given out within the practice, by either reception staff or nurses

• flagging potentially eligible PCAM patients in PNs’ daily list.

Researcher support of data collection in practices is needed for both phase 1 and 2 data collection, at least for the initial few days. There is a need for a system of administrative data review in the early stages of the process with a researcher present, and throughout the recruitment phase, to ensure that protocols are adhered to. However, because of the ad hoc nature of booking LTC annual reviews in some practices, there is a conflict between being able to provide support for the research process and conducting research within budget constraints.

There is a need to establish particular times when other issues/seasonal workloads may make the implementation of the study difficult.

Further research is required to explore PN reluctance to audio-record their consultations and how this might be overcome in future fidelity studies, or indeed, other studies of the work of primary care nurses in managing LTCs.

Review of problems and solutions using the ADePT

Table 9 below sets out the problems identified within this feasibility study, the proposed solutions to these problems and an evaluation of the proposed solutions based on the AdePT decision aid.

Other initiatives to promote care co-ordination for people with long-term conditions

The HoC60 is a system-wide approach to improving care for people with LTCs. This initiative has been rolled out in NHS England and now also in Scotland. Figure 10 is a composite of models used to describe the HoC. The key approach of the HoC is to enable grass roots localities to build and develop their own ‘houses’ collaboratively with people and local communities. It requires enthusiastic clinical leadership supported by administrators and policy-makers. It is an approach that aligns with locality working and with health and social integration.

FIGURE 10.

A composite version of the HoC model.

However, it is not clear what this means for practitioners at the level of the consultation and face-to-face interactions, other than that these should encompass patient-centred co-ordinated care. The HoC relies on many parts of the system (of health and social care professionals) working together, and it is less clear how non-medical support (formal and informal) will be included and accessed within the consultation to support patient self-management and address other identified needs.

There was one practice in our study that was involved in HoC Scotland and, although this was seen as complementary to the PCAM study, the PNs reported that, for them, the PCAM had more relevance for influencing their direct patient care interactions and they ‘preferred’ to work with the PCAM going forward to address the needs of patients with LTCs.

The Links Worker Programme61 in Scotland is a Scottish Government-funded programme aiming to mitigate the impact of the social determinants of health in people who live in areas of high socioeconomic deprivation. Its basis is the inclusion of a new specialist role, the community links worker, in primary care teams. Links workers have a third-sector or community development background and work with patients to identify goals that they want to achieve, and then facilitate links with resources or organisations which can help to support patients’ needs and goals. They undertake some of the signposting and community referral tasks that the PCAM was asking of primary care nurses, but can go further in facilitating access for patients to these suggested signposting or referral options. Similarly to the goals of nurse use of the PCAM with patients, the rationale for links workers is that, if individuals feel supported in their lives, then they are more likely to respond to information on ways to improve their health and to live well. If these people were to be successfully supported sooner rather than later, then there is a potential that their risk of developing LTCs would be reduced, or further complications delayed or prevented if they have already contracted long-term illness(es).

The PCAM is probably most similar to the Links Worker model in its aims. The Links Worker Programme commenced during the PCAM study and its evaluation is still under way. Therefore, the evidence base for the Links Worker Programme is still unclear. However, there is still a need in primary care for nurses (and GPs) who see the majority of patients with LTCs to be able to feel confident in determining whether or not patients have any problems that could be dealt with by the links worker. The completion of the PCAM tool in annual reviews could act as a facilitator for referral to those in links worker-type roles, who could then facilitate access to community-based resources. The two initiatives are more compatible than incompatible, and could strengthen the identification of needs and communication between the primary care team and the links worker. It is also unclear who will fund, and whether or not they will fund, the continuation of the links worker roles in Scotland, and these are not available across the UK. Therefore, the PCAM may still be the best method available for the promotion of biopsychosocial assessment in primary care and, with the development of a locally derived resource pack, could also be the best-available method for facilitating access to a broader range of psychosocial supports.

In conclusion, we believe that the PCAM is uniquely developed for primary care and we are not aware of directly comparable assessment tools that have been prepared for and tested in primary care.

The PCAM provides a comprehensive and practical approach via the three components of training, the PCAM tool and the resource toolkit. Other initiatives like HoC lack an easily understood and easy-to-use practical tool. The use of the PCAM by primary care nurses as a decision aid for referral to links-type roles in primary care would work really well. Links-type roles could also make use of the PCAM itself. The PCAM could serve as a systematic way of recording needs and actions to be shared across the primary care team (GPs, nurses, links or other social care roles).

My experience and comments on the Patient Centred Assessment Method process; by patient representative 1

As a patient representative I appreciate the requirement and desirability for academia to be sometimes balanced by a lay point of view and if not present the journey from concept to publication may not be as comprehensive as it could be.

I sit as a patient representative (I prefer the term representative patient) on several committees and research groups so feel qualified to state that my experience with this feasibility study was one of the best in terms of support, inclusiveness, consideration and birthday cakes.

The panel made an effort to explain any terms or acronyms I or my fellow PR [patient representative] were unfamiliar with and always listened to our viewpoints and took the time to solicit our thoughts.

As to the actual content of the study I share the disappointment on the paucity of the total numbers of patients and practices involved but strongly believe that this holistic approach will show many benefits.

My particular thanks must go to Professor Maxwell, Dr Carina Hibberd and Ms Nadine Dougall.

My experience and comments on the Patient Centred Assessment Method process; by patient representative 2

As a sufferer from a sluggish (not to say absent) NHS protocol in dealing with anxiety issues caused by the diagnosis of a cardiac problem, I joined the Living Better Project Steering Committee which was an RCGP-led study aiming to improve the care of people with LTCs in primary care, hoping for procedural improvement . Unfortunately the results of the research resulting from the Living Better project did not translate into the hoped for improved protocol to establish a route to identify co-lateral problems which frequently resulted alongside a chronic disease diagnosis. But, in PCAM, I saw an opportunity to introduce a method to improve this situation within the existing structure.

Encouraged to be involved from the start in discussing the initial documentation and to join the Steering Committee by the key researchers it has been a pleasure to be involved with and to follow the development of this ambitious project. Always encouraged to participate fully in committee discussions and to contribute ideas throughout, and to feel free to criticise, my lay colleague and I were kept involved in all of the developing problems by the project leaders as well as in the successes. Our involvement in the discussion of the final report has also been thorough.

The infectious enthusiasm of the researchers and their stoicism when things were difficult have been singular.

There is no doubt in my mind that, in PCAM, there is the germ of an idea which will become part of NHS protocol in the years to come.

Adaptations

Initially, the training was developed as a half-day meeting with a brief face-to-face follow-up after nurses had practised using the PCAM tool with 10 patients.

However, after the first session it became apparent that nurses:

• would be unlikely to be able to dedicate a full unbroken half-day

• may benefit from focusing the evidence further on their own experience

• may benefit from time to reflect on the evidence and the PCAM introduction, and some distance in time before trying to integrate it into their practice.

In order to respond to this, the training was adapted over the course of the study:

• advance creation and sending of three case studies each

• 2.5-hour information session

• 1.5-hour self-study and reflection with resources

• 1.5-hour face-to-face practical session with a researcher

• self-reflective practice with 10 patients

• quick review with researcher (face-to-face or telephone).

The PCAM resource packs were organised in discrete sections based on the PCAM domains, with relevant service areas included for each domain:

• health and well-being: physical health support

  • allied health professionals

  • smoking cessation

  • addiction services

  • NHS weight management service

• health and well-being: mental well-being and social isolation support

  • mental well-being national resources

  • mental well-being local resources

  • voluntary befriending services

• health and well-being: lifestyle/social activities

  • physical activities

  • social activities

  • weight management support

• social environment/employment, care and support

  • money, employment, debt and benefit advice

  • domestic abuse services

  • carer support

• social environment/housing and home safety

  • housing and home safety

  • transport services

• health literacy and communication

  • literacy support

  • English for speakers of other languages

  • culturally sensitive support

  • support for sensory impairments.

An additional two sections comprised information relating to:

1. condition-specific support

   • COPD

   • CHD

   • DM

2. useful websites for further information.

Within each section, information comprised national resources [e.g. nationally available resources such as Citizens Advice or A Local Information System for Scotland (ALISS) database] and local or regional resources specific to each GP practice location.

Information about each resource comprised:

• name of resource (e.g. group/organisation/website title)

• short description of resource

• geographic area covered

• resource telephone/e-mail

• website address (as appropriate)

• opening hours (as appropriate)

• contact name (If available).

Each section was printed on plain white paper and placed together in clip file with a front index for ease of use.

To make the pack usable for nurses, the lists of resources were not exhaustive, but were targeted. In addition, the low-technology approach was somewhat influenced by the feasibility nature of the research, but was appreciated by nurses.

Copies of example resource packs are available on request from: pcam@stir.ac.uk.

What is a Patient Centred Assessment Method resource pack?

A list of local, regional or national groups/organisations/information sources for use by PNs as potential signposting/referral opportunities for patients with LTCs taking part in the PCAM study (intervention only).

Purpose of the resource pack

To aid PNs’ signposting and referral of patients to other professionals or organisations.

Design principles

• Reference was to be made to ALISS, which is a search and collaboration resource tool for health and well-being resources in Scotland. It is used to collect, organise and share links to community support. ALISS is funded by the Scottish Government and is delivered by the ALLIANCE.

• Referral and signposting opportunities presented within the resource packs were to be those covering psychosocial problems within the PCAM domains.

• PNs were to be a part of the design process by accessing their knowledge about the range of local supports available to patients.

• The format of the pack was aimed to make it as easy as possible for nurses to access and provide information for patients. Wherever possible, relevant leaflets were available.

Design stages

Preparation of the PCAM resource packs began following the randomisation of GP practices. Resource packs were prepared for only the three practices randomised to the intervention arm of the feasibility trial.

Following randomisation, two researchers were allocated the relevant GP practice locations for initial preparation of the resource packs.

Patient Centred Assessment Method resource packs: an evolving resource

During and after the PCAM training session, researchers talked through with PNs the ongoing, evolving nature of the resource packs and issues relating to keeping packs relevant and up to date. PNs expressed concerns about the time commitment that would be required to regularly update information. Researchers suggested that, perhaps, this was a role that could be adopted by a member of the wider GP practice team.

The compilation of the resource packs also provided potential for establishing broader relationships between GP practices and local community services. For example, the community learning and development service staff who met with the researcher in one of the GP practice areas indicated their interest in the PCAM tool and identified the potential for establishing closer links with the GP practice to share information about local services for patients. The researcher passed details of these staff on to the PM.