A psychological intervention by community pharmacies to prevent depression in adults with subthreshold depression and long-term conditions: the CHEMIST pilot RCT

Feasibility study

• To refine the bespoke enhanced support intervention (ESI) (including patient self-help materials, ESI manual and training) for implementation by CP staff to people with subthreshold depression and LTCs based on evidence-supported interventions in primary care.

• To develop and refine study procedures (CP set-up and recruitment strategies; participant screening, recruitment and assessment; suitability of outcome measures; and data collection procedures) for testing in the external pilot RCT. 42

External pilot randomised controlled trial

• To quantify the flow of participants (eligibility, recruitment and follow-up rates).

• To evaluate proposed recruitment, assessment and outcome measure collection.

• To examine the delivery of the ESI in a CP setting (ESI uptake, retention and dose) to inform the process evaluation.

• To conduct a process evaluation, using semistructured interviews with participants, pharmacy staff and GPs across a range of socioeconomic settings, to explore the acceptability of the ESI within the CP setting, elements of the ESI that were considered useful (or not), and the appropriateness of study procedures. 42

Feasibility study to external pilot randomised controlled trial

• Recruit five participants at each of four to six CPs by month 6.

• For 80% of participants to receive two or more ESI sessions within the 4-month post-recruitment period.

• Collect valid (intended) primary outcome measure on 80% of recruited participants at the 4-month post-recruitment follow-up.

• A fidelity score of ‘acceptable’ (3) or above to be achieved in at least 90% of assessed audio-recorded ESI sessions.

External pilot randomised controlled trial to a definitive randomised controlled trial

• Recruit and randomise 100 participants across five or six CPs by month 20.

• For 80% of participants randomised to the ESI to receive two or more ESI sessions within the 4-month post-randomisation period.

• Collect valid (intended) primary outcome measure on 80% of participants at the 4-month post-randomisation follow-up.

Inclusion criteria

To be eligible for inclusion in the feasibility study, participants needed to meet the following inclusion criteria:

• had subthreshold depression

• had at least one LTC

• were aged ≥ 18 years.

Subthreshold depression was defined as two to four symptoms of depression, at least one of which must be either low mood or loss of interest or pleasure on the major depressive episode module of the Mini International Neuropsychiatric Interview (MINI). 48

Long-term conditions were defined according to the Department of Health and Social Care definition:

. . . a condition that cannot, at present, be cured; but can be controlled by medication and other therapies.

Department of Health and Social Care. 49 Contains public sector information licensed under the Open Government Licence v3.0

Department of Health and Social Care, 2010.49 Contains public sector information licensed under the Open Government Licence v3.0).

The LTCs were those that were included in the NHS Quality and Outcomes Framework50 at the time of recruitment and included exemplar conditions, such as arthritis, cancer, cardiovascular conditions, diabetes, respiratory conditions, stroke and progressive conditions.

Exclusion criteria

People were ineligible for the study if they met any of the following exclusion criteria:

• had alcohol or drug dependence

• had cognitive impairment

• had bipolar disorder, psychosis or psychotic symptoms

• had active suicidal ideation

• were in receipt of psychological therapy.

Study information pack

Potentially eligible participants were given the opportunity to receive a study information pack (see Community pharmacy-based recruitment and General practice-based recruitment). This contained an invitation letter (printed on CP- or general practice-headed paper, as appropriate), a patient information sheet (PIS), a consent form, a background information sheet (see Report Supplementary Material 1) and a prepaid return envelope. The PIS advised interested CP customers/patients to complete and return the consent form and background information sheet to the study team in the prepaid envelope provided. They would then be contacted by the study team to discuss the study and to assess their suitability to take part.

Community pharmacy-based recruitment

Four methods of CP-based recruitment were employed during the feasibility study. All of the approaches were recorded (including the method of approach) on the customer’s patient medical record (PMR) to avoid duplication of approach via these recruitment methods.

General practice-based recruitment

General practices that were located nearby participating CPs conducted database searches on their systems to identify potentially eligible patients. Searches were restricted to patient postal codes within 2 miles of the participating CP(s) to ensure patient suitability of access, and included the exclusion criteria (see Participant eligibility). Lists of potentially eligible patients were reviewed by practice staff to exclude patients whom it would be inappropriate to invite. Practice staff then posted a study information pack to eligible patients.

Intervention name

The intervention was an ESI: a brief psychological intervention (BA) delivered within a collaborative care framework.

Rationale

The ESI was based on a collaborative care approach and involved BA as the core psychological component.

The CHEMIST ESI was adapted from existing training and intervention materials. These materials have undergone extensive development exploring the theoretical framework, acceptability and validity in previous multicentre RCTs. 38,56 The existing intervention and training materials were refined for use in CHEMIST to provide a focus on functioning in people with mental–physical multimorbidity. This was achieved through discussions with CHEMIST co-applicants, members of the research team and with a range of stakeholders (see Patient and public involvement).

Central to the ESI were CP staff (referred to as ‘ESI facilitators’ hereafter; referred to as ‘Healthy Living Advisors’ in participant-facing information) who were trained to deliver the ESI with study participants. ESI facilitators were responsible for employing BA techniques to support study participants to work through a self-help workbook and for proactively following up with participants, monitoring depression symptoms and facilitating communication with other members of the participant’s health-care team to ensure synergy with any current care being provided. These key elements of the ESI are described in the following sections. This approach is responsive to individual patient needs and fits the core elements of BA and collaborative care (see the following sections).

Materials and procedures

Study participants received a 28-page self-help workbook that was divided into eight stages (‘stages to keeping well’). The stages covered recognising symptoms of low mood/depression, diary-keeping, defining activity types, breaking activities down, identifying benefits of activities, identifying ways to be active, spotting symptoms of depression and setting an action plan. The workbook also included a number of tasks for participants to complete (e.g. making a list of activities that keeps the person well). A notes section was included at the end of the workbook, and participants were provided with additional copies of the diary and task pages. The workbook was used during and between contacts with the ESI facilitator. Participants were also provided with a blank copy of the DASS for use during each session.

The ESI was supported by a detailed ESI facilitator manual that included an outline of the key elements of the ESI, detailed session-by-session content, the DASS and the risk protocol (see Risk management). The ESI facilitator manual was supplemented by participant treatment logs, in which session information (e.g. scores on DASS, outcome of risk assessment and general session notes) was recorded for each participant and used to guide clinical supervision.

The CHEMIST ESI and training materials are not currently available outside the context of the study.

Enhanced support intervention facilitators were provided with information about study participants via the study team (following randomisation in the pilot RCT; see Chapter 6). The assigned ESI facilitator would contact the participant to arrange their first intervention session (to take place face to face in the pharmacy consultation room or over the telephone). Subsequent sessions were arranged during the previous session. Participants were encouraged to contact their ESI facilitator if they were unable to attend sessions so that these could be rearranged. ESI facilitators were advised to proactively contact participants who did not attend prearranged sessions. Contacts were monitored during clinical supervision.

Enhanced support intervention sessions followed a schedule outlined in the ESI facilitator manual. Each session involved a discussion between the participant and the ESI facilitator based on the stages within the self-help workbook. The first session included discussing how the participants were, including how they felt physically and mentally. Information was gathered on how the participant’s activities were being affected by their mood or physical health, as well as their understanding of the self-help workbook. Subsequent sessions began by gathering information related to the participant’s understanding of the previous session, discussion of the work undertaken since the previous session and reflection in relation to the BA approach. Opportunities to collaborate with health-care or social care professionals and voluntary sector organisations were identified and discussed. Support to access such services was provided if the participant wished. The DASS was administered during all sessions to monitor depression symptoms and the outcome was discussed. Potential risk was checked at the beginning of all sessions and the risk protocol was activated if necessary (see Risk management). Finally, the next stage(s) of the self-help workbook was discussed and the ESI facilitator and participant agreed the work to be undertaken before the next session.

Intervention providers

The CP pharmacist and/or pharmacy manager identified and approached suitable CP support staff about the study and the ESI facilitator role. ESI facilitators were CP support staff experienced in the delivery of pharmacy extended roles (such as smoking cessation behavioural–change approaches) and/or training to Royal Society of Public Health standards (Understanding Health Improvement Level 2).

Enhanced support intervention facilitators attended a 2-day training workshop prior to delivering the ESI. The workshop included presentations (copies of presentation slides were provided) that outlined the study and explained the concepts of BA and collaborative care. Clinical scenarios were used to outline the ESI rationale and process. The materials to be used as part of the ESI (patient self-help workbook, ESI facilitator manual and participant treatment logs) were provided and described. Clinical role-play exercises were used to practise skills and ESI session content based around the self-help workbook. Opportunities were provided to discuss the ESI and the role-play exercises. The workshop also included training on risk assessment (with opportunities to practise this via role-play) and other important study procedures [including serious adverse event (SAE) reporting and participant withdrawal]. ESI facilitators were required to undertake and pass a telephone-based competency assessment before they could be assigned an ESI participant.

Enhanced support intervention facilitators received telephone supervision from a clinical member of the research team on a session-by-session basis.

Mode of delivery

The ESI was designed to be delivered on a one-to-one basis by a combination of face-to-face and telephone contact (based on participant preference). Participants were offered the first session as a face-to-face contact within the CP, with telephone delivery encouraged for subsequent sessions.

Location

The ESI was delivered via CPs located in the north of England.

Personalisation

Although all participants received the same self-help workbook, the ESI was designed to be personalised by the ESI facilitator to the participant’s situation and long-term health problems using the self-help workbook as a guide.

Intervention dose

The ESI was designed to be between four and six sessions, delivered where feasible on a weekly basis over a period of up to 4 months. The first session was designed to take up to 60 minutes, with subsequent sessions taking between 20 and 30 minutes.

Modifications

The ESI was adapted from existing intervention and training materials. The ESI was not modified during the course of the feasibility study. Modifications were made following the feasibility study in advance of the pilot RCT; these modifications are reported and described in Chapters 5 and 6.

Competency and intervention fidelity

The competency of ESI facilitators to deliver the ESI in line with training and the ESI facilitator manual was assessed using procedures adapted from previous related studies. 61 Following the ESI training workshop, mock telephone ESI sessions were conducted with ESI facilitators, and behaviours and performance were evaluated against a competency checklist. ESI facilitators were offered additional training, if necessary, to enable them to achieve the required standard to pass the competency assessment.

Fidelity to the ESI was supported by the ESI facilitator manual, which included ESI session guides. Telephone supervision was offered by clinical members of the research team after every ESI session. ESI facilitators also had access to ad hoc telephone supervision if they required further support. Fidelity assessment also involved obtaining audio-recordings of ESI sessions (where participant consent was provided for this). A random selection (10–20%) of audio-recordings across different phases of the ESI (early/late) was to be independently reviewed and assessed against a fidelity checklist. The feasibility of obtaining these audio-recordings was to be explored in the feasibility study, given that the delivery of the ESI to research participants was a new approach for CPs.

Intended primary outcome measure

The intended primary outcome measure was self-reported depression severity at the 4-month follow-up, as measured by the Patient Health Questionnaire-9 (PHQ-9). 63 The PHQ-9 is widely used in clinical and research settings and has good sensitivity and specificity in a UK population. 64

Intended secondary outcome measures

• Self-reported binary depression severity (PHQ-9),63 using a score ≥ 10 to indicate moderate depression caseness at the 4-month follow-up (thus providing a measure of the potential preventative aspects of the intervention in their ability to prevent progression of depression).

• Anxiety [Generalised Anxiety Disorder-7 (GAD-7) scale]. 65

• Physical/somatic health problems (PHQ-15). 66

• Health-related quality of life [Short Form-12, version 2 (SF-12v2)]. 67

• Health state utility [EuroQol-5 Dimensions, three-level version (EQ-5D-3L)]. 68

• Health and social services use collected via a bespoke resource use questionnaire.

Outcomes

In the feasibility study, the outcomes of interest were recruitment and retention rates, the quality of data collected and engagement with the ESI. The number of pharmacy customers/patients approached and the number of participants recruited and who completed the 4-month follow-up are detailed, along with the completeness of the standardised measures used. The number of ESI sessions attended and the number of participants who did and did not start the ESI sessions will be detailed, with reasons provided where possible.

Serious adverse event data were summarised descriptively by treatment arm.

Participants and recruitment

Analysis

The interviews and focus group were recorded using an encrypted digital audio-recorder and were professionally transcribed verbatim. All data were analysed thematically initially using constant comparison69 followed by a framework analysis46 using the TFA to sensitise the analysis. 47 Although it was initially intended that a secondary analysis using NPT45 would be undertaken, as the analysis progressed the TFA was felt to be more appropriate as this framework offers the opportunity to focus on acceptability of the ESI and ESI training, and what modifications are needed for the pilot RCT. The analyses were undertaken by a team of researchers with varying professional backgrounds to increase the reliability of the analysis. 70 Regular coding and analysis meetings were held to ensure that the emerging themes remained grounded in the data, and that the TFA appropriately represented the data.

Recruitment

The target sample size for the feasibility study was 20–30 participants, who were to be recruited over 5 months (February to June 2017) from four to six CPs (see Chapter 1, Progression criteria).

A total of 24 participants were recruited to the study over a period of 9 months (April to December 2017) and from across a total of eight CPs, indicating that recruitment was slower than anticipated. Five CPs commenced recruitment in April 2017; however, owing to the observed slow recruitment, the recruitment period was extended (by 4 months) and three additional CPs were recruited to the study (from August 2017). One general practice conducted a database search and mailed out study information packs to eligible patients (eligible and recruited participants were associated with a single recruiting CP). Figure 1 shows a breakdown of recruitment over the 9-month recruitment period.

FIGURE 1.

Feasibility study: target and actual recruitment rates. Reproduced with permission from Chew-Graham et al. 75 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/. The figure includes minor additions and formatting changes to the original figure.

Reproduced with permission from Chew-Graham et al. 75 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/. The figure includes minor additions and formatting changes to the original figure.

Overall, 1082 study information packs were distributed: 882 packs via pharmacy-based recruitment methods (opportunistic approach within the CP, via home-delivered prescriptions and via pharmacy system searches) and 200 packs via GP-based recruitment methods. From this, 71 pharmacy customers/patients returned a consent form to the study team to indicate their interest in the study (6.6%), of whom 28 were eligible to participate in the study following eligibility screening (39.4% of the 71 screened) and 24 (85.7%) decided to take part in the study. Reasons for ineligibility can be found in Table 1, with the most common reason being either non-depressed (34.9%) or currently experiencing an episode of major depression (34.9%). Table 2 details the distribution of study information packs, returned consent forms and resultant screened and recruited participants. Recruitment activity by pharmacy is shown in Table 3.

The active recruitment period across CPs varied from 2.7 months to 7.2 months, with an average period of 5.5 months; however, it should be noted that the three pharmacies that were recruited part-way through the 9-month recruitment period were open to recruitment for a maximum period of 5 months. This gives an average recruitment rate of 0.55 participants per pharmacy per month. Rates of recruitment varied across the pharmacies, with the proportion of those participants screened who were subsequently recruited to the study ranging from 0 to 0.55 and with, on average, 30.3% of those screened participating in the study; Figure 2 details the screening and recruitment for each pharmacy. The flow of participants through the study is shown in the Consolidated Standards of Reporting Trials (CONSORT) flow diagram in Figure 3.

FIGURE 2.

Feasibility study: overall screening and recruitment per pharmacy. Reproduced with permission from Chew-Graham et al. 75 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/. The figure includes minor additions and formatting changes to the original figure.

Reproduced with permission from Chew-Graham et al. 75 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/. The figure includes minor additions and formatting changes to the original figure.

FIGURE 3.

Feasibility study: CONSORT flow diagram. a, Multiple reasons for exclusion may be given. Reproduced with permission from Chew-Graham et al. 75 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/. The figure includes minor additions and formatting changes to the original figure.

Reproduced with permission from Chew-Graham et al. 75 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/. The figure includes minor additions and formatting changes to the original figure.

Participant characteristics

Baseline data for the 24 recruited participants are detailed fully in Table 4. There were no missing data with respect to participant characteristics. The average age of the participants was 66.8 years, ranging from 51.3 years to 83.6 years. One-quarter of the participants were male and most (87.5%) responded positively to Whooley question 1 (‘During the last month, have you often been bothered by feeling down, depressed or hopeless?’) and to Whooley question 2 (‘During the past month, have you often been bothered by having little interest or pleasure in doing things?’) (95.8%). There was a wide variety of health problems, with the most common being high blood pressure (n = 16). All of the participants classified themselves as being of white ethnicity; it is noted that all of the recruiting CPs were located in the north-east of England, which has a largely white population. The majority of participants (n = 14) did not continue with education after the minimum school leaving age; however, six participants indicated that they had a degree or equivalent-level qualifications. See Table 6 for the baseline standardised measures alongside those at the 4-month follow-up.

Intervention delivery

All of the 24 participants were offered the ESI, of whom 17 (70.8%) commenced the ESI. Engagement with the ESI sessions is detailed in Table 5. In total, 10 out of the 17 participants completed all six sessions of the ESI (58.8%), with all those participants who commenced the ESI receiving at least three of the ESI sessions. A total of 91 ESI sessions were conducted, of a possible 102, giving an average completion of 86.1% for those who commenced the ESI.

A total of 17 ESI facilitators completed the ESI training as part of the feasibility study, and 13 were available to deliver the ESI during the intervention period, of whom nine supported at least one participant through the ESI. The average number of participants supported by an ESI facilitator was 1.9 participants (ranging from one to four participants).

All seven participants who did not start the ESI sessions withdrew from the ESI before the sessions commenced. Reasons (where known) for not commencing the ESI sessions included no longer feeling that the intervention was relevant, ill health, feeling better, the family feeling that the study was not suitable for the participant, and being unable to contact the participant to arrange ESI sessions.

Follow-up and withdrawal

Seven participants (29.2%) withdrew from the ESI before commencing the sessions (see Intervention delivery); of these, one participant withdrew fully from the study.

Twenty of the remaining 23 participants completed and returned a 4-month follow-up questionnaire, giving a return rate of 87.0%; this included five participants who did not commence the ESI. Overall, the retention rate for the feasibility study at 4 months was 83.3% (20 out of the 24 participants).

Standardised measures

A range of standardised measures were collected during the feasibility study (see Chapter 2) to assess for completeness and suitability for use in the pilot RCT. These measures included the PHQ-9, GAD-7 and Patient Health Questionnaire-15 (PHQ-15). 63,65,66 Scores for these measures at baseline and at the4-month follow-up can be found in Table 6.

Overall, the level of completion for these standardised measures in the feasibility study was excellent: 100% at baseline for all measures and between 95% and 100% at the 4-month follow-up (of those who returned the questionnaires). Although there is only a small sample of data, and for this reason no formal comparisons can be made, it does appear that the results change slightly between baseline and 4 months.

Although the intention had been for participants to complete the BADS during ESI sessions (see Chapter 2, Outcome measures), this measure was not administered during the feasibility study. In addition, additional information (relating to depression history) was also not obtained during the feasibility study. These data will be collected in the pilot RCT described in Chapters 6–10.

Competency and intervention fidelity

Of the 17 ESI facilitators who completed the ESI training, nine passed the competency assessment on the first attempt and, following additional telephone-based support, six passed on the second attempt and one on the third attempt (one ESI facilitator left the pharmacy before attempting the competency assessment). All ESI facilitators who went on to support participants through the ESI received session-by-session clinical supervision.

Although the intention was to audio-record ESI sessions (with participant consent) to assess fidelity to the ESI, the decision was made not to record these during the feasibility study. CHEMIST represented a new challenge for the recruiting CPs (the majority of which had no prior experience of research). Many of the ESI facilitators had limited experience of mental health, were new to working with the participant group (people with subthreshold depression and LTCs) and were engaging with new experiential training methods. The study team felt, on reflection, that asking ESI facilitators to record ESI sessions in addition to delivering the ESI within the setting of a CP would be an unfair burden on this group, and may risk ESI facilitator dropout. This decision was made in consultation with the wider study team, the CHEMIST stakeholders and the funder.

Although recordings of ESI sessions were not obtained, close monitoring of ESI delivery and adherence to the ESI manual took place (as originally planned). This was achieved through session-by-session clinical supervision at which the content and delivery of each ESI session was discussed, allowing the clinical supervisor to offer support and advice (to include adherence to the ESI manual) following each delivered ESI session. ESI facilitators were also required to complete a participant treatment log for each delivered ESI session, which was reviewed during each clinical supervision session.

Fidelity to the ESI would be examined in the pilot RCT, by which point it was anticipated that study processes would be more embedded in CPs and ESI facilitators would have increased confidence in these new training and assessment procedures. ESI facilitators would be advised of the need to audio-record sessions during the pilot RCT ESI training workshop.

Serious adverse events

There were no SAEs reported in the feasibility study.

Clinical results: summary

The feasibility study suggests that it is possible to recruit to the study; however, recruitment was much slower than anticipated, which highlights the novelty of conducting a mental health research study within a busy CP setting. The completeness of the outcome measures and the return rate of the questionnaires indicate that this patient population were willing to complete the questionnaires and were keen to stay active participants in the study. Equally, the high completeness (86.1%) of the ESI (for those participants who commenced the ESI) suggests that participants find the intervention acceptable and are willing to participate in the ESI sessions (see Chapter 4). This also suggests that CP staff can be successfully trained to deliver the ESI in a CP setting.

With respect to the predetermined criteria for progressing from the feasibility study to the pilot RCT (see Chapter 1) as follows:

• Recruit five participants at each of four to six CPs by month 6 – 24 participants were recruited across eight CPs over a 9-month recruitment period (the last participant was recruited in month 12).

• For 80% of participants to receive two or more ESI sessions within the 4-month post-recruitment period – 17 out of the 24 recruited participants (70.8%) received two or more ESI sessions (100% of those commencing the intervention) within the 4-month post-recruitment period. The remaining seven participants did not commence the ESI.

• Collect valid (intended) primary outcome measure on 80% of recruited participants at the 4-month post-recruitment follow-up – the retention rate was 83.3% at the 4-month post-recruitment follow-up, with 95% data completeness for the PHQ-9.

• A fidelity score of ‘acceptable’ (3) or above to be achieved in a least 90% of assessed audio-recorded ESI sessions – to be examined in the pilot RCT (see Competency and intervention delivery).

Interviews with participants and ESI facilitators conducted as part of the feasibility qualitative study will further explore the feasibility and acceptability of the study, ESI training and delivery, and study procedures (see Chapter 4).

Following discussions with the TSC and the funder, progression to the external pilot RCT was recommended.

Health services resource use

Health-related quality of life

Health-related quality-of-life data were collected using the EQ-5D73 and SF-12v267 questionnaires at baseline and at the 4-month follow-up.

Health economic results: summary

The economic analysis evaluated the overall response rates, the item completion rates and the range of values provided in response to the bespoke resource use questionnaire and quality-of-life (EQ-5D and SF-12v2) questionnaires. Both health service resource use and EQ-5D questionnaires had 100% completion rate among participants at baseline and at the 4-month follow-up. There were no missing items in either questionnaire. GP visits were the most common types of resource use items. Overall, the economic analysis suggested a high level of questionnaire completion rate, a low level of item missingness and no out of range responses.

Study participants

Eleven study participants were interviewed from five of the eight participating CPs. Nine study participants had completed between four and six ESI sessions (seven study participants had completed all six ESI sessions) and two study participants did not start the ESI sessions (ESI non-completers). All of the study participants were of white ethnicity. Table 11 provides demographic details for the interviewed study participants. Interviews with participants explored their experiences of receiving the ESI and their acceptability of the ESI.

Enhanced support intervention facilitators

A total of 17 ESI facilitators completed the ESI training as part of the feasibility study and 13 were available to deliver the ESI during the intervention period, of whom nine supported at least one participant through the ESI. Thirteen interviews were conducted with nine ESI facilitators from seven of the recruiting CPs (see Table 12). Four ESI facilitators completed two interviews (the first focused on their experiences of the ESI training and the second focused on their experience of delivering the ESI). Five ESI facilitators completed a single interview on their experiences of ESI training and delivery. Table 12 details the demographic details of the interviewed ESI facilitators.

Five pharmacy staff from three participating CPs participated in the focus group.

Intervention coherence

This construct assessed the extent to which the ESI participants understood the ESI and how it worked.

The identification of mood problems and the provision of subsequent support made sense to participants who received (‘intervention participants’) and delivered (‘ESI facilitators’) the ESI. Intervention participants and ESI facilitators acknowledged the link between physical and mental health and ill health:

I think they are linked. I think if somebody gets diagnosed with, whether it be asthma or diabetes, we, we initially think oh my goodness, how am I gonna cope with this? Some people are really strong and can cope with it and take it all on board, other people really struggle, and in that struggle it affects the day-to-day life of everything else, it’s not just the fact they’ve got diabetes, unfortunately it affects every aspect of their life.

ESI1

. . . it, I can’t do, there’s things that you can’t do; I can’t hold things in me right hand and; so it does get us depressed not being able to do what I want to do. Me colitis sometimes gets us depressed because if I’ve got a flare up I can’t go out the house, because I need to use the toilet all the time. Me COPD [chronic obstructive pulmonary disease], as long as I’m taking me inhalers I’m not too bad, you know. But yes, it definitely reflects on me mood, on me moods and things and, yeah.

P6

The ESI made sense to those who undertook it, with the intervention participants reflecting on the usefulness of the workbook, the structured nature of the ESI, the homework required of them and the benefits of the ESI to them as an individual:

Yes, it did [make sense]. It was particularly in the workbook, it mentioned things like can’t be bothered, not going out, making excuses; and I thought yes, that, that, that’s me, but I thought it was just getting older and, you know, not wanting to do things like that, so. That wa, that was, that was very useful.

P18

I thought, and I, I, perfectly honest, it has done me the world of good. It’s been therapeutic, because I was getting a regular call on a Wednesday, and I would work to that call on the Wednesday, because I was given a plan, I was given advice, keeping me diary, for example, on how I felt from day to day, planning to do tasks, even though they seemed insurmountable at times.

P49

The CP was seen as an appropriate and logical setting in which to deliver the ESI, with the location seen as familiar and non-stigmatising by both intervention participants and ESI facilitators:

We have a lotta people that come in and tend to, for whatever reason, see it, us in a pharmacy, as someone as a, who they can talk to openly and honestly.

ESI1

Perceived effectiveness

The TFA construct of perceived effectiveness describes the extent to which participants perceive that the intervention will achieve its purpose. 76

A number of aspects of the ESI were perceived as likely to achieve their purpose. Although some intervention participants disclosed initial uncertainty about the preliminary assessment, these feelings were quashed once the assessment had been undertaken:

Yeah, I thought it was a bit [sighs] a bit strange at first, and then when you read and understand what everybody’s trying to say and get to and get your answers from you, I think it, it’s done in a very sensitive way and I think it, it’s positive.

P14

The materials were thought to achieve their purpose; in particular, the patient workbook was well received by intervention participants and also by ESI facilitators who described working through them with the participants:

We went through it together. So she was like asking us the questions out the book that I already had, you know, so went through together. So yes, it was all right, I understood it, yeah.

P6

I thought that was fine, I just, I thought it made more sense once I got the self-help work book, everything, once I got that, I read this from beginning to end. So I didn’t even, you know, I, once I got this I thought oh so we’re gonna be doing this and gonna be doing that; but that’s the person I am. Some people might just do one stage as, at a time, I read the whole thing to see what it was gonna entail before; so I was well aware what I was going into, and if there was something I didn’t like I would have said; but I thought oh this is all right, seems all right to me. So, there you go.

P2

Intervention participants said that the activity planner in the workbook was particularly valuable:

I gave up filling the end part of the book up cos I thought what activities do yer like to keep, help yer keep well? There’s a lotta things that I could, I could be doing more, but that’s gonna come in time. I’m more worried about, I’m, was more interested in filling this chart to say, right, this is what I did.

P2

Very, yeah. Ess, essential in fact, cos that’s a whole part of the, the, the study, isn’t it, the kind of, help the, the patient, if you will, to use the book to help themselves. So yeah, very good, kind of well set out and easy to understand.

ESI6

Intervention participants reflected on the importance of confidentiality and trust in the ESI facilitator, which appeared to give them confidence to engage in the ESI and faith that it could produce a positive outcome or ‘good result’:

I know [the facilitator], I can speak to [her] and I know it’ll be confidential and it wouldn’t go any, any further, it wouldn’t go any further with any of the staff or anything like that, she would give me a good result and I would give her a good result . . .

P22

Self-efficacy

Enhanced support intervention facilitators expressed mixed views about whether or not they had developed the confidence to deliver the ESI following the ESI training. Notably, anxiety and uncertainty particularly focused around participant risk assessment:

. . . OK. I think one of the questions I would, I would find it quite awkward asking people where you had to just say have you thought about killing yerself in the last week; I think that might come across as, I don’t know what the word is, a bit blunt [laughs]. But yeah, apart from that . . .

ESI6

However, some ESI facilitators described how they gained confidence with increasing experience of ESI delivery:

I didn’t really find it difficult. I found, I did, at first, at first, when I first started, I thought asking the questions, the risk questions I’d asked be quite daunting and impersonal and whether they would be quite negative, but when we’ve done it on a regular basis I can see that there’s a need for it and you can see, especially with one, with one of them, even with the one that decided at 4 weeks, decided she didn’t want to go any further, it was a noticeable difference in the scores that it had improved, so at least there was some benefit. So with regards to that, I think it was quite OK, to be honest, I didn’t really have any problems with that.

ESI1 (second interview)

Intervention participants all described confidence in goal-setting, keeping diaries and being monitored by their ESI facilitator:

. . . in particular when we were talking about breaking activities down into smaller parts, because again me mobility has really restricted me with a lot of things, and even a simple thing like making the bed [laughs] you, you know, we used that as an ex, one, one example, and it was a case of not making it and changing the blankets all in one go and, you know, so we did it sort of like, you know, with [names ESI facilitator] help we, we broke that down into smaller steps.

P46

Not all intervention participants were confident that they could continue to practice what they had learned during their work with the ESI facilitators:

I think I try to now, yeah, I think on things a bit more. Whereas before I would just sit, now I try to get up and do something and I try to have a different outlook on, on the way it was to the way it is now, even though I’ve got the pressure of my wife it’s still, it’s still a bit different than what it was.

P14

However, other intervention participants described continued use of the BA techniques learned, including monitoring mood, and indeed their own adaptions to the study materials:

Having a mood chart but, I mean I’ve, I’m using me own calendar and I’m putting me score; so I just do, I just do morning and night, because morning I’m usually, nine times out of ten, I’m very high in a morning, because I like getting up, I’ll get up early, I do everything on a morning, so my mood’s quite high, it’s when I get, after work I’m tired. Obviously, it lowers and things like that, and at the minute it’s, it’s on about a 5 when I come back from work, cos when I come back from work I’m thinking about me sister, so. But it’ll, it’ll be like that, and I’m not worried about that being low when it’s been an 8 on the morning, because you haven’t had time to think, you know, things like that . . .

P2

Burden

Both ESI facilitators and intervention participants alluded to the burden that participating in the study entailed. For example, ESI facilitators described the challenge of discussing the study with pharmacy customers and specifically the difficulty of finding the words to describe the purpose of the study and the description of ‘mood’:

Like my big problem was how to initially say to people ‘do you want to participate?’, cos I didn’t want to say it’s about low mood or subthreshold depression, I just didn’t wanna mention those terms cos I just knew people would be put off. So I was like I need some key words to throw in here [laughs] and she said ‘Say it’s a psychological well-being study’. And as soon as she said that I was like, right, that’s much easier [laughs]. I approached a lot more people then, yeah.

ESI4

All ESI facilitators and pharmacy staff described some difficulty in fitting aspects of the study into their daily routine:

. . . it’s sort of 15/20 minutes taken off my time and I’m very needed on the shop floor. So, it means that somebody has to drop down, and then I feel like I’ve left two very capable dispensers having to cover a shop floor with a queue full of people, which sometimes I do feel guilty about.

ESI1 (second interview)

However, this ESI facilitator added:

But then when you think of the impact it’s gonna have on the customers that we see, it’s worthwhile doing; regardless of how many staff we’ve got on the counter, if we can help just one person it’s been worthwhile.

ESI1

In addition, the impact of the study, in particular the recruitment process, was echoed by the wider pharmacy staff in the participating CPs:

A bit, like you said, like it’s the, the, [facilitator] would have to go, she’d want to sit and prepare before somebody came in, to read the notes, to see where she was at. I think the first person that came in took about three-quarters of an hour and then, then there was the phone call with [names clinical supervisor] to then catch up; it just seemed to take a lotta time and I know, obviously I, there was another three pharmacies in my group, one of them didn’t do it because they do like 17,000, like 18,000 items, just don’t have time to do it, they said they just don’t have time to get the staff to go and give the packs out, never mind seeing people; and it’s, it’s unfortunately about money sometimes that they . . .

FG PS5

Despite the difficulties experienced, pharmacy staff were keen to stress the generalisability of the training and skills learned in being part of the study:

Yeah, and it’s expanded my knowledge, it’s made me aware to, to look for what’s in our community, not further afield, because people don’t want to travel, but to see what’s openly available. So now I’ve got a list of what’s openly available for people who are overweight or struggling with anything and; men’s football clubs for the over fifties, running clubs. I’ve been looking at everything so that if anybody says to me I need to do that, I’ve got a folder; and I would never have done that if it hadn’t have done the CHEMIST study.

ESI1 (second interview)

Descriptions of burden from intervention participants, however, were seen infrequently; rather, the sessions with the ESI facilitators were viewed positively:

In fact when she said when it was the last one I was quite disappointed really because it was becoming a regular on the Wednesday morning, you know, about an hour we would have talking together.

P49

A minority of intervention participants described how a lack of motivation affected their enthusiasm to attend ESI sessions:

. . . but it was just the, just the, just the mood I was in, I would say to [the facilitator] ‘I’ll come in tomorrow’. And then when the, the tomorrow come, I thought oh I, I really didn’t want to come, you know. but I did, I mean I did do it all, I finished it; took a bit of a while. But just, like I said, all depending; I mean today, the way my hand is, I, I found difficulty driving, to tell you the truth, ‘cos I had to drive with them two fingers. So there is times where I’ve got to push meself, otherwise I’m just in the house, you know. But, but yeah, I, I, I, I think it’s, like I say, I still come, but it was a bit difficult sometimes not wanting to come, so.

P6

Opportunity costs

The TFA domain of opportunity costs describes if benefits, profits or values need to be relinquished to engage in the intervention. 76

Discussion of opportunity costs was reported by ESI facilitators and pharmacy staff in terms of the time cost on regular pharmacy work as a result of the ESI facilitator delivering the ESI intervention:

So I think it’s got a big impact on the pharmacy, if you’re working in a busy pharmacy, ‘cos you’re taking somebody away for a good 30 minutes and then, which is a good hour, because then you have to call [supervisor] and then you go through the session with [supervisor]; so you’re talking about, sometimes that can be another 15/20 minutes, depends. So you’re taking like a, a body out of the pharmacy; so while that, while that’s getting done my work at the back’s not getting done.

FG PS1

Intervention participants did not feel that being involved in the study had any impact on their day-to-day activities (‘opportunity costs’), but one intervention participant acknowledged the difficulty of fully participating in the study owing to a recent bereavement:

But I can only do; and obviously with just losing me sister, everything’s gone a bit pear-shaped at the minute, but I can only do so much and it, it, it is what it is, but I will get there.

P2

Affective attitudes

The construct affective attitudes describes participants’ feelings about the intervention. 76

The ESI facilitators were generally known to the intervention participants and this appeared to be a key enabler of their positive feelings towards participating in the study and working with the ESI facilitator to complete the ESI:

. . . but knowing the pharmacy, this particular pharmacy as I do, I wasn’t surprised that they were interested in it.

P18

. . . I think a big part of it is like how the staff are with the patients, like you said you know your patients very well . . .

FG PS3

In addition, the personal qualities of the ESI facilitators were deemed to be important in relationship building and persisting with the ESI:

Oh great, absolutely great, great, because she’s [the facilitator] friendly, she’s approachable, you know what I mean, so; and I mean that, that’s what you need because it, it, some people can find it intimidating.

P2

No, no, I just, I really found [names ESI facilitator] to be very helpful, very understanding; there was one time, again it was me mobility, I couldn’t get to the chemist, she was quite happy to change the appointment, you know, and, and she was just really, really helpful.

P46

The training was valued not just to help in the delivery of the study, but to assist in their usual, routine work within the pharmacy:

Yeah, and it’s expanded my knowledge, it’s made me aware to, to look for what’s in our community, not further afield, because people don’t want to travel, but to see what’s openly available. So now I’ve got a list of what’s openly available for people who are overweight or struggling with anything and; men’s football clubs for the over fifties, running clubs. I’ve been looking at everything so that if anybody says to me I need to do that, I’ve got a folder; and I would never have done that if it hadn’t have done the CHEMIST study.

ESI1, second transcript

Reflections on the use of the theoretical framework of acceptability

We used the TFA47 to explore the acceptability of an intervention in this feasibility study. This provided a useful analytical framework and allowed a more in-depth, multidimensional, theoretically informed analysis of acceptability across the data sets than the initial thematic analysis of each data set allowed.

The TFA can be used to investigate acceptability in three ways: prospective acceptability (prior to participation in the intervention), concurrent acceptability (while participating in the intervention) and retrospective acceptability (after participating in the intervention). We collected data at one time point (after participants had participated in the intervention) and, therefore, undertook a retrospective assessment of acceptability.

Sekhon et al. 47 present the constructs of the TFA in alphabetical order and outline the extent to which they may cluster or influence each of the temporal assessments of acceptability as an empirical question. The process of mapping subthemes from the thematic analysis to TFA constructs was not always straightforward, as some subthemes were aligned with more than one TFA construct. When this happened the research team made decisions about which construct best represented the theme. Our analysis suggests that the constructs are interconnected. For example, intervention participants’ perceptions about how they felt towards the ESI (affective attitudes) were often linked with feelings about how recommendations from the ESI facilitator added extra work (burden).

Although all of the TFA constructs represented in these findings were important for assessing acceptability of the ESI, some were more populated than others. For instance, most of the data that contributed the most insight and support for intervention participant acceptability of the ESI were mapped across three TFA constructs (affective attitudes, intervention coherence and perceived effectiveness). Less data were mapped to the TFA constructs of self-efficacy and opportunity costs, and no data were mapped to the TFA construct of ethicality. This lack of findings linked to ethics issues may be explained by the fact that the topic guide was not developed using the TFA constructs.

Recruitment methods/strategies

The original protocol involved sending the baseline questionnaire to all those potential participants who returned a consent form and background information sheet to the study team. On receipt of a completed baseline questionnaire, potential participants would then be contacted by the study team to determine study eligibility (including the MINI diagnostic interview48), with eligible participants thereafter being included in the study. This procedure was amended prior to the start of participant recruitment to reduce participant burden and mitigate potential disappointment (for those potential participants who completed and returned a baseline questionnaire but who were then found to be ineligible to participate following eligibility screening). Instead, on receipt of a completed consent form, potential participants were first contacted by the study team to conduct the telephone-based eligibility screening. The baseline questionnaire was then sent to eligible participants to complete and return to the study team before their involvement in the study commenced. To capture information about all of the potential participants, the demographic questions originally contained within the baseline questionnaire were removed and included on the consent form and background information sheet.

A number of adaptations were made to the recruitment methods during the feasibility study, often with the dual aim of providing the wider pharmacy community with the opportunity to learn about the study and to improve the slower than anticipated rate of recruitment. CP staff provided consistent feedback to the CHEMIST study team that they felt unable to approach all eligible pharmacy customers about the study owing to limited time and resources, especially during busy periods (see Chapter 4), and that this lack of time affected recruitment. A number of additional recruitment strategies were, therefore, implemented. These are detailed in the following sections.

Qualitative study

Semistructured interviews with ESI facilitators aimed to explore their experiences of undertaking the ESI training and delivering the ESI in a single interview following ESI delivery. However, given the slow recruitment of participants, there was a delay in ESI facilitators gaining experience of delivering the ESI and, in order not to lose valuable information as to the utility of the study and ESI training, initial interviews focused on ESI facilitators’ experiences of the study and ESI training. These ESI facilitators indicated that they would be happy to participate in a second interview to discuss their experiences of delivering the ESI. The option of conducting a second interview was, therefore, included, along with the option of sending a reminder study invitation pack to those ESI facilitators who did not respond to the first invitation pack. In addition, to achieve data saturation, the target number of qualitative interviews to be conducted with ESI facilitators was increased from 4 to 10. These protocol changes were implemented after the study had been recruiting for 8 months.

Recruitment methods

In the feasibility study, eligible pharmacy customers who visited the pharmacy in person were approached by CP staff about the study and were provided with the BIS in the first instance; this advised them to request the full study information pack for further information. Some CP staff advocated for the potential benefit of providing the full study information pack directly to those eligible pharmacy customers visiting the pharmacy, reporting that pharmacy customers may often not get time to read the BIS while they are visiting the pharmacy and so they may not request further information about the study during that visit. They felt that this may improve recruitment to the study. Given the small number of full study information packs that were requested by pharmacy customers (potential participants), following receipt of the BIS during the feasibility study the protocol was amended to enable the full study information pack to be provided at initial contact (in line with other recruitment methods: home-delivered prescriptions, CP system searches and general practice database searches). The BIS was, therefore, not used in the pilot RCT.

Recruitment materials

Participant recruitment materials were revised for the pilot RCT. Feedback from the feasibility study (both via semistructured interviews with study participants and ESI facilitators and via general discussions with CP staff) suggested that some participants may experience difficulties reading the PIS because this was felt to be long and contained a lot of information. CP staff highlighted that because the study was recruiting in low socioeconomic areas, people may struggle to read and understand the PIS and, therefore, poor literacy may be a barrier to recruitment. The PIS was re-formatted to improve its appearance, with the information separated into clear sections. The complexity and length of some of the sentences were reduced and the language/words used were simplified to improve readability (this was reflected in a lower reading age score). The majority of the information provided in the feasibility PIS was maintained in the pilot RCT PIS, but an ‘Important things you need to know’ and a ‘contents’ section were added to the front page to facilitate understanding and readability. Revisions to the pilot PIS were made in consultation with the CHEMIST PPI AG.

An additional version of the PIS was developed to be used when recruiting participants through general practices. Participants recruited via this method may be asked to access a different CP to their usual one for their involvement in CHEMIST. CHEMIST researchers reported that some participants were not aware of this when they were contacted to discuss the feasibility study and that this may have contributed to some potential participants changing their mind about their interest in the study. The ‘GP PIS’ included information about which CP participants would be required to liaise with if they were to be included in the pilot RCT but otherwise was identical to the ‘pharmacy PIS’. The ‘GP PIS’ was discussed and developed in agreement with CP stakeholders and the CHEMIST special interest group.

In the feasibility study, a number of potential participants placed a tick/cross in the consent statement boxes on the consent form (parts 1 and 2), rather than placing their initials as required. This often resulted in a delay to them commencing their involvement in the study, as participants were required to update the consent form or complete a second form. To reduce participant burden and the potential delay in starting the study, regulatory approval was secured to accept a consent form as valid if participants (including those participating in semistructured interviews; see Chapter 6) placed a tick/cross in the consent statement boxes, provided that they had printed their name and signed and dated the consent form.

Questionnaires

Feedback from both CP staff and study participants in the feasibility study suggested that some participants found the baseline and follow-up questionnaires too long, that they sometimes struggled to understand how to complete these properly and that some of the questions asked were repeated. Some participants took their questionnaire into the pharmacy for help completing it, and some CP staff felt that the questionnaires may lead to some participants questioning their further participation in the study.

In response to this feedback, the PHQ-1566 was removed as an outcome measure to reduce the number of questionnaires that participants were required to complete. Some participants reported feeling uncomfortable answering some of the PHQ-15 questions [e.g. those questions about menstruation (women only) and sexual intercourse]; this was not a questionnaire that was originally proposed as an outcome measure in the original funding application.

The questionnaire instructions for study participants were revised to facilitate better understanding and explanation as to how to complete the questionnaire. These highlighted why the questions were important for the study and that, although some of the questions may appear repetitive, all of the questions provide valuable information. Some participants reported finding the bespoke resource use questionnaire difficult to complete: the structure of this questionnaire was revised to aid ease of completion in the pilot RCT. A further question was added to ask about the number of pharmacy visits to further inform the cost-effectiveness evaluation. The CHEMIST PPI AG provided feedback on the revised questionnaires and found that these were to easier to read, understand and complete.

To improve participant experience of questionnaire completion in the pilot RCT, participants were routinely given the option of completing the questionnaires over the telephone with a CHEMIST researcher. Participants could still request to complete the questionnaires through the post if that was their preferred method.

Qualitative study

Although a number of CP staff participated in a semistructured interview and/or focus group in the feasibility study, their subsequent (informal) feedback suggested that some staff were initially reticent about their involvement in this aspect of the study. Reference to an ‘interview’ in the recruitment materials was reported to concern some staff, as they equated this term with going for a job interview. Some CP staff discussed their invitation with the study team and, following an explanation of what the interview would involve, agreed to participate. The qualitative recruitment materials to be used in the pilot RCT were, therefore, revised to invite participants to provide their ‘feedback’ rather than to participate in an ‘interview’.

Given that the pilot RCT ESI training workshop would introduce the qualitative aspect of CHEMIST (including an overview of the findings from the feasibility qualitative study), ESI facilitators were provided with the study invitation pack following completion of this training workshop. It was anticipated that this may lead to increased consent rates to the qualitative study.

The target interview number for CP staff was increased from 10 to 20 to allow interviews to be conducted with CP staff from across a range of pharmacy roles (to include ESI facilitators).

Self-help patient workbook

The self-help workbook used in the feasibility study was positively received by study participants and ESI facilitators (see Chapter 4); therefore, relatively minor revisions were made to this for the pilot RCT. Feedback (via semistructured interviews, informally during ESI facilitator supervision and reflections from the CHEMIST study team and various stakeholders) led to minor revisions that fell broadly within five areas, as briefly described in the following sections.

Enhanced support intervention facilitator manual

Minor changes were made to the ESI facilitator manual in the light of feedback from ESI facilitators and to align the ESI facilitator manual with the revised self-help patient workbook.

The word ‘supervisor’ was considered anxiety-provoking for some ESI facilitators, so this word was replaced with ‘study team advisor’. Further clarification was added around the timeline and process for contacting newly recruited participants and an explanation of the process of randomisation was included to align this with the pilot RCT.

Other changes

Numerous additional minor changes were made to the pilot RCT study documentation, including revisions to participant and GP letters and the development of new participant letters to better inform and maintain contact with participants throughout the duration of the pilot RCT.

Enhanced support intervention training

The ESI training is described in detail in Chapter 2.

Adaptations were made to the ESI training in response to formal and informal feedback from those ESI facilitators who completed the ESI training as part of the feasibility study (see Tables 14 and 15 for examples of interview quotations that informed/supported these adaptations).

Information about the ESI training was sent in advance of the pilot RCT training dates to all those CP staff identified to undertake the training. This included a copy of the self-help patient workbook, a brief description of the purpose of the study and what would be covered in the training, including role-play (described as skills practice sessions). This would allow CP staff to attend the ESI training with prior knowledge and relevant expectations.

Key aspects of the ESI training delivered in the feasibility study were identified and the training was modified to address/acknowledge the following areas: (1) preparing the ESI facilitator for complex participants (e.g. those with multiple LTCs); (2) discussing the importance of risk assessment; (3) the need for ESI facilitators to feel confident and comfortable to use the study materials (e.g. self-help patient workbook and the ESI facilitator manual) flexibly in response to participants’ circumstances and LTCs; (4) discussion of familiarity and confidentiality with pharmacy customers and the associated strengths and limitations; and (5) importance of good listening skills.

The training was further adapted to better emphasise/highlight the links between physical and mental health with case/patient stories used to illustrate the complexity of these links. The self-help patient workbook was also modified to emphasise this important link (see Self-help patient workbook). The updated training sought to increase understanding and awareness that a person’s LTCs can limit their ability to engage with the BA component of the ESI (identified as a key component of the ESI), and work out how to effectively and appropriately modify the BA in response to a person’s LTCs.

An important training update was to describe the experiences gained from the feasibility study, including findings from the interviews/focus group with ESI facilitators and CP staff. This not only served to highlight how valuable and vital this feedback is to the study, but also served to provide real-life context to the study by providing concrete examples.

A key theme from the feasibility study was the importance of ensuring that ESI facilitators (and those CP staff involved in recruitment) felt supported to engage with the study. The clinical supervision provided to ESI facilitators was seen as a vital mechanism by which to provide ongoing support throughout the delivery of the ESI. ESI facilitators were made aware during training that they would receive regular clinical supervision and that they could contact their supervisor (or any member of the CHEMIST study team) at any time if they had any questions or concerns.

General study and recruitment training

A brief description of the general study and recruitment training delivered to CP staff is described in Chapter 2.

A number of adaptations were made to the study training and related study documentation and procedures in the light of feedback from CP staff and the experiences of those CHEMIST researchers who designed and delivered the feasibility study training.

Community pharmacy staff suggested that the study training session was too long (4 hours) and involved too much information/detail about the study (although it was noted from semistructured interviews that some CP staff felt that more information was needed to explain what was required of the CP). Study training in the pilot RCT was, therefore, split over two separate 2-hour sessions and the presentation/training slides were simplified to include the main/important information. Splitting the training into two sessions allowed CP staff to discuss the various study recruitment methods and procedures and how these might best fit into their existing routines; any issues or challenges could then be discussed within the CP and then discussed/confirmed during the second training session. The training also included the learning gained from the feasibility study in terms of what worked well and ways to mitigate or respond to problems, and highlighted how recruitment methods had been adapted in the light of feedback from CP staff.

Community pharmacy staff reported that they felt uncomfortable with approaching pharmacy customers directly about the study, especially given the mental health/low mood aspect. As was the case in the feasibility study, time was spent during training going through ways in which eligible pharmacy customers could be approached in person, with example ‘scripts’ provided (based in part on feedback/suggestions from CP staff involved in the feasibility study) that could be adapted to allow CP staff to feel more comfortable with how they approached customers. CP staff were advised that there was no requirement to mention ‘low mood’ or ‘mental health’ and that any questions that they might receive about the study from customers could be directed to the CHEMIST study team. Concerns could also be discussed during the regular telephone calls between the CP and the CHEMIST study team.

The paperwork that documented daily recruitment activity at each CP was streamlined with only minimal information required in an attempt to reduce the time taken for CP staff to complete this. The need for all CPs involved in CHEMIST to distribute a large number of study information packs to recruit (a relatively small number of) people into the study was discussed; this highlighted the importance of approaching and providing study information to as many eligible pharmacy customers as possible (not least to provide the opportunity for pharmacy customers to take part in the study).

Primary analysis

The intended primary outcome for the pilot RCT was the PHQ-963 at 4 months post randomisation. This will be summarised descriptively overall and by treatment arm. To explore any potential effect from the ESI, a linear regression model, adjusted for age, gender and baseline PHQ-9 score, will be undertaken. Given the small sample size, the results will be exploratory and should be interpreted with caution.

Secondary outcomes

All secondary outcomes will be reported descriptively, as detailed above. No formal statistical comparisons of these measures will be undertaken.

In addition, the pharmacy effect will be explored using the intracluster correlation coefficient and the associated 95% CI to determine whether or not the effect of the intervention differed across the recruiting CPs.

The average caseload per ESI facilitator will be detailed.

Quantitative outcomes associated with the process evaluation (see Qualitative study) will be reported descriptively.

Interim analysis and stopping rules

No interim analysis was planned for this study and there were no stopping rules in place.

Participants

The aim was to purposively sample up to 15 study participants who completed the ESI to explore acceptability and important elements of the ESI, and up to 15 study participants who started the ESI but then dropped out (had less than two sessions) to explore their reasons for disengagement. All study participant interviews were conducted after the proposed primary outcome measure had been collected (4 months post randomisation) and at a time and location convenient to the participant (e.g. at home, in the pharmacy or by telephone).

The aim was to interview up to 20 pharmacy staff (ESI facilitators, general pharmacy staff and pharmacists) to explore important aspects of the ESI, ESI training and clinical supervision, and barriers to/facilitators of study participation and implementation. Interviews were conducted in person in a private room at the pharmacy or over the telephone, according to participant preference, at a time convenient to them.

To ensure confidentiality and to encourage interviewees to speak freely, interviews with ESI facilitators were not conducted with those study researchers who had been involved in their training (either ESI training or general recruitment training). Interviews with general pharmacy staff were conducted by a study researcher who had not previously been in contact with them as part of the study (i.e. had not been involved in their training and was not their CP’s main contact for the study). Study researchers who had had previous contact with interviewees were able to access anonymised interview transcripts only.

Interviews were also planned with up to eight GPs to explore their views and knowledge of the study, the ESI, how this may impact on routine primary care and the barriers to/facilitators of implementation. Interviews took place at a time and location according to GP preference (e.g. in the general practice, over the telephone).

Interview topic guides varied between participant treatment arms, but incorporated core questions used in the feasibility study (see Report Supplementary Material 8). These were developed by the research team and modified iteratively as data generation and analysis proceeded.

Recruitment

Study participants were recruited as described in Chapter 2 (see Report Supplementary Material 7).

Enhanced support intervention facilitators were provided with a study information pack (containing an invite letter, PIS, consent form and prepaid envelope) following completion of the ESI training (see Report Supplementary Material 9 for examples). The remaining pharmacy staff from the recruiting CPs (including general pharmacy staff and pharmacists) were posted a study information pack by the study team (see Report Supplementary Material 9). Interested pharmacy staff were asked to complete and return the consent form to the study team. A reminder letter was sent to all pharmacy staff once ESI delivery had ceased at each pharmacy. This process was carried out independently of the pharmacy to ensure that it was free from pressure from managers or co-workers.

General practitioners of recruited participants and GPs from those practices involved in the identification of potential participants were posted the study information pack (see Report Supplementary Material 10). Interested GPs were asked to complete and return the consent form to the study team.

Analysis

Interviews were recorded, with participant consent, using an encrypted digital audio-recorder and transcribed verbatim independently of the study team. Transcripts were then anonymised by members of the research team to ensure the confidentiality of participants. A framework analysis was conducted using NPT. 45 NPT supports the identification of key factors that enable or constrain the successful normalisation of an intervention into routine working practices. 77 By applying the NPT domains, the pilot RCT process evaluation explored how participant groups made sense of (coherence) and engaged with (cognitive participation) the ESI. In addition, the work completed and needed to facilitate the intervention (collective action), as well as participant’s appraisal (reflexive monitoring) of the intervention, was explored.

Data were coded directly to the NPT domains (coherence, cognitive participation, collective action and reflexive monitoring) by three researchers (CS, LN and AP). These researchers were from a variety of professional backgrounds to increase the reliability of the analysis,70 and all researchers received supervision from a researcher experienced in the use of NPT (CCG).

Before formal data coding began, general reliability for coding data to the NPT domains was established. This involved researchers independently coding transcripts and then subsequently meeting to discuss and agree coding at a series of meetings supported by CCG. Although it is noted that different interpretations of the NPT domains can occur, this exercise was completed to begin to immerse researchers in the NPT framework and data engagement, as well as to establish a general agreement on coding. The coding process was supported by regular memo taking, with the purpose of recording emergent understanding of the data and to inform discussion and analysis between researchers.

Following the coding process, the analysis drew on principles of the constant comparison method. 69 This process involved comparing and contrasting coding both within and across participant groups under each NPT domain, with the purpose to explicate phenomena within NPT categories. This was an iterative process that also involved moving back and forth between the meaning of the NPT categories described by Murray et al. 77 and the emergent phenomena observed in the data. Deviant case analysis was sought throughout the process. Subsequently derived categories and phenomena with NPT domains were discussed and agreed by researchers (CS and CCG) and are presented in Chapter 9.

A future definitive RCT would involve a mixed methods process evaluation incorporating mediational and moderational analyses to investigate mechanisms of change. 78 Mediational analysis would examine outcomes such as number of ESI sessions, content of ESI sessions and changes in activation (using the BADS). Moderational analyses would examine baseline variables that may moderate outcomes such as age, depression onset age, number of episodes and socioeconomic status. Although the current pilot RCT would be underpowered to undertake these analyses, data will be reported descriptively, where feasible.

Primary outcome measure

The intended primary outcome measure for the pilot RCT was the PHQ-9,63 measuring depression severity at 4 months. The PHQ-9 is scored between 0 and 27, where higher scores represent a higher level of depression.

In addition to the descriptive overview of the PHQ-9 scores presented in Table 21, a linear regression model adjusting for allocation, age, gender and baseline PHQ-9 score was undertaken to explore any potential effect of the ESI. This found that, at the 4-month follow-up, the average PHQ-9 score was 0.77 points higher (indicating a higher level of depression) among participants who received the ESI than in the usual-care arm (95% CI –2.05 to 0.97 points). The CI suggests a potential benefit of the intervention of up to 2.05 points or a potential detriment of up to 0.97 points. These results are exploratory only and should be interpreted with caution, as the sample size for this estimate is small (n = 41).

To further explore this result, Figure 7a and b shows the breakdown of the change in PHQ-9 categories between baseline and the 4-month follow-up by treatment arm. This shows that the baseline PHQ-9 categories that saw the most change between the two time points were the moderate and moderately severe depression, and that those at the top and bottom of the PHQ-9 scale (those not depressed and those most depressed) had no change in PHQ-9 score regardless of which treatment arm of the trial they were in. This figure also indicates that all participants who were in the usual-care arm of the trial and had moderately severe depression showed a reduction in depression severity, despite not being offered the ESI as part of CHEMIST.

FIGURE 7.

Pilot RCT: (a) the change in the PHQ-9 category from baseline (left) to the 4-month follow-up (right) for the intervention arm; and (b) the change in the PHQ-9 category from baseline (left) to the 4-month follow-up (right) for the usual-care arm.

Results are shown only for those participants who provided PHQ-9 scores at both baseline and the 4-month follow-up.

Given the limited number of participants recruited per pharmacy (average 2.9 participants, range 0–10 participants), the pharmacy effect was not explored.

Secondary outcome measures

As in the feasibility study, the GAD-765 was also completed both at baseline and at the 4-month follow-up; the results are presented in Table 22. This measure was well completed, with the scores calculated for every returned questionnaire.

The BADS was sent to a total of 43 participants (the BADS was not sent to one participant in the intervention group as this was deemed by the study clinicians as inappropriate at that time). Thirty participants completed and returned the questionnaire (69.8%), with similar response rates across the intervention group (69.6%) and usual care group (70.0%).

Mediational and moderational analyses were not conducted (see Chapter 6, Qualitative study). However, data on age, LTC, depression severity and number of ESI sessions are reported in Table 19 (age and LTC), Table 21 (depression severity, PHQ-9) and Table 20 (number of ESI sessions). The number of episodes of depression (obtained via the MINI at baseline) was provided by 40 of the 44 randomised participants. On average, the participants had experienced 6.8 episodes (standard deviation 17.1), ranging from 0 to 100 episodes, although the data was skewed as the median number of episodes was 1.5. The mean was similar between the two groups: 6.9 episodes (standard deviation 20.7) for the intervention group and 6.6 episodes (standard deviation 11.2) for the usual care group. Twenty-nine participants who reported experiencing at least one episode of depression provided an age at which they experienced their first episode. This was slightly older in the intervention group (mean 34.4 years, standard deviation 23.6) than in the usual care group (28.9 years, standard deviation 16.0), and ranged from 9 to 85 years.

General pharmacy staff, enhanced support intervention facilitators and general practitioner participants

A total of 20 pharmacy staff from nine recruiting CPs participated in a semistructured interview. Nine of these participants were ESI facilitators, of whom five had experience of delivering the ESI. The remaining four ESIs received training in the ESI but did not deliver the ESI. All ESI facilitators were female and described their role in the pharmacy as dispensing; however, several ESI facilitators also mentioned additional pharmacy roles, such as delivering smoking cessation services, serving customers and labelling prescriptions. ESI facilitators’ years of pharmacy experience ranged from 5 to 24 (mean 12.3) years. Of the 11 general pharmacy staff (non-ESI facilitators) who were interviewed, nine were female, and their roles included counter staff, dispensers, pharmacists, senior pharmacy management roles and academic pharmacists. Years of experience for general pharmacy staff interviewed ranged from 3 to 22 (mean 12.22) years. In addition, three GPs, linked with two participating CPs (two females and one male), consented and participated in a semistructured interview.

Coherence

CHEMIST involved a novel intervention that was predicated on the relationship between physical and mental health. Several pharmacy staff described not considering these links prior to their involvement in the study:

I didn’t really like link them [physical and mental health] together, does that make sense?

ESI3

To be honest I wasn’t really aware of it until I went to the CHEMIST study training, until we went through it, but I can see why now.

PS10

For those pharmacy staff who undertook the ESI training, it appeared that the coherence of the relationship between physical and mental health became clearer following training:

I hadn’t really actually associated it with it, so it was quite, you know, it made us . . . it made us stop and think about it and think about the effects that long-term health conditions do have on people, you know. But I hadn’t . . . I hadn’t thought about it previously.

ESI3

For ESI facilitators, the experience of delivering the ESI seemed to consolidate their understanding of the links between physical and mental health:

I understand it more than I thought, you know, obviously the more you speak to people who do have long-term health problems more things come up like, you know, not being able to get out to see family, not being able to do something simple like going to do some gardening. So I understand, you know, the things that we maybe take for granted, you know, if that was taken away from us how that would affect, massively how would say not being able to even go to the shop, you know, simple things in life aren’t always so simple are they?

ESI2

The three GPs who were interviewed described CHEMIST clearly, indicating that the premise of the ESI made sense:

. . . so my understanding is that, um, that pharmacists, er, will be able to provide low-level interventions, er, to people, er, who were screened as having, um, symptoms of, er, lower-level anxiety and depression . . . um, which would hopefully have a positive impact on their consultation rate, and their psychological well-being, um, er, to, to, to really ultimately see whether there may be scope for preventing people, um, with more significant depressive symptoms hitting the GP longer term.

GP3

The ESI was generally seen by pharmacy staff as clearly distinct from other interventions that they had received training on or that had been carried out previously in pharmacies. Some pharmacy staff cited the process of keeping in contact with study participants as part of its distinction:

We’ve never really had to like make appointments and things and see people like that. It’s normally on just a walk-in basis that we generally see people and then they just go. It’s more like if we were going to test their blood pressure or whatever it would be something we would offer when they came into the pharmacy and then if they chose not to, then that’s up to them. Obviously with the CHEMIST study when you have got a participant, it’s obviously keeping in contact with them which is something that we would do in the pharmacy.

ESI7 NDI

The distinction between the CHEMIST ESI and current practice at the pharmacy was also cited by some pharmacy staff as making CHEMIST more challenging to engage with than previous training undertaken within the pharmacy:

It is quite a lot different. I mean everything we do in the pharmacy we need training for, like we needed in the study. It was just . . . I don’t know how to word it, it was a different type of . . . I think it was a lot harder to get to grips with than other training that we’ve had for the pharmacy. I don’t know whether it’s just because everything you do in the pharmacy is just part of your role whereas this CHEMIST study was something new altogether.

ESI8 NDI

Some pharmacy staff, however, drew similarities between their current operational roles and the CHEMIST ESI. For example, one pharmacy staff member discussed that trust is established between pharmacy staff and customers during routine interactions in pharmacies, such as the medication review. Thus, it was thought that trusting the pharmacy staff might facilitate disclosure of how pharmacy customers might be feeling, and this made for coherent links with the CHEMIST ESI in relation to delivery and engagement:

. . . and in the pharmacies in the past, I used to find that people coming to the pharmacy and that trust is there automatically and people came to disclose a lot of their feelings to the pharmacist and when we started doing Medicines Use Review, which I know this study was sort of based around, I encountered a lot of people talking to me about how they feel rather than their long-term condition and that’s where I think the link between the two is very evident within pharmacy as well.

PS03

The perspective that pharmacists were well placed to pick up on patients’ health concerns was shared by GPs:

So, they certainly have a, a very valuable role in, in identifying patients, um, at an early stage . . . and their knowledge of a patient and their circumstances and their social circumstances is often as good as ours really.

GP3

Enhanced support intervention completers agreed with the view that the pharmacy was a potentially suitable place for a wider role in health-care delivery:

I’m interested in anything like that. I can see that there is potentially more of a role for pharmacies particularly as doctors get so busy. I always use the pharmacist if I’ve got any questions about medications rather than the doctors at least for first call because they do know their stuff, you know. They know what goes with what. If you’ve got a problem with a reaction or anything like that, they tend to be the ones that will know.

P03

However, some study participants suggested that they might prefer more traditional routes to help-seeking for mental health problems. One ESI non-completer said that they were not expecting the pharmacy to be interested in mood and that if they felt ‘really low’ they would prefer to consult their GP:

. . . mm I don’t know, I haven’t thought about that. I mean I don’t think I’ll go and say to [pharmacy staff member]. ‘Well, I’m feeling really low’, because if I felt really low I think I would go and see the doctor. But I do ask [pharmacy staff member] things when I go in about various things and say ‘do you think I should see the doctor about this?’ But it’s usually a physical thing that I’m asking about.

PNC01

Varying levels of sense-making work were required to integrate the ESI into a coherent activity for the pharmacy. It was recognised that mental health is increasing in profile and it seemed to make sense that this could become part of the remit of the pharmacy:

I think it’s becoming, I wouldn’t say more common knowledge now, but I think because mental health is rising the profile continuously, I think it will become more accepted to be done in the pharmacy as well.

PS03

However, for some pharmacy staff who did not undertake the ESI training, the rationale for the ESI seemed to have less coherence:

. . . well it might be a bit excessive but regards to the role that we played as recruiters, even if it was half a day’s training where we came with the intervention, the people doing the intervention training, just for the introduction and to listen to the slides being spoken about the rationale of why it’s being done so that everyone had a clear understanding of why we were doing it, how we were doing it and then we could leave.

PS01

One pharmacy staff participant discussed how they encountered initial resistance to implementing the ESI in the pharmacy, with staff raising questions about the rationale for the pharmacy being involved in and carrying out the intervention. This resistance was countered by other pharmacy staff who felt that the study offered an extension to the pharmacy role, which was positive for the pharmacy profession:

. . . think if I’m being a little bit negative there was a little bit of discussion around why are we doing this and obviously my argument around that it’s good, it’s good for the profession, we’re extending the role but there was a little bit of resistance to change.

PS09

Other pharmacy staff also drew on this narrative of CHEMIST being an extension of their current skill set. This rationale seemed to be, in part, how pharmacy staff made sense of their pharmacy hosting the CHEMIST ESI:

. . . again, it’s just showing that we can be involved in more than just the basic day-to-day dispensing. We’re there for all health-care needs not just the obvious ones.

PS11

Cognitive participation

Cognitive participation was required to assist both pharmacy staff and study participants to engage with the ESI. 45

Collective action

The operational work required for the study fell into two areas: recruitment to the study and delivering the ESI.

This first section describes the collective action involved in the recruitment of study participants (i.e. the identification of pharmacy customers/patients who were eligible to be approached about the study), as detailed in Chapters 2, 5 and 6.

Reflexive monitoring

The following section considers the reflexive monitoring of the participants by participant group. Both sections are supplemented with information from across participant groups where their voice is a key part of the discussion.

Data completion

At baseline and 4-month follow-up, all of the participants responded to at least one question in the resource use questionnaire (i.e. there were no participants who completely failed to answer any resource use items). Three participants in the ESI arm did not complete 4-month follow-up and, therefore, had no data available (note that this is also reflected in the overall questionnaire completion rate in the study).

However, a small number of data items were missing. Table 24 shows each resource use item with the corresponding number of missing data at each time point. The data completion rate was high in both treatment arms and at both time points: only one participant had missing data on certain items in each treatment arm. As a result, the response rate was comparable in the two treatment arms. When missing response items were compared, this indicated that the question about consultations with a GP at home and on the telephone may be more likely to have missing data (although this is observed in the case of only two participants in the study). Overall, the results indicate that participants were able to respond to the resource use items.

Frequency of health service use

Table 25 shows the frequency of use of each type of health service in the last 4 months, measured at baseline and the 4-month follow-up. Given the small number of participants, the aim of this section was to summarise the results for each treatment arm, but not to draw statistical inference regarding differences between arms.

At baseline, GP consultations and pharmacy visits were the most common categories of resource use. The mean number of GP consultations at the clinic was 4.21 and 1.65 in the intervention and usual-care arms, respectively, whereas the mean number of pharmacy visits was 5.5 and 4.75, respectively. At baseline, only a small proportion of visits in both treatment arms were because of low mood. The numerical range of the number of visits per participant was plausible for all resource use categories for both treatment arms. For almost all categories of primary/community care, the number of visits reported at baseline (except NHS direct visits) was higher in the intervention arm than in the usual-care arm. However, given the small sample size, the difference between treatment arms can be driven by a small number of observations; for instance, in the present case, the difference in GP visits was primarily driven by four participants in the intervention arm who had 10–15 consultations in the last 4 months. The observed pattern of resource use indicates that the cost-effectiveness analysis should control for any differences in baseline level of resource use.

At the 4-month follow-up, participants in the ESI arm reported a reduction in the number of all primary/community care consultations except for pharmacy and occupational therapist visits, the number of which had increased slightly. The usual-care arm showed a mixed pattern, with a slight reduction in GP consultations, NHS direct visits, and walk-in visits and a small increase in all other categories of resource use.

Table 26 shows the frequency of use of mental health and hospital-based services in both treatment arms at the two time points. The use of mental health services was very low in both treatment arms at baseline, with further reduction at the 4-month follow-up. None of the study participants had consulted a clinical psychologist or psychiatrist, which is not surprising given that the study participants were recruited into CHEMIST with subthreshold depression.

Table 26 also shows the frequency of use of hospital-based services in the two treatment arms at both time points. Only a small proportion of participants used hospital services. In the intervention arm, the number of outpatient appointments at baseline was 2.63 appointments over a 4-month period, which reduced to 1.1 appointments at follow-up. In the usual-care arm, the number of outpatient appointments was 1.95 appointments at baseline, which increased slightly to 2.1 appointments at the 4-month follow-up. Resource use in other categories was low in both treatment arms and time points, and the range of values were within plausible range. It should be noted that given that hospital inpatient visits (particularly those with overnight stays) are costly, a small number of outliers in this category can be highly influential in determining the difference in overall costs between the treatment arms. In the current study, one participant in the intervention arm had inpatient stays lasting 23 nights over three admissions. This was clearly an outlier in the data set and, therefore, was not included in the final cost analysis.

Unit costs of health service use

Unit costs were obtained from national databases, when available, and otherwise from other published sources. Sources and assumptions for unit costs are presented in Table 27.

Intervention cost

The intervention consisted of up to six sessions that were delivered by a trained member of pharmacy support staff (ESI facilitator). Table 28 summarises the number and duration of ESI sessions as well as the cost of the ESI. The mean number of sessions was four, with most participants having at least three sessions, and the range was one to six sessions (one session, n = 2 participants; two sessions, n = 1 participant; three sessions, n = 3 participants; four sessions, n = 3 participants; six sessions, n = 9 participants). Each session lasted an average of 31 minutes, with the range being 5–90 minutes. The total session delivery time per participant (across all sessions) was 136 minutes (mean), with the range being 20–305 minutes. In addition, data were also collected on the time spent on administrative tasks related to the sessions. The average administrative time (across all sessions) was 49 minutes per participant, with the range being 5–170 minutes.

The total ESI time (i.e. session plus administration time) was 185 minutes (mean), with the range being 25–360 minutes. In addition, each session required clinical supervision, lasting an average of 15 minutes, equal to 60 minutes over four sessions per study participant. The total time of the ESI facilitator was multiplied by their hourly cost (assumed to be a member of pharmacy support staff, employed at £9.88 per hour, i.e. scale 4 for local government employees). 83 Clinical supervision was provided by a grade 6 researcher (employed at £20.90 per hour). 84 The mean total cost of the ESI was £51.40 per study participant, with the range being £9–91 per study participant.

In addition to the above, the cost of training ESI facilitators on the CHEMIST intervention was estimated using the following information: each ESI facilitator attended a 2-day training workshop conducted by a mental health researcher (academic grade 6; hourly rate of £20.90) and a nurse consultant (NHS band 8b; hourly rate of £80.30), and the average cost of venue hire, catering and travel claims per workshop was £500. The average number of ESI facilitators trained in each workshop was 11.7. Based on this information, the cost of training an ESI facilitator was £181.70. This cost is in addition to the intervention delivery cost presented in Table 26.

Total cost of health service resource use

Figure 8 presents the total health service resource use cost in the last 4 months, by treatment arm and time points. Four cost components are presented separately: primary/community care resource use cost, mental health service use, hospital-based service use and intervention cost. These are in line with the data presented above.

FIGURE 8.

Pilot RCT: health service resource use cost, by time point and treatment arm.

At baseline, primary/community care resource use cost was higher in the intervention arm than in the usual-care arm. This is mainly driven by the larger number of GP consultations in the intervention arm. At the 4-month follow-up, these costs reduced significantly for the intervention arm, but remained stable for the usual-care arm.

The cost of mental health services was very small at baseline and follow-up for both treatment arms. The cost of hospital care was significantly higher in the usual-care arm at baseline and remained higher at the 4-month follow-up, although the difference became smaller. These differences were primarily driven by outpatient appointments and inpatient admissions without an overnight stay.

The total cost per study participant at baseline was £1145 in the usual-care arm compared with £933 in the intervention arm (difference: £212). The total costs were lower for both treatment arms at the 4-month follow-up (i.e. £728 for the usual-care arm and £490.70 for the intervention arm, including the cost of the intervention). The difference in cost was slightly higher at the 4-month follow-up (i.e. £237.30). However, these figures should be interpreted with caution because of the small number of participants.

Data completion

Data completion was 100% for all domains of EQ-5D and SF-12v2 at baseline and the 4-month follow-up in both the intervention and the usual-care arms. This indicates that participants found it feasible to complete these questions. This finding was consistent with results of the feasibility study.

Frequency and pattern of EuroQol-5 Dimensions item responses

Figure 9 presents the distribution of completed responses for each domain or item of the EQ-5D questionnaire at baseline and the 4-month follow-up in the intervention arm. At baseline, most participants had some level of problem in at least one of the five domains; study participants reported lowest level of problems in the self-care domain (i.e. 71% participants reported no problems). For the anxiety/depression domain, 6 out of 24, 15 out of 24 and 3 out of 24 participants reported no problems, some problems and severe problems, respectively (i.e. 75% of participants reported experiencing symptoms of anxiety/depression). This is not surprising given that participants with subthreshold depression were recruited in the study. At the 4-month follow-up, there was little change in the mobility, self-care and usual activities domains, a slight increase in the number of study participants reporting severe pain/discomfort and a slight decrease in the number of participants experiencing moderate anxiety/depression. However, the numbers are too small to draw any conclusions about the trend.

FIGURE 9.

Pilot RCT: EQ-5D responses at baseline and at the 4-month follow-up for the intervention arm.

Figure 10 presents the distribution of completed responses for each domain or item of the EQ-5D questionnaire at baseline and at the 4-month follow-up in the usual-care arm. At baseline, most participants had some level of problem in at least one of the five domains; as with the intervention arm, study participants reported the lowest level of problems in the self-care domain (i.e. 80% participants reported no problems). For the anxiety/depression domain, 75% of participants reported experiencing symptoms of anxiety/depression (i.e. the same as the intervention arm at baseline). However, in general, compared with the intervention arm, fewer study participants in the usual-care arm reported problems at baseline: this was true for all EQ-5D domains. This is important to note for a full-scale RCT, which would need to take account of differences in baseline quality of life between treatment arms: adjusting for baseline utility is recommended in the literature to avoid biasing results of the cost-effectiveness analysis. 85 At the 4-month follow-up, there was little change in the mobility, self-care and usual activities domains (same as the intervention arm), a slight increase in the number of study participants reporting severe pain/discomfort and a decrease in the number of participants experiencing severe anxiety/depression. However, the numbers are too small to draw any conclusions about the trend.

FIGURE 10.

Pilot RCT: EQ-5D responses at baseline and at the 4-month follow-up for the usual-care arm.

Frequency and pattern of Short Form-12 item responses

Figure 11 presents the distribution of responses for each item and domain of the SF-12v2 questionnaire at baseline and at the 4-month follow-up in the intervention arm. All items have five levels, except the two physical health questions (SF-2 and SF-3) that have three levels (see Chapter 2 for scoring of levels). At baseline, most participants had some level of problem in at least one of the domains; participants reported the lowest level of problems in the social functioning domain (which asks about physical health or emotional problems interfering with social activities): in this domain, at least 20% of participants reported no problems at baseline and at the 4-month follow-up. The domains with the highest level of problems were ‘general health’, ‘physical health’, ‘role physical’ and ‘vitality’. On the mental health domain, most participants (around 90%) reported some level of problems at baseline, with most of them reporting problems ‘some of the time’. This is consistent with subthreshold depression in this population. At the 4-month follow-up, there was a trend towards slight improvement in general health (SF-1). In addition, physical health problems (SF-2 and SF-3) appeared to get marginally worse over time. At the same time, the proportion of participants reporting extreme problems decreased in one domain (i.e. SF-11: feeling downhearted/low). Overall, although there was a slight trend towards health improvement in some domains, the numbers are too small to draw any conclusions about the trend.

FIGURE 11.

Pilot RCT: SF-12v2 responses at baseline and at the 4-month follow-up for the intervention arm. 4M, 4-month follow-up; BL, baseline. a, For SF-1, SF-8, SF-9 and SF-10, lower level (i.e. 1) indicates better health. For all other questions, lower level indicates worse health.

Figure 12 presents the distribution of SF-12v2 responses for the usual-care arm. At baseline, the pattern was similar to that in the intervention arm, that is most participants had some level of problem in at least one of the domains. Study participants reported the lowest level of problems in the social functioning and bodily pain domains: for these domains, at least 15% of participants reported no problems at baseline and at the 4-month follow-up. The domains with the highest level of problems were ‘general health’, ‘physical health’ and ‘vitality’. On the mental health domain, almost all study participants reported some level of problems at baseline. At the 4-month follow-up, there was no clear trend in quality of life, with some domains showing some improvement and others showing slight worsening. The proportion of participants reporting extreme problems remained stable at the 4-month follow-up. Overall, the trend was stable with marginal changes in some domains; however, the numbers are too small to draw any conclusions about the trend.

FIGURE 12.

Pilot RCT: SF-12v2 responses at baseline and at the 4-month follow-up for the usual-care arm. a, For SF-1, SF-8, SF-9 and SF-10, lower level (i.e. 1) indicates better health. For all other questions, lower level indicates worse health.

Health-related quality of life (utility values)

Figure 13 presents health-related quality of life (or utility) at baseline and at the 4-month follow-up (based on EQ-5D 3L responses, using UK tariff). The figure shows that participants in both treatment arms had low quality of life at baseline, which reduced further during the follow-up period. This is not surprising given the eligibility criteria of the study (i.e. patients with LTCs and subthreshold depression). On average, baseline utility level was lower among participants in the intervention arm than among those in the usual-care arm (difference: 0.096). During the 4-month post-randomisation period, utility values fell slightly in both treatment arms, but the difference remained almost the same (i.e. 0.101). However, as with the cost data, these results should be interpreted with caution as they are based on a small sample size.

FIGURE 13.

Pilot RCT: utility values based on EQ-5D 3L responses at baseline and at the 4-month follow-up by treatment arm. Numbers are rounded to second decimal place.

Feasibility study

Eight CPs participated in the feasibility study and 17 pharmacy staff completed the ESI facilitator training. The recruitment target (20–30 participants) was achieved, with 24 participants recruited across seven of the eight CPs and one general practice over a 9-month period. Initial face-to-face pharmacy recruitment was slower than expected, with pharmacy staff reporting difficulties in finding the time to raise the study with pharmacy customers owing to the busy nature of the pharmacy setting. To achieve the recruitment target, a number of additional recruitment methods were implemented, the recruitment period was extended and additional pharmacies were recruited (see Chapter 5).

Despite these various recruitment methods, the number of study information packs distributed was relatively small (n = 1082), with recruitment activity varying across CPs. Response rates to the study information were lower than anticipated (7.3% via pharmacy methods; 3.5% via general practice database searches) and are lower than those typically seen in primary care studies (18%). 38 The highest response rates were for face-to-face recruitment in the pharmacy, although these rates are based on small numbers. Conversion rates (from return of consent form to recruited participant) were similar across pharmacy (34.4%) and general practice recruitment (28.6%), and are comparable to those reported in primary care studies (28%). 38

Data completion across all outcome measures was excellent (95–100% of returned questionnaires), indicating that participants found it feasible to complete these. The retention rate at the 4-month follow-up was good (83%) and exceeded the target of 80%; one participant withdrew from the study.

Nine of the 17 trained ESI facilitators delivered the ESI. Engagement with the ESI was good, with 17 out of the 24 recruited participants (71%) commencing the ESI sessions. This level of engagement is comparable to engagement with psychological intervention services in routine care, in which 68% of people commence treatment, although is slightly less than that reported in primary care depression research studies (84%). 38,86 For those participants who commenced the ESI, 86% of all possible sessions were completed, with all participants completing at least two sessions, and 10 participants completing all six sessions. This compares favourably with routine psychological intervention services, in which 56% of people who enter the service attend two or more clinical appointments. 86

Depressive symptoms (as measured by the PHQ-963) appeared to reduce slightly from baseline to follow-up (mean reduction of 3.5 points), which reflected findings of the nested qualitative study, which found that participants reported positive benefits from the ESI. However, as the sample size is small and randomisation was not employed, this finding must be viewed with caution. Health economic analysis indicated that GP visits were the most common type of health service resource accessed, with only a small proportion of these visits being for low mood.

Data generated from semistructured interviews suggested that study participants felt that the CP was an appropriate place to offer a mental health intervention; that the ESI made sense and was acceptable; and that the ESI supported self-management of mood and LTCs. Study participants reported that they had engaged with the self-help materials and valued the contact with the ESI facilitator. Analysis of data generated by semistructured interviews with ESI facilitators suggested that ESI facilitators found the ESI to be acceptable. Despite initial concerns about delivering the ESI, ESI facilitators reported increased confidence with ESI delivery. The ESI training was reported as acceptable and useful, and suggestions were made to modify this training for the pilot RCT. ESI facilitators and pharmacy staff reported concerns about increased work burden and the practical challenges of study delivery in the CP, which were especially problematic at busy times. Fidelity to the ESI was not assessed as originally planned owing to concerns over the additional burden and anxiety this may cause ESI facilitators.

Pilot randomised controlled trial

Fifteen CPs participated in the pilot RCT, including six CPs that also took part in the feasibility study. An additional 18 pharmacy staff completed the ESI facilitator training. Recruitment remained a challenge and, despite greater engagement with recruitment activities in CPs and via general practice database searches, the recruitment period had to be extended by 6 months.

Forty-four participants (out of the target of 100 participants) were recruited and randomised (24 to the ESI and 20 to usual care) from across 12 of the 15 CPs and from five general practices. As in the feasibility study, recruitment activity varied across pharmacies. The response rate to pharmacy-based recruitment (2.7%) was lower than in the feasibility study (7.3%), although in the case of general practice recruitment response rates were similar (2.9% in the pilot RCT, 3.5% in the feasibility study). In addition, the conversion rate (from return of consent form to randomised participant) was lower in the pilot RCT (20.8% for pharmacy recruitment, 23.9% for general practice recruitment) than in the feasibility study; however, these conversion rates are still comparable to those reported in other primary care studies with similar patient populations (28%). 38 By contrast to the feasibility study, the different pharmacy-based recruitment methods yielded similar response rates (although numbers were again small).

As with the feasibility study, data completion of all outcome measures was excellent at baseline and follow-up (100% completion of returned questionnaires), confirming the suitability of these measures for use in this study. Retention at the 4-month follow-up was again excellent (93%), providing further evidence that it is feasible to retain and follow up this patient population. Two participants withdrew from the study.

Eleven ESI facilitators delivered the ESI (including five ESI facilitators who delivered the ESI in the feasibility study). Engagement with the ESI remained positive, with similar levels of engagement to that observed in the feasibility study. Of the 24 participants randomised to receive the ESI, 18 commenced the sessions (75%); this rate is above that seen in standard Improving Access to Psychological Therapy services in the NHS (68%)86 and slightly lower than that observed in similar research studies (84%). 38 For those 18 participants who commenced the ESI, 73% of all possible sessions were completed, with 16 participants (90%) completing two or more sessions and nine completing all six sessions. This level of treatment engagement is above that found in routine secondary care and is comparable to that reported in similar research studies. 38

There was a slight decrease in depressive symptoms at the 4-month follow-up in both the ESI and the usual-care arms, with a slightly larger decrease observed in the usual-care arm (mean reduction of 2.1 points and 1.1 points on the PHQ-9, respectively); however, the sample size (n = 41 at follow-up) is too small to draw any conclusions and the findings should be interpreted with caution. It is of note that the size of the decrease in depressive symptoms was less than that observed in the feasibility study, although baseline PHQ-9 scores were lower across both treatment arms in the pilot RCT than in the feasibility study.

Data generated from semistructured interviews with study participants, pharmacy staff (including ESI facilitators) and GPs were analysed using NPT. 45 The findings demonstrated that study participants found that the intervention made sense and was acceptable, that the support provided was perceived to be useful and that the self-help workbook was accessible and understandable, supporting and extending the qualitative findings from the feasibility study. Most participants who engaged with the intervention reported positive changes in mood and behaviour and viewed the relationship with the ESI facilitator as central to the intervention. Familiarity with pharmacy staff was viewed by some participants as a positive reason to participate in the study, whereas others felt that this may prohibit involvement because of concerns around privacy and confidentiality.

Pharmacy staff and GPs generally provided positive feedback about the intervention. ESI facilitators felt that the ESI training had extended their skill set and those who delivered the ESI reported gaining positive feedback from observing beneficial changes in the participants. Although some pharmacy staff found the study processes feasible to embed within their current pharmacy practice, others reported that the cumulative effect of numerous recruitment methods, and issues with limited availability of facilities for private consultations, impeded the working practices of the pharmacy. Delivering a mental health intervention in the CP was viewed as novel by some pharmacy staff, requiring a change in perception (for pharmacy staff and customers) about the role of pharmacy.

Considerable attempts were made in the pilot RCT to record ESI sessions to assess fidelity to the ESI. This was a new process for the ESI facilitators and the levels of anxiety reported were underestimated. Although some ESI facilitators agreed to record ESI sessions, this was achieved for only one session.

Economic analysis demonstrated high completion rates of resource (health service) use and quality-of-life questionnaires, with low levels of missing items. Visits to the GP, nurse and pharmacy were the most common types of resource use accessed. A small number of participants reported inpatient admissions (not related to mental health) during the study; however, owing to high unit cost, these inpatient attendances may have a significant impact on incremental cost and should be carefully considered in any future economic analysis. An imbalance in baseline quality-of-life scores between the two treatment arms was observed. There was some indication that the ESI might reduce the use of primary care and community services and hence costs, although the sample size was insufficient to draw any statistical conclusions. The ESI cost per study participant was £51.40, including the cost of delivering ESI sessions, administrative work and clinical supervision (based on four ESI sessions).

The pilot RCT incorporated progression criteria for a definitive RCT (although this was not part of the funded CHEMIST study) (see Chapter 1). The pilot RCT did not meet the recruitment target of 100 participants; 67% of participants randomised to the ESI completed at least two sessions (lower than the target of 80%, although it is worth noting that 90% of those participants who did commence the ESI completed a minimum of two sessions) and fidelity to the ESI was difficult to assess. However, retention at the 4-month follow-up was 93% (exceeding the target of 80%) and data completeness was excellent (100%).