This chapter details the changes that were made to the study and study protocol during the feasibility study and in preparation for the pilot RCT.
Many of the adaptations detailed were made in response to (1) analysis of semistructured interviews conducted with study participants and ESI facilitators, and a focus group with pharmacy staff (see Chapter 4); (2) discussions with pharmacy staff from recruiting CPs as part of their regular telephone calls and/or visits with the CHEMIST study team; and (3) meetings with the CHEMIST special interest group (see Chapter 2). This chapter, therefore, serves as a record of protocol changes made and a summary of the learning from the feasibility study.
Examples of findings/quotations that informed/supported these adaptations can be found in Tables 14 and 15.
| Item | Data | Lessons for pilot trial |
|---|---|---|
| Links between physical and mental health | I mean obviously after doing the training I’ve, I’ve realised it is. But yeah, I think obviously you can, you can tell when you speak to some people that they are quite, quite down and it probably is affecting, affecting their health, whether they realise it or not. But looking back, I think I can definitely, yeah . . .ESI6 | Links may not be understood: need to emphasise in training Links between physical and mental health were discussed during training |
| Importance of the broader social context of patients | Hmm [sighs] I, I, I, I’ve got a feeling; obviously it, it does link in somewhere along the line. First experience of me first participant that I’ve done the study with, she hasn’t had much of an improvement going through the booklet and I think more it’s, it’s been sort of other things that have been a knock-on effect of her long-term health condition. So she’s lost her job, she’s had a knee replacement, all sorts going on; so obviously everything is a knock-on effect of that, but the way, I don’t think she sees the long-term health condition as the factor, even though that’s the cause of all the other knock-on effects that’s causing, well-being the end cause of things anywayESI8 | Use of cases/patient stories to illustrate complexity important in training Patient stories were used during training to illustrate different levels of complexity |
| Physical health problems can limit people’s ability to engage in BA | Basically he had a, a lot of health conditions and it wasn’t the fact that it was his mood that was stopping him from doing things, it was more his kind of physical health conditions; had severe arthritis so he couldn’t grip anything, severe stomach reflux problems so he couldn’t really eat very much or go out and eat, and spondylosis, which is kind of like a compressed nerve type of problem, so he couldn’t walk, he couldn’t sit down, he can’t, he couldn’t, can’t stand for very long. So a lot of the problems were he just couldn’t do anything; so it was trying to suggest alternative things to things he used to do, but he just physically can’t do very much, not because of his mood, because of his physical health condition. So it was very difficult in that sense . . .ESI6 (second interview) | Important to cover in training and how BA intervention might need to be modified The impact of physical health problems as a barrier to undertaking meaningful activity was discussed during the training, as well as how this might interact with mood |
| Awareness impacts on understanding for usual work | In the CHEMIST study, it’s made me realise that there’s more people with underlying low mood than you could ever, ever imagineESI1 (second interview) | Relevance to usual work can be helpful to engage ESI facilitators and pharmacies |
| Implications for training | Well really [would have liked more information before attending the course], yeah, cos it was all rushed because we were, [researchers] came in on the Monday and we went on the training the following Thursday/Friday, cos I was on holiday, I had to cancel me holidays. So we went on the training the following Thursday and Friday. We work in a busy pharmacy and there’s no way that we had the time to even really look at the information. So we didn’t really look at the information until we were actually sat in the courseESI2 Uh huh that was far too intense, it was horrible, it was absolutely awful [laughter], not [trainer’s] fault [laughter] . . . and there was far too much role-play, the pressure was awful. Like after we’d done the training I was absolutely gutted that I’d decided to take part in it, but obviously once I’d gotten out into doing the sessions it was a lot more comfortable and easierESI8 (second interview) No. I think that [role-play] should probably be mentioned, cos I think a lot of people are quite uncomfortable with it. So I think possibly in the introduction to the whole thing, people should be made aware that actually there’s going to be quite a lot of role-playingESI8 Yeah, good. I think a lot of people find role-play daunting, and I do as well, to be honest with you, it was kind of, not embarrassing but daunting at the time. But I think it is needed, because I’ve been on training in the past, for example, the health, health, healthy living champion, where they just kinda say, there’s something, read it, right, you’re a healthy living champion, but you haven’t actually put it into practice. So I think that part of it was good, you need to be able to, when you do come to do an interview you need to be able to do it, and if, if you hadn’t actually practised it, rather than just reading a bit of paper, I think it would show and it . . .ESI6 | Supporting pharmacy staff to engage with trial is vitalNecessary to explore expectations prior to training (particularly around role-play)Supervision and support required to boost/maintain confidence A letter was sent out to all trainee ESI facilitators outlining the structure of the day and what they could expect. Attempts were made to make observation during role-play less intrusive while still allowing for meaningful feedback to be given |
| Did training prepare for intervention delivery? | I would say I wasn’t very prepared [after the training], I wasn’t prepared, you can never be prepared enough, and I just think I don’t want to feel like I’ve let my participants down; I don’t think I have with the last two, but the one than fell by the wayside, I think she needed more than I could possibly ever have given her; even with 3 weeks of training I don’t think I would have been at the standard she wanted me to be, whatever standard that is, so . . .ESI1 (second interview) Very good, very good. I think the, I know nobody likes it, I think the role-play was good, because I’ve done training in the past for things in here where they’re saying read this, read this, read this, right, go; and then you go, what was I supposed to do again? Whereas when you’ve actually, you’ve had some, [names supervisors] sitting there listening, doing the role-play and they kinda suggest things, you’ve already kind of had like a, almost a test patient so you’ve already ran through it, instead of reading a, reading a book and doing like a multiple choice questionnaire at the end, you know, when, when it comes to speaking to somebody face to face you, you’re trying to think back to that bit of paper you read, whereas when you’ve done it face to face you’ve already picked up a few kind of . . .ESI6 (second interview) | Supervision and support required to boost confidence ESI facilitators were given the opportunity to go over any areas they felt they required further support with immediately after training. They were offered supervision on a regular basis, usually weekly or after each participant contact. Frequency and content of supervision could be tailored to their individual needs. They had direct contact numbers for their supervisor and were encouraged to contact them between scheduled supervision sessions, if necessary |
| Pharmacy as a delivery site | 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 honestlyESI1 I think it would be a good thing to do in pharmacies, rather than people going to the doctors all the time, when they don’t really need to at first, they could come into the pharmacyESI3 It’s good for people who’ve lost sort of, we have, it’s awful to say, a lot of elderly patients and they lose loved ones, so obviously when they’re coming in and they’re getting quite upset, they fetch the prescriptions back, they fetch medication back, and they get quite weepy, which is understandableESI1 | Pharmacy acceptable: emphasise experiences in feasibility study in training for pilotParticularly for older adults: emphasise this in training During the training we made reference to experiences of delivering the intervention within the pharmacy, which had been encountered in the feasibility phase. We also had an ESI facilitator attend training who had supported a number of participants in the study to discuss their experiences Bereavement and the likelihood of this occurring in this population are discussed during training/included in cases for discussion. Support is provided during supervision to enable ESI facilitators to feel that they can discuss difficult issues and ones that may have a personal impact for them |
| Knowing customers | No, ‘cos they know, everybody knows everybody; that could put people offFG PS2 | Need to discuss familiarity and confidentiality with customers in training: strengths and limitations Confidentiality was discussed during training as well as possible implications for knowing the participant. Any particular issues which arose owing to familiarity could also be dealt with in supervision |
| Dealing with complex study participants | . . . the one thing that was a bit daunting was like my first patient was quite a complex case and I didn’t think we were going to get anybody who was depressed. I know it’s meant to be subthreshold depression, but she’s actually, I would say, quite severely depressed; I’m not an expert. But every single time she’s answered the DAS it’s been quite a high, well it’s been a very high score, she’s in the top end. That’s one thing that I didn’t think I was going to have to deal with; and sometimes when she’s told us stuff I’ve been like, oh I’m not, don’t feel qualified enough to give you any information. But then as I’d spoke to [names supervisor], who said, you know, like ‘You’re not there, just direct her to her GP, all you’re there for is to sort of work her through the booklet’ . . .ESI8 | Preparing ESIs for complexityRole of supervision Different levels of complexity were used in cases during training. ESIs were encouraged to discuss any issues that they felt were challenging during supervision, and frequency and content of supervision could be tailored to their individual needs. They had direct contact numbers for their supervisor and were encouraged to contact them between scheduled supervision sessions, if necessary |
| The value of the intervention | I think they felt quite comfortable speaking to us, well I would like to think that they did, and they, they did give feedback saying that they’d sort of felt like it had benefited them and it was nice to offload onto somebody who wasn’t sort of too involved in their personal life, somebody who sort of they could offload to and then go away and then forgotten aboutESI8 (second interview) | Being a good listener: important Person-centred listening skills were demonstrated and practised during training |
| Yeah, the structure, yeah, yeah, because obviously there was, you know, like there was plenty for [the participant] to do and concentrate on, the diary was very good, and she did fill that in, she was good at the diary, so yesESI19 | BA key component of the intervention Considerable emphasis is placed on familiarising the ESI facilitator with BA and how this can be explained and related to the participant | |
| Asking about risk | Asking the risk question, except it was a little bit daunting, you know, it seems like a very, it’s sort of almost looking a bit too far into people’s minds, but then at the same time I, I explained it was just basically for their safety; and people were pretty OK with that. And then obviously as the sessions went on it just became like a standard question, yeah, so wasn’t too bad, to be honestESI8 (second interview) OK, to be honest, 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 ask’d 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 thatESI1 (second interview) | Focus on risk assessment importantSupervision key A significant portion of training is taken up with discussing risk. Risk assessment was demonstrated during training and a structured SOP detailing the procedure to follow was given. Risk scenarios were role-played. Trainers were sensitive to the fact that risk might appear more daunting to the ESI facilitators, most of whom had little experience of mental health issues |
| Materials | Oh it’s fine, it’s self-explanatory; and then if you just go through the booklet, I mean it, it more or less tells yer, you just have to follow the booklet and follow yer client, you know. But yeah, I think, I think the booklet is, is good, for me, whether it is for the client; I mean people have different opinions. They didn’t like to, they didn’t like to fill in any of this, they didn’t want to put on this, their activities or . . .ESI2 (second interview) | ESI facilitators need to feel confident to use materials flexibly The training and manual emphasised that the self-help booklet should be used flexibly, working at the pace and taking account of the needs of the participant |
| Recruitment procedures | So me and [PS4] are from the same pharmacy and it’s quite a low income, low socioeconomic area. So we have a lot of patients that can’t necessarily read, write; and we’ve found, with relation to this, that was a big part of the problem with recruitmentFG PS3 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, yeahESI4 So initially it’s difficult to, to talk to every person that you want to talk to; it tends to be, you’re giving a prescription out, there’s a queue, so you’re just literally giving another prescription out or serving a customer. After a few weeks, we made an effort to, obviously, start talking to more customers, so asking people [staff] to drop down on the counter so I could discuss aspects with peopleESI1 I would say you can’t, me personally, cos I’m on the counter, the, the thing that I feel, if you’ve got the time to actually hand out a leaflet or be drawn into a conversation about low mood, to me that’s a lot better than just sticking a leaflet in a bag and walking away, taking the medication out and the leaflet goes in the bin. If you can have that contact with a client it makes it a lot better, and you can explain a lot more than a leaflet can. So I feel, personally, that that is more beneficial, and people, if they were interested, were openly talking about it, but due to ti, time restraints I couldn’t always do thatESI1 (second interview) So initially it was difficult; it got easier when we were allowed to put the leaflet information into bags, because when I was handing the prescription over it would have CHEMIST written on it, and it was an ideal talking point. So it was a lot easier when it became available that we could pop them in the bagsESI1 I mean a, quite a few of the customers seen the posters, so that was good, they like, you know, they approached us, so that was nice. And, like I say, I do know quite a few people in the, the chemist, so like looking at prescriptions and things like that sometimes could give you a little bit of an idea that I, you know, and then I could approach them and, like I say, they’re all lovely, so, you know, they either say, oh yes or no, you know, so they’re, they’re good reallyESI9 | Poor literacy a barrier to recruitmentDirect approach to customers felt to be uncomfortableLanguage used is important (need to be flexible/develop a ‘script’ to feel comfortable using)Having a variety of recruitment methods was helpful |
| Impact on the pharmacy | I mean initially it [pause] staff-wise, I think if we’d had more staff we could have gotten, we could have recruited more people, it was finding the time to get out, ‘cos [. . .] you haven’t got time to look up when you’re on the counter; and I think there’s probably a lot of people that we haven’t asked, but it’s just getting that time. And we ha, now when they come in and now the questions are different and you’ve just got to ask them that brief sentence, and if I spot people I’ll go out and ask them, but it’s, it’s, it’s finding the time to, to get to themESI2 (second interview) I would say yes, as long as the funding’s there to cover it, because obviously pharmacies are like really restricted on what we can do at the moment, there’s cuts left, right and centre, so fitting extra things in with no extra funding would be very difficult. It was hard fitting in the time, to be honest; I think that’s one of the things that was tough, because we’re so busy, we’re, there’s only so many members of staff, we don’t have extra staff in when we’re sort of doing the CHEMIST study, we’re trying to fit it in around everything else that we do, because we are a busy little pharmacy and we never stop. So that’s probably one of the things that could be put maybes as a, as a negative, sort of trying to fit it in around putting it in with yer usual sort of jobESI8 (second interview) No [laughs] apart from losing us for half an hour/40 minutes a week. We’ve struggled in the pharmacy because it, it’s a really busy pharmacy and you do a session and it’s probably half an hour/40 minutes and then we would talk it over with [names supervisor] the next day, so then we’d taken away then. So I think for the pharmacy it was maybes a bit frustrating. I think like [the pharmacist] said, it works, it does work, but whether it works in a busy pharmacyESI2 (second interview) | Lack of time impacted on recruitmentMore information when introducing study and at site visits needed to explain what was required of the CPOpportunity costs: how to incorporate the CHEMIST work into a routine working day should be a key part of training: anticipating barriers and suggesting solutions |
| Item | Data | Changes made |
|---|---|---|
| Self-help booklet | . . . it could have been set out in the stages, that would have made life a lot easier, however sort of the, sort of the idea of setting the diary out and; things are laid out pretty well, I just think it needs re-grouping into sort of sessions rather than stages, because, like I said, in, in the beginning where you do the introduction and then part of stage one or however it’s, part of, part one of the booklet makes it a bit too confusing, especially for sort of older people and people who sort of struggle with absorbing things, maybes that’s the way to put it. It would be, be a lot easier if it was laid out session 1, session 2, session 3ESI8 (second interview) . . . so you’ve got the introduction and then the, the cycle. So that’s stage, well session 1, but they, they stage different, differently throughout the booklet, so you’ve only got six sessions but eight stages. [Q laughs] So that’s, that’s the, that’s the harder thing to try and sort of, you know, manoeuvre into each session, which one you’re going to do correctly, instead of it just being, you know, like, you know, today this is session 1 in the booklet, this is what we’re going to do; that would be a lot easier than going, you know, we’re, we’re going to do session 1 and 2 today, session 1 was stage . . .ESI8 Like I would have thought like a session 1 would have been put into a session 1 and then a session 2 into a session 2 where it was just on its own; I just thought it was a little bit like all overESI9 . . . once people kinda make their mind up and think I’m not depressed and I don’t need to do it, you’ve lost them, I thinkESI5 . . . a lot of people are in denial about it, aren’t they? Yeah, it’s kind of a big, scary word to some people, isn’t it? Especially in an area like this, you know, men, they live in the dark ages [laughs] so it’s like something that would never be spoken about. So if they read that word, even the subclinical depression, that’s just gonna tip them over the edge. So yeah, I think people would presume that it was about people who were depressed and if they think they’re not then they’re not gonna bother, they’re not gonna bother filling out the, the rest of itESI5 | A number of stages in the self-help workbook were combined so that the stages aligned with the number of intervention sessions (n = 6)The term ‘depression’ was removed from the CHEMIST materials and replaced with ‘low mood’ |
| Recruitment methods | . . . we do about 276 deliveries, and you’re missing all those people. So I think that [home deliveries] should have been looked into before we got this far down the lineESI2 Yeah, I, I mean obviously I, it was mostly me had a lot of time to do with, with the recruitment process; I did a lot of the postal packs which we found use, useful, the kind of walk-in side, the face-to-face approach was very challengingESI6 (second interview) . . . about, and I didn’t think there was enough information on that one sheet for them to then make a decision, and I did find that I’d say that this is, this is about can I give you a pack; so they would take a pack. So we found a lot more people recruited that way, rather than just off this one sheet; and I think we found giving the packs out on delivery tend to have a bigger response because they had, I think, more informationFG PS5 Do you feel, yeah, low; I think a lot of people thought oh my God, I don’t get depressed, I haven’t got mental health issues, and I don’t think they liked it. I didn’t, and they didn’t like to be asked at the counter, they didn’t like to be asked at the counter, whereas if you just were saying now, oh the university are doing a trial on people with long-term conditions and how it affects their mood, would you be interested; they’re fine with that. But actually when we were doing it the other way, where you were asking the questions at the counter, they, they, it wasn’t, no, wasn’t goodESI2 (second interview) . . . but we know everybody; and what worked better, when it came to the end of the trial when [name] was saying ‘Instead of asking them these questions, why don’t you just say, when you’re handing the prescriptions out, you’ve got a long-term condition, would you be interested in helping out on a trial about how it affects yer mood?’ And that was much better, that was much better than asking the questions . . . [talking together]FG PS1 | Home deliveries were included as a recruitment method in the pilot RCTCP system searches for potentially eligible participants were undertaken in the majority of CPs involved in the pilot RCTThe BIS was removed in the pilot RCT: each person approached was given the full study packThe general study training for the pilot RCT emphasised that when CP staff were approaching customers about the study, they did not have to mention the ‘low mood/mental health’, just that the pharmacy was involved in a research project looking at long-term health conditions |
| Paperwork | Paperwork; the amount of paperwork that’s involved is colossal, we’ve got paperwork on top of paperworkESI1 There is a lot of paperwork; when we were doing, obviously the bag, popping them in the bag, there was a lot of paperwork involved there because obviously they had to take the names down. So the way we, obviously, did it, we had an A4 sheet of paper, just wrote the initials down, and the illness that they qualified for, and then we were waiting until we got sorta 10 and 20 on the sheet and then I would fax it acrossESI1 (second interview) I think maybe the, the self-help book, possibly if we’d had that before, just to have a read through and just get a general idea what it was going to be about. That might have, might have been something, yeahESI6 | The amount of information collected on the study activity log was reduced significantly to collect only the number of people approached by each method of recruitmentIn the pilot RCT, the self-help workbook was sent out in advance of the ESI facilitator training |
| Case report forms | . . . exactly what [PS 3] says, even if people can read and write, the forms are difficult. I’ve had two people that have had to come in and I’ve had to sit down with them and fill it in with them; they found the forms really difficult. And you don’t get to see these forms when you’re training; so it was new to me when they brought this form in, with loads of pages with questions that they obviously thought were, were getting duplicated all the time; well you’ve just asked us that question, that’s just the same as that, isn’t it? And I said well not exactly. But they found it quite difficult; and I think a lot of people might get the telephone call, call, agree to do the trial, get the forms, and I think will take a look of it and think I’m not filling that in, I really doFG PS1 Yeah, well I’m, I’m going through like with two customers and it’s on about sexual intercourse; why do we, why do we need to . . .FG PS1 | The instructions for study participants within the questionnaires were revised to facilitate better understanding and explanation as to how to complete the questionnaireThis outcome measure was removed from the case report form |
Adaptations and protocol changes made during the feasibility study
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.
Providing study information with pre-ordered prescriptions
Community pharmacy staff reported that they were often unable to approach those pharmacy customers who visited the CP to collect pre-ordered prescriptions because these customers are not required to wait in the pharmacy for their medication to be dispensed. CP staff suggested including the BIS in pre-ordered prescription bags. Customers could then read the study information in their own time and request the full study information pack the next time that they visited the pharmacy. This additional recruitment method was added after the study had been recruiting for 2 months.
Providing study information with home-delivered prescriptions
During regular discussions with recruiting CPs, CP staff highlighted that those pharmacy customers who received their prescriptions/medication via the pharmacy home delivery service, rather than visiting the pharmacy in person, were not likely to receive information about the study. An additional recruitment method was, therefore, introduced that allowed CP staff to provide those eligible pharmacy customers who received home-delivered prescriptions with information about the study. This protocol change initially allowed CP staff to include the BIS in home-delivered prescriptions; however, this was amended so that the full study information pack was provided, thereby reducing the burden of participants initiating contact with their CP and/or the CHEMIST study team to request a full study information pack. This additional recruitment method was introduced in month 5 of recruitment.
Community pharmacy system search
An additional recruitment method was implemented after the study had been recruiting for 3 months that allowed CPs to conduct searches on their pharmacy database/systems to identify customers eligible to receive study information in the post. This recruitment method was added to aid CPs with the identification of eligible pharmacy customers and to increase recruitment to the study by reducing (although not removing) the need for CP staff to approach all eligible customers who visit the pharmacy in person.
Other changes
The time frame in which members of the CHEMIST study team could contact potential participants following receipt of ‘verbal consent to contact’ was reduced from a minimum of 1 week to a minimum of 2 days in month 5 of recruitment. Feedback from the CHEMIST study team who were contacting potential participants in this way suggested that the original 1-week time frame was perhaps too long because some pharmacy customers struggled to remember the study information that they had received 1 week earlier. This revised time frame is often used in primary care mental health studies and was considered to represent an adequate length of time in which the participant had time to read, digest and discuss the study with their family/friends/GP.
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.
Adaptations made in preparation for the pilot randomised controlled trial
An important aim of the feasibility study was to develop and refine the study procedures and materials for use in the pilot RCT. The learning acquired from the feasibility study facilitated the refinement of the study procedures and documentation in preparation for the pilot RCT. Many of the protocol changes that were made during the feasibility study were maintained in the design of the pilot RCT. Additional protocol changes made prior to the commencement of the pilot RCT and other changes are detailed in the following sections. These changes were discussed in collaboration with CP staff and study stakeholders (including the CHEMIST PPI AG and the CHEMIST special interest group; see Chapter 2) and were informed by the results of the feasibility qualitative study.
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.
Revised stages
The self-help workbook contained eight stages delivered across up to six ESI sessions. Although the workbook was designed to be used flexibly and in response to individual participant circumstances and experiences, some CP staff reported that they might find it easier to work with the workbook if the stages aligned with the sessions. As a result, some of the stages were combined to create a six-stage workbook for use in the pilot RCT (see Chapter 6).
Removal of reference to depression
Feedback suggested that the workbook should not reference ‘depression’ because some participants may not understand or equate their current symptoms with this term (given the study concerned people with subthreshold depression/low mood). Reference to the term depression was, therefore, removed from the workbook for the pilot RCT. Examples included revising ‘Understanding what depression is, so it may be recognised in future’ to ‘Understanding what low mood is, so that it doesn’t get worse in the future’, and ‘Some people lose their appetite and start to lose weight when they are depressed’ to ‘Some people lose their appetite and start to lose weight when they feel low in mood’.
Links to physical health problems
The workbook was revised to include additional references to physical health problems to further emphasise how mental and physical health are linked. For example, when describing the cycle of low mood (‘In order to break the cycle it is important to plan activities that reconnect or maintain your connections with things in your world that are healthy for you. We call this planning to maintain a healthy mood’) the following sentence was added: ‘This is particularly important for people who have physical health problems to help them stay well’. When discussing breaking down tasks into smaller more manageable steps, the wording was amended from ‘They do not need to be done all in one day’ to ‘Remember, it does not need to be done all in one day, often when you have health problems doing too much in one go is very exhausting. This can lead to feeling overwhelmed and then not doing other things that you like doing’.
Positive wording
Some of the wording was amended to emphasise positive action. Examples included amending stage titles such as ‘An 8-stage plan to help you keep well and prevent depression’ to ‘A 6-stage plan to help you keep a healthy mood when you have long-term health problems’, and amending ‘Spotting the symptoms of depression’ to ‘Spotting the symptoms of low mood and making an action plan to stay well’.
Further clarifications/explanations/descriptions
Other minor revisions were made to aid clarification or to provide further explanation or descriptions of concepts or situations described.
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.
Training
An important aim of the feasibility study was to evaluate the training delivered during the study. This included the ESI training for ESI facilitators and general study and recruitment training for CP staff within recruiting CPs. Feedback was obtained via semistructured interviews and focus groups, and informally via discussions between CP staff and CHEMIST study team members.
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).
Chapter summary
The feasibility study provided an important opportunity to develop and refine the ESI (materials and training) and study procedures (identification, screening, recruitment and assessment of participants, suitability of outcome measures and data collection processes) for use within a CP setting. Semistructured interviews with participants and ESI facilitators, and a focus group with CP staff, provided rich and detailed data on the acceptability and experiences of the study. These data were further informed by ongoing discussions with recruiting CPs, CP staff and CHEMIST stakeholders (including CP and public health specialists and the CHEMIST PPI AG) throughout the duration of the feasibility study and via the study team’s experience of conducting the study. These data identified a number of challenges to the delivery of the feasibility study (most notably with respect to participant recruitment) but also provided an opportunity to work closely and collaboratively with recruiting CPs and CP staff to identify and explore alternative/additional strategies/or solutions. This combination of qualitative data collection and collaborative discussions provided a critical learning opportunity that fully informed the design and delivery of the pilot RCT.
The CP is a new area for mental health research and represents a relatively novel setting in which to conduct depression prevention studies, such as CHEMIST. Many of the CPs involved in the CHEMIST feasibility study had limited experience of research and, for this reason, had few established processes for research delivery. The feasibility study provided important reflections on how to embed research and study processes in this busy public health setting. The learning acquired from conducting the feasibility study was critical in refining study procedures, training and materials for use in the pilot RCT and will also be useful in the design and delivery of future studies within pharmacy. Clinical research networks are keen to expand the delivery of research within this important public health setting and the establishment of primary care networks will further facilitate important collaborative and interdisciplinary working across key stakeholders.