Pilot randomised controlled trial: qualitative findings

The procedures that were used to recruit participants to the pilot RCT qualitative study are described in Chapter 6.

Study participants

Given that recruitment to the pilot RCT was slower than expected, all those participants randomised to the ESI arm who provided their consent to participate in the qualitative study (n = 18) were approached to take part in a semistructured interview.

Thirteen of the participants who had completed the ESI (termed ESI completers), and who were recruited from nine participating CPs, took part in a semistructured interview; two ESI completers declined to be interviewed. The age of the interviewed ESI completers was between 48 and 87 years (mean 71.7 years). Five participants were female, and the number of ESI sessions completed by those interviewed ranged from two to six (mean 5.4 sessions). The LTCs reported for this treatment arm included heart problems, diabetes mellitus, arthritis, chronic obstructive pulmonary disease (COPD), emphysema, psoriasis, coeliac disease, cancer, hypertension and lung disease.

In addition, a total of three study participants from three participating CPs who either decided not to start the ESI sessions or started the ESI sessions but did not complete these consented and took part in a semistructured interview (these participants will be referred to as ESI non-completers). ESI non-completers were aged between 65 and 67 years (mean 66.3 years) and two ESI non-completers were female. One ESI non-completer completed two ESI sessions but then decided not to continue, reporting no benefit from the sessions. The other two ESI non-completers who were interviewed reported an operative procedure (in one case) and a miscommunication in the pharmacy (in the other case) as reasoning for not starting the ESI sessions. LTCs reported by the ESI non-completers were COPD, arthritis, heart problems, joint problems and asthma.

All interviewed study participants described themselves as being of white ethnicity.

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.

Data analysis

As described in Chapter 6, data analysis focused on a theory-driven approach that was guided by the four main constructs of NPT:81 coherence, cognitive participation, collective action and reflexive monitoring (Table 23 shows a description of the NPT domains). Although the initial intention was to carry out both a thematic analysis and a NPT analysis of interview data, coding researchers discussed that the NPT framework appeared to capture most phenomena observed in the interview transcripts. In addition, the process of constant comparison69 in the framework domains allowed for the production of inductively derived categories. The process of data exploration appeared to negate the need to carry out an additional thematic analysis, and it was decided that data analysis would take the form of a primary NPT analysis.81

Taking this rigorous approach, it was not thought that important data were overlooked, and the NPT framework was applied as a sensitising theory for data analysis.82 In addition, as discussed previously, given that initial coding was carried out independently and researchers met regularly to discuss emerging themes, the possibility of overlooking any key themes not captured by the NPT-sensitised analysis was reduced. Disconfirmatory evidence was sought in the data throughout the analysis.

The qualitative analysis of interview data by the four NPT domains are presented in the following sections. Illustrative data are provided to support analysis and are labelled by identifier and number (e.g. P = ESI completer, PNC = ESI non-completer, ESI = ESI facilitator, ESI NDI = ESI facilitator who did not deliver the ESI and PS = pharmacy staff).

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?

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.

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.

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?

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Cognitive participation

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

Cognitive participation for pharmacy staff

Pharmacies came to participate in CHEMIST via a number of routes. In some cases, senior pharmacy staff volunteered their pharmacy to participate in CHEMIST by responding to an ‘expression of interest’ e-mail that was sent to pharmacies:

It was me colleague that signed the branch up for it but I think there was an e-mail that was put round and we just signed up that way because we’re keen to involve, we do lots of services, and we’re keen to involve other new services at this branch.

Other pharmacy staff were approached directly by their manager and asked to deliver the ESI:

Yeah it was just my manager put me forward for it. I was never really got given any information, it was just, ah this is what you’re doing and I read into it and I thought actually it might not be too bad.

My boss just approached me but I think [they] knew I was a bit of a mental health geek and it would be something I would enjoy; I think more than anything and something that I would probably put 100% to because it’s of interest to me.

Other pharmacy staff reported that they had volunteered for the role of ESI facilitator:

The pharmacist like spoke about it to all of us and asked if anybody would like to do it, so me and one of the other girls said that we would.

More senior pharmacy staff often suggested that a reason for participating in CHEMIST was wanting to be (more) research active:

. . . it was in regards to being research ready, I had never taken part in research as a [job role] or let alone be a [role in the study]. So from a continuing professional development point of view that was very useful for me.

In addition, some pharmacy staff and ESI facilitators described already having an interest in mental health, and others described altruistic motives that the intervention might help others:

I just think it’s interesting, mental health and I just wanted to know more and see if I could help people. I was interested to see if, when they were saying that something that pharmacy, community pharmacy could help with, I was interested to see how or why.

Other respondents suggested that CHEMIST might be something that the pharmacy customers were interested in:

Yeah it was a bit strange at first but then I thought, no, you know, something that some people might be interested, it might do them good to talk and things like that, so you know, that didn’t bother me in the end because like you say I know my customers well enough to, you know, speak to them more freely.

Expanding the role of the pharmacy to deliver a talking therapy was also something that was highlighted by GPs as a rationale for their participation in CHEMIST:

We’ve got a pharmacy right next to us, so we said that it would actually be quite a good thing for us to do, but also we realised that we can’t deliver all of this mental health support and things. The resources aren’t there in the NHS and we need to think about alternative ways of dealing with things.

However, for some pharmacy staff, the process of recruiting pharmacy customers to CHEMIST face to face seemed initially difficult to operationalise. One pharmacy staff member reported that pharmacy staff were ‘scared of what they were going to uncover’ (PS07) in the process of initiating discussions about a mental health intervention with their customers during the recruitment process. Conversely, discussions around physical health were thought of as ‘easier’ because they were seen as within the usual role of pharmacy staff:

I think it’s slightly easier to talk to someone about long-term conditions if it’s not necessarily associated with mental health, plus some of the feedback initially I got from the team members involved is that they were scared of what they were going to uncover.

Part of this apprehension was concern about managing risk, including suicide risk, with study participants:

I think initially they were a little bit unsure of themselves. I think mainly because they heard back from the intervention facilitators that the type of consultations that we were having would happen during the intervention and the fact that they had to talk a little bit more about mental health and about whether the patient had any suicidal thoughts and I think in the beginning they thought, am I going to have to have these kind of conversations at the point of recruitment? But then once they realised that that wasn’t the case, then they were fine after that.

The concept of risk management, which was covered in ESI facilitator training and an integral part of the ESI, appeared a difficult practice to embed, as the ESI facilitators saw this as far removed from their usual work; moving beyond these fears required reassurance and support from others, including the ESI clinical supervisors:

Well I got in contact with [clinical supervisor] and we spoke about it. Like that was fine. It’s obviously it’s just I felt out of me depth. Like I don’t think I could have helped kind of thing because I don’t have obviously no experience in anything like mental health or anything, so that was like the issue really. I didn’t think I could help them.

One pharmacy staff member thought that some of the initial anxiety about CHEMIST was in part because of some pharmacy staff not knowing what the ESI involved before they were put forward to deliver it:

I think the best way to manage it is to let them know exactly what it was before they were put forward.

In addition, some pharmacy staff raised questions about the compatibility of the CHEMIST ESI with their role:

. . . think amongst certain staff in the sense that, you know, the role has massively changed in recent years and, you know, we’ve got to do more and more things and why do I now need to do this?

However, those ESI facilitators who went on to deliver the ESI described how the process of delivering it allowed them to work through any initial discomfort and ultimately feel pride in delivering the ESI:

What I got out of it? Knowing that I’d helped these two people who, well one who I knew anyway but the [person] I didn’t know. How can I explain? As I say, I didn’t want to do it, I’ll be honest. I just did not want to do it in the beginning. I was sort of like, no this is what you’re doing, you’re doing it and I wasn’t happy. But now that I’ve done it, I’m so glad I did it because ‘em for what I’ve done for these two customers. Do you know I just find I’m quite proud of myself!

This was something that was also recognised by the general pharmacy staff who were not trained to deliver the ESI, but observed their colleagues doing so:

Yeah they all felt incredibly uncomfortable doing the intervention, but they were proud of it, you know, they were really proud of how much the patients had benefited.

Cognitive participation for study participants

Perhaps because of the relative novelty of the CHEMIST intervention in the pharmacy setting, study participants did not seem to have a strong sense of expectation on what taking part could mean:

I was very apprehensive and thought how daft is all this, but never mind we’ll go on.

Yeah just I thought maybe something could maybe help us, I don’t know.

One study participant described how they thought the CHEMIST intervention might benefit them by providing a ‘sympathetic ear’ and how it might ‘cheer them up’:

Yeah I thought it might cheer me up a little bit. Just have a break and have a talk to them. I’ve done some counselling myself over the years. I’m reasonably well qualified, so I wasn’t expecting an awful lot because as we went through it I’m doing most of the things that I can, so there wasn’t an awful lot that they can add really other than just a sympathetic ear which actually was quite helpful in itself.

Other study participants described feelings of altruism and reported wanting to help the health service:

My thoughts were I’ve received such a lot from the NHS, I was happy to do anything which might help.

Flexibility of the ways in which the ESI could be delivered was also discussed as a factor for continuing to participate in CHEMIST:

Well at the beginning I thought I don’t know if it would do us any good because I have a job getting out and things but [they] said [they] would speak to us on the phone if I couldn’t manage to get down. So yeah I was quite happy to do it because I did know I had odd days where I felt a bit depressed.

The degree to which confidentiality could be ensured in the pharmacy also appeared to influence how study participants felt about participation in the study:

It’s a slightly odd fit [pharmacy] but I think one of the things that I wondered about, they say you sort of get a lot of safe-guarding stuff within a [place] and you do wonder slightly when there are a lot of staff that are local whether you want to be talking an awful lot. It would be depend who the staff were I think and where you are. I’m not sure it would translate to every pharmacy.

For example, one study participant expressed how they were pleased that their ESI facilitator did not live locally, as they did not want to talk to local pharmacy staff who would then have information about them:

. . . but it’s a local pharmacy with . . . manned by local people serving local people . . . However, that’s the plus, the minus there’d be some people who think I don’t want to talk to somebody here because they’ll know my business . . . [Name] was a great choice because [they are] not local [they] . . . [they] doesn’t live in the [area].

General practitioner interviewees also raised the issue that the pharmacy may not be perceived by patients as operating the same rules of confidentiality as a general practice:

. . . suppose really there is an element of trust there and it can be something quite tricky. I mean at least the patient’s know that when they come into the GP surgery whatever you say within the four walls is confidential and that side of things I don’t know whether or not they class the pharmacy staff as holding that same situation, if you see what I mean, and I suppose really as well the concern if they said no or if they didn’t think it was successful or helpful then would they feel comfortable about going back to the pharmacy again in the future.

However, most study participants appeared reassured that the work with the ESI facilitator was confidential:

It’s personal. You can say things that you want to say, nobody else knows about it, just [name]. [They] writes things down, so to me that is good. It’s a good thing and you’ve got that bit of extra time.

In addition, one GP thought that familiarity with pharmacy staff might potentially facilitate participation in the study:

I think that for some patients there’s a pre-existing relationship with their pharmacist, um, and they, and they, they view that positively.

Furthermore, some study participants noted that it was the possibility of developing positive relationships with pharmacy staff that facilitated engagement with CHEMIST:

Well I thought it was good for anybody else that was, you know, really because I thought like if I had anything else to talk to him about I could obviously talk and get to know me pharmacist which it has done, you know, talking about them and I was really pleased that I did it.

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.

Collective action of recruitment to the pilot randomised controlled trial

Pharmacy staff at participating CPs received training via the study team on recruitment methods. This training appeared to be received positively:

Yeah the two [people] that came out, obviously some of it was on screen on the laptop. Obviously, we talked through everything on the screen as well and [they] went through everything, so it was really clear. Very clear, you know, dead easy to understand. Asked us if we had any questions. We actually discussed certain scenarios in certain circumstances where we’d come across things, you know, and they agreed with things we’d said and done and obviously interacted with each other. It was quite good actually, so yeah it was fine, it was great.

In addition, it appeared that following recruitment, training pharmacy staff had a clear understanding of the study recruitment criteria:

The recruitment part was quite . . . quite interesting because you had the criteria that had to be met, so, therefore, you knew what patients you were looking at so we could actually, actually implement our PMR [patient medication records] records . . .

Given the apparent simplicity of identifying potential participants through patient medication records (PMRs), it was initially anticipated by some pharmacy staff that the collective action required to recruit to the study would complement existing working practices:

. . . it goes back to kind of engaging the staff in the recruitment phase. I explained to them that it wasn’t anything that they weren’t already used to doing and what we were looking at was if you think about anyone that’s on long-term medication, they’re eligible for an MURs and we’d already identified patients MURs, so I said it’s only an extra identification that if you stick an MUR sticker on the bag then this person is eligible to be recruited for the CHEMIST study. So that engaged the staff straightaway because I wasn’t giving them any extra to do on top of their normal daily job.

Medicines use reviews were discussed as a potential opportunity for study recruitment:

. . . now those people are normally associated or the medicine is normally associated with the long-term condition that again fits in the criteria within the CHEMIST study and there are lots of opportunities of that, I can’t remember the numbers now but with new medicine service every time someone comes in with that it potentially opens a door to have a discussion with CHEMIST.

Other opportunities for recruitment included when customers attended for flu vaccinations:

. . . we linked it to the flu vaccination campaign and so when they were coming in they were sitting one to one with the pharmacist anyway, so we were able to . . . a lot of the people who were having the flu vaccinations were on the whole long-term medication as well, so it was a good way to link in with that as well.

However, for other CPs, having to consider CHEMIST was perceived to impede the work of recruiting to the flu vaccination programme. Thus, CHEMIST recruitment was not prioritised at the time of the flu clinic:

You can’t recruit for two services at once, so when we had to recruit for the flu vaccine unfortunately the CHEMIST study we weren’t able to recruit as what we had been because we had to concentrate . . . I find the staff can only concentrate on recruiting well for one big service at a time. So, if you’re having a massive push for flu for which we do in September then you can’t also be having a massive push for the CHEMIST study. It’s too much to do at the counter in a very limited time, if that makes sense.

Most participating CPs adopted the work of identifying potential pharmacy customers face to face as they collected prescriptions from the pharmacy:

We highlighted through the medication records who was suitable and then we would highlight it on the bag to have a word with them and explain that we were running a study, I can’t remember the exact saying we had but we had a little speech to say, you’ve been selected, would you like us to put some information in the bag? If you’ve got any more queries you can ask us; that kind of thing.

Some pharmacy staff described the process of approaching customers as compatible with their current practices:

No negative impact. It [recruitment] didn’t interfere with our day to day at all. We just merged it in with what we were doing normally every day anyway, so there was nothing . . . I didn’t have any feedback from anyone to say that it was anything extra on top of what they were already doing.

Others discussed how some pharmacy customers were dismissive of the study when approached face to face. This may have limited the success of face-to-face recruitment:

In addition, several pharmacy staff talked about knowing their customers; it appeared that some pharmacy staff preferred to approach customers whom they knew and already had a relationship with:

I think it’s just a general, er, relationship that the counter girls have with their patients, you know. I think, you know, they kind of knew the ones that were easier to approach, the ones that they wanted to give information to, who . . . who were a bit standoffish, and kind of used their own judgement of how they were, you know, giving the information packs.

One pharmacy staff participant talked about the context of the pharmacy as a place where some customers do not anticipate spending any length of time and how this could affect conversations about the study, which could impact recruitment and engagement with the ESI:

I think you’ve got to recognise when somebody is busy and they don’t want to have that discussion in the consultation room and if they do that’s great, I’d be happy to have it. But sometimes people just want to come in, you know, they’re parked on double yellow lines or they’ve got to go and get the bus and they just want their medicine very quick.

In addition, ESI facilitators thought that, when pharmacy staff were busy with the usual work of the pharmacy, the added work of face-to-face recruitment was not prioritised and did not take place:

I don’t know to be honest because obviously we’re really busy so it was like the whole, when you were labelling them all and putting CHEMIST study on it so that we knew to ask people and it was when you were busy, like remembering to do it and remembering to when you give it out to ask people and if you were busy you didn’t. So it was like time-consuming that way.

To ensure that customers were not approached about the study more than once, pharmacy staff were required to record the approach on the customer’s PMRs. This, again, affected the routine work of the pharmacy:

No it was just getting a system in place to flag patients’ records to say that they’ve had it before rather than keeping trying to, you know, ask the same patients every time, that we weren’t asking them twice, you know, the way we did that is we flagged it on their medication records, produced an extra label that went onto the prescription to say, you CHEMIST, so that when the lasses got to the counter they knew that they didn’t have to ask them again.

This additional work for pharmacy staff was reported as having operational difficulties, as some staff may forget to record an approach:

You see, I don’t know whether it was just the system we use or what but it was quite difficult to keep track of who we’d actually spoken to because quite a lot of people, like we wouldn’t have anything written on their records to say that we’d already spoken to them about it, but I don’t know whether that was just because someone who had spoken to them had forgotten to put it on their records; does that make sense?

In an attempt to increase recruitment to the study, pharmacy system searches (involving pharmacy staff posting out the study information to eligible customers) were implemented as an additional recruitment method (see Chapter 2). Pharmacy staff felt that they could give time to the postal mail-out only at quiet times in the pharmacy, and this was seen as an additional task that did not complement existing working practices. In addition, one pharmacy staff participant suggested that when postal recruitment was employed, face-to-face recruitment was sidelined:

. . . so we had multiple components to that, so one of the things we did was we identified people according to their medication histories to see if they would like to become part of it and we did that really through mailing the participant information sheet and that was very . . . it was good in a sense that we could do it when we were quiet in the pharmacy but I found that once we did that we took the focus of actively approaching people.

Although initially it appeared that individual recruitment strategies could complement existing working practices, the cumulative effects of numerous recruitment strategies could impede the working practices of the pharmacy. Thus, recruitment within the pharmacy could be difficult to embed and routinise:

I think it had a bigger impact on them is what they initially thought and initially it was let’s do it through the MUR process, right let’s add [unclear 11.46] process now. Let’s do it MUR, [unclear 11.44] and flu process and by the way [name] is now going to send you a load of data from your PMR search and [name] is going to send you loads of packs; let’s label those and send them all out. So I think the combined effect soon added up to quite an additional amount of workload that wasn’t there initially.

One recruitment strategy involved general practices conducting searches and posting out the study information to eligible patients. One GP who was interviewed reported that, owing to the study eligibility criteria including factors that are not routinely coded for in consultations, the process of having to look through lists of patients to assess patient suitability for the study was a burden to the practice:

. . . um, but this one, um, it, um, there wasn’t a prebuilt search, um, and, and, er, searching for each of the individual conditions was, was really quite huge.

Recruitment through home-delivered prescriptions was an additional method implemented during the feasibility study (as described in Chapter 5). However, one pharmacy staff member discussed how they did not have the opportunity to discuss the study with potential participants during the prescription home delivery process:

We weren’t going into as much depth in our home deliveries, but face-to-face customers who we were getting we were getting to speak to them a bit more. Whereas out on deliveries it was just our delivery driver taking them out, so you couldn’t speak to them as much.

In addition, some pharmacy staff did not perceive this method of recruitment as the most efficacious because they thought that they may have had less potential participant responses from home delivery recruitment:

I think we had a couple look at that, but quite a lot in the end we just never heard anything back from them really. Some of them just thought, I don’t know. I mean because we thought we were [unclear 14.21] quite a lot of them will be willing to like do it and things but I don’t think we really got a lot of response from the delivery ones.

Collective action of enhanced support intervention training for pharmacy staff

Given that delivery of a psychosocial intervention is fairly novel for the pharmacy setting, intervention delivery required ESI facilitators to acquire a new skill set by undertaking a 2-day ESI training workshop that was delivered by clinical members of the study team (see Chapter 2). Owing to the novelty of the ESI, it is perhaps unsurprising that this training was reported by ESI facilitators as requiring greater understanding than previous training that they had undertaken to deliver new interventions to pharmacy customers:

. . . because it was a 2-day training it was probably longer than we get for like other things in the pharmacy but it was . . . I think the training we get, like sometimes in-house training so we’ll have a course to do online, so it’s just like concise facts: this is what you do, this is what you do where. The CHEMIST was a lot more to take in, like understanding-wise.

A central feature of training for skill development in talking therapies, and for the CHEMIST ESI training, is the use of role-play. This was something that was reported by some ESI facilitators as a process that they found challenging:

Yeah sometimes I did find it [role-play] a bit intimidating to be quite honest, to think that I’ve been doing my job for that many years and, you know, I was trying to do this role-play which was totally like, you know, I just couldn’t grasp it, no.

Conversely, other ESI facilitators reported that role-play was helpful for skills development:

I think when we’re doing like the, er, like role-play and stuff like that, you know, that . . . that helps a lot, you know, how you would . . . and [name], like [they] role-played with us as well, and you know, made us think, and you know, gave us like words and you know, phrases to use and everything. And that . . . that . . . that helped an awful lot.

Following the ESI training, ESI facilitators were required to complete a telephone-based competency assessment to evaluate if the training had equipped them with the skills and knowledge required to deliver the ESI. This process was reported as inducing some anxiety in the ESI facilitators and required additional work outside the training workshop:

. . . think there was impact on the staff in terms of when they were going through the training. Staff were certainly anxious around the training and the assessment, the assessment in particular. I know staff were taking their, you know, their training materials home to read through in preparation for their exam the next day . . .

Overall, it appeared that the ESI training was reported positively in providing the ESI facilitator with the skills to deliver the ESI, and some ESI facilitators reported that training helped them to communicate with pharmacy customers more generally:

No, I think it all went well in general, you know, it was, er . . . it was like, you know, easy, you know, to . . . to listen to and, you know, easily explained and everything, so you know, I think it all went well.

However, it was noted that the ESI training took place some time before some ESI facilitators began to work with study participants:

The training was obviously the last time I had training was [month] last year and afterwards I felt quite motivated to do it but because we didn’t start for a while after and I didn’t get anybody recruited for a while after.

The ESI training affected the usual work of the pharmacy to the extent that other pharmacy staff needed to cover the work of the ESI facilitators when they attended the ESI training, with staffing in the pharmacy requiring a resource reallocation:

Umm, no, just really, like, a time point of view when [name] was taken out of the equation obviously for sessions or retraining and that . . . that was the only thing.

In addition, ESI facilitators reported needing to plan in advance when they could deliver the ESI sessions. This was carried out to mitigate the impact of them being taken out of their usual role in the pharmacy. The most appropriate times to deliver the ESI were reported as quiet times in the pharmacy or when additional staff could be present:

I think if you’d seen our branch, we only have at any one time there’s only three of us in, so say like today, there’s me, the pharmacist and another dispenser in. If we, say if I had two or three CHEMIST [participants] in today, it might put a bit of a strain on it. But then, well actually on a [day], we normally have four people in so I tended to try and keep the appointments for a [day] where I know we’ve got more staff and it’s not going to become, ‘oh God [they] in there for ages again’, because that can happen.

To ensure privacy the face-to-face ESI sessions required the use of the pharmacy consultation room, and some pharmacy facilities were limited to one consultation room. Thus, if ESI facilitators were using this room for CHEMIST participants, this prevented its use by other pharmacy customers who might wish to speak privately with the pharmacist, for example. Thus, delivery of the CHEMIST ESI could affect the usual work of the pharmacy:

. . . just a very minor thing, these things tend to happen in the consultation room of the pharmacy and sometimes they might have tied up the consultation room a little bit. So if somebody was having a 30-minute consultation with somebody and then somebody else wanted to come in and they wanted to talk to the pharmacist, they were kind of unable to but that was only very minor thing.

In addition, some pharmacy staff indicated that not all staff were involved in doing the work required to support CHEMIST:

When, because I think somebody came into branch and spoke to the other girls about the CHEMIST study, so maybe at that point say, you know, you can all help with the admin and giving the packs out, sending the faxes out, sort of thing. I mean I wasn’t here when that talk happened, so that could have happened.

Collective action of the intervention for participants

This section describes the actions required by study participants to enact the CHEMIST intervention.

Study participants who received the ESI described participating through a number of routes. Many talked about being recruited to CHEMIST via a letter from their GP:

. . . but I mean yet again I’ve always been one that don’t argue against doctors unless you know what you’re talking about and if the doctor says you should do that, I do that. So there’s no argument. I wouldn’t query it. I would follow it through because we pay them to look after you and if you do exactly what you’re asked to do then you can go and knock on the door.

Other study participants discussed being recruited by pharmacy staff:

I went to the chemist and I can’t think, is it [name]? I think they call the [person name] and they were asking people if they would participate in this study by the pharmacy and I can’t exactly remember who I spoke to but it could have been [name] because nobody was agreeing to do it, so I said, yeah I’ll do it. I’ll give it a go and that’s how it started.

In addition, participants reported that they had read the advertising materials displayed in the pharmacy:

With regard to mode of delivery of the ESI, it was planned that initial meetings would be face to face in the pharmacy, after which time the participants would receive the ESI over the telephone (as described in Chapter 2). Although some participants received the ESI this way, others preferred to receive the entire ESI face to face, which was accommodated by ESI facilitators:

I guess it was more convenient [face-to-face delivery] and also I think perhaps she would get a better understanding of some of the things I would say because [they] could see how I looked.

In addition, sensory problems sometimes prevented study participants from speaking to the ESI facilitator over the telephone:

Because if they’re on the phone I can’t hear. Left ear I’ve got a hearing aid and a clef pallet and that’s damaged the left ear altogether and right ear has gone because of using chain saws and everything from the noise.

Furthermore, some study participants discussed how attending the pharmacy was a method of treatment in itself:

Getting out to the pharmacy, making yourself get ready and go out to the pharmacy and come back. I used to go to the shops and feel like a new [person] when I came out.

However, one study participant who received the ESI face to face, but then needed to switch to telephone delivery, reported that as they then needed to call the ESI facilitator, they could not always reach them at the allocated time:

Face to face if I’m honest because the telephone ones, [name] the [person] who was doing the interviewing I would have to ring [them] because [they] was busy and [they] didn’t get chance to ring, so I just felt, what’s the word I’m looking for? Slightly put out, shall we say, where when I went to the pharmacy to do the face to face it was easy, [they] finished whatever [they] was doing and then we did the interview.

In addition, although one study participant had arranged to receive the first ESI session in the pharmacy, they described arriving for their first session and finding that the expected meeting was not known to the general pharmacy staff:

Well I went in and nobody knew anything about it and after sort of about 10, 15 minutes they realised it was this particular [person] who wasn’t there, [they’d] either gone home sick or taken somebody sick and I sat for about 40 minutes waiting for [them] to turn up and [they] didn’t turn up. So in the end I just said, look I’m going home. I’m not really well enough to sit here waiting but nobody in the pharmacy really knew what it was about and I never saw anyone.

This study participant later decided not to participate in the ESI sessions, citing the young age of their potential ESI facilitator as an additional reason for their decision not to participate. Subsequent discussions with the pharmacy suggest that this situation was down to communication issues within the pharmacy team.

Engagement with the ESI involved study participants speaking with the ESI facilitator up to six times and working through the ESI self-help workbook, supported by the ESI facilitator.

The self-help workbook was reported as accessible and understandable:

It was quite nice to have a booklet that sort of said, right, OK, these are strategies, try these strategies and think about, and it’s something that I’ve kept it and, you know, I think what I’ll probably do every now and again when I’m feeling really miserable, I’ll look through it and go right is there anything that I could be doing here?

One study participant reported that the workbook contained ‘too much information’:

But my observation was there was too much information, do, you know, it could have been simpler to my mind.

However, most study participants completing the ESI described the workbook as being of use and being used:

Right, well the first thing we did was to read all the literature and discuss that with this lady at the chemist, who was excellent, absolutely excellent.

We kind of went through, there was a structured booklet wasn’t there and we kind of went through that and what I was doing at the moment. It does make you take a step back and think actually what am I doing? Am I doing all that I could be doing?

Study participants also discussed how the interaction with the ESI facilitator involved talking and being listened to:

We just talked and she explained why I was there and I said, yes I understand that I’ve come for a talk and, you know, I opened up and told her why I’ve got this anxiety and why I don’t think it will ever go and, you know, she was very, very helpful and listened.

Participants described the workbook and speaking with the ESI facilitators as helping them to make links between activity and mood, and understanding the underlying theory of BA:

I’ve got this to do, I’ve got that to do and you just do them without really thinking about what makes you feel better and when she was sitting there and sort of saying, right OK, how are you feeling this morning? How are you feeling? Why are you feeling better this morning? Why are you feeling better this evening? It’s because I walked the dog and I think that was the most useful thing that came out of it . . . My mood is better.

The diary in the workbook supported study participants to monitor the links between mood and behaviour:

. . . I think it was doing the diary, it really made me realise that I wasn’t doing certain things as often as I used to and it made me more conscious of them.

The diary also supported action-planning:

She had half an hour and we discussed everything over the half an hour. There was no panic, you know. But we did fulfil the half-hour chat. We didn’t just say, oh I’m alright today, no problem, I feel a lot better. We didn’t. We made it into, what’s the word I’m after? An action plan.

Most study participants reported the number of ESI sessions that would be suitable:

I think we did enough with six. I think what it was, it was the same questions and I thought to me self, can’t just keep going over the same thing really [unclear 28.16] . . . if I wanted anything, I could always come in and see [them].

Conversely, one study participant discussed that they would have liked more sessions to embed their learning:

I thought for long-term change, 6 weeks only just identifies sort of areas I think for longer-term change. You need longer.

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.

Reflexive monitoring of pharmacy staff, enhanced support intervention facilitators and general practitioners

It appeared that a central way that the pharmacy staff appraised the ESI was through its observed effects on the study participants who had received it. These observed effects appeared to be collectively appraised positively in some pharmacies:

I’ve heard really good things, so the pharmacy in [place] definitely said to me that they’ve seen the patient transform. I think I was explaining to you earlier, they’ve gone from someone with no confidence whatsoever, quite low mood, and they then started doing the intervention because the patient was successful and they’ve now seen the patient, you know, a completely different person. Very confident, changed their looks as well, even appearance looked better as well, involved in the community and they couldn’t talk enough good about how they’ve seen the transformation.

As well as observing the positive effects of the study on participants, one ESI facilitator described how a participant who they had worked with over the telephone had attended the pharmacy following the conclusion of the ESI to express their thanks:

Yeah. [They] said to me, I can’t come in, [health reason] and that sort of thing, and about 2 weeks after the study had finished [they] came in to see me and I’d never met [them] the whole I’d done it and [they] said, do you know who I am? I said I do actually, and [they’d] come in. I’ve come in to thank ya. I was like wow!

These interactions would have provided positive feedback to pharmacy staff/ESI facilitators and reinforced the NPT domains of cognitive participation and the coherence of CHEMIST. In addition, positive appraisal of the benefits of the ESI was described as validating the NPT domain of collective action required to operationalise the ESI:

. . . also we started to see on the back of the interventions that the girls did, we saw a difference in those people after they’d finished the 6 weeks, and I think if I was to talk to all the girls, I know we mentioned it briefly between ourselves around the time we were still doing the study, that we felt good about what we had done even though I think it was only two people, but we feel like we made a difference for those two people and that kind of validated what we were doing as well.

As well as the benefits observed for study participants, some pharmacy staff talked about the increased confidence that they had gained through exposure to the study, such as recognising signs of low mood in other customers and subsequent consideration of how they interacted with them:

Obviously seeing the effects of the CHEMIST study it was quite beneficial really to see how we could help people and obviously, you know, help other people as well in the experience you have and the confidence you get to speak to people and obviously helping other people over the counter to even recognise that sign and recognising when someone is a bit low and even just an odd word or an odd smile sometimes can help, so it was quite good.

Furthermore, some pharmacy staff and ESI facilitators described how a benefit of their involvement in CHEMIST was that they had gained skills in mental health. Some staff spoke about how perceiving themselves as helping others offered personal reward:

The chance to help someone for me. Just to help somebody feel better. It was just a fab opportunity to be able to get some knowledge around this subject and just like, as I say, put things into place to help people because to me if I’ve made someone happy I’m the happiest person going [laugh].

Another pharmacy staff member discussed how the CHEMIST intervention had added value to their practice by allowing them to view their customers more holistically:

So I felt that it added a lot of value to my practice and it helped me kind of remember that these people that we see day in days out, that they have a lot of other things going on in their lives aside from their prescription, which is mainly the reason that they would come to see us, and it kind of reminds you that it’s a person you’re dealing with and not necessarily a patient.

However, some ESI facilitators who had not delivered the intervention appeared to attach less value to the study:

The emotional burden of delivering a mental health intervention was acknowledged by one ESI facilitator. However, they appraised their overall experience of delivering the ESI as positive:

Yeah I mean there were a couple of times after they’d gone, after they went, I came down in the [place] and I had a few tears because I was like, oh my God these people. But, no, I’m quite proud of myself. I’m so glad I did it. So glad I did it.

Several pharmacy staff reflected that delivering a mental health intervention from the pharmacy was a novel enterprise and that this required a change in perception about the role of the pharmacy, for both pharmacy staff and customers. Customers who participated in the ESI generally appeared to be accepting of receiving a talking therapy via the pharmacy or, in some cases, over the telephone. However, it was acknowledged that those customers who did not participate in the study may have thought differently about the suitability of the pharmacy as a place to deliver a talking therapy:

I think really the main barriers would actually just be down to the customer themselves. There is still a certain type of customer that it doesn’t matter what you want to discuss with them even if it’s something that’s going to benefit them, they’re not interested and there’s always going to be that for anything that we try and do in the pharmacy.

As discussed under Cognitive participation, issues around confidentiality and customer familiarity with pharmacy staff, particularly in smaller communities, were cited as a potential barrier to participating in CHEMIST:

The other thing is that somebody coming in as the client or patient or whatever you want to call them, there . . . there has to be an element of trust and part of that element of trust is that the person sitting on the other side of the table knows what they’re doing, and in a way, it needs to be somebody who is distant from them.

Concerns around customer familiarity with pharmacy staff delivering the ESI were also recognised by some pharmacy staff. A potential solution was offered that participants could choose which pharmacy they received the ESI at:

If you’re a patient that goes to the pharmacy day in and day out, it may be that you don’t want to go to the pharmacy for the intervention. You may want to go to another setting, so you may want to go to, I don’t know, another pharmacy or GP practice or no pharmacy at all.

In addition, one study participant expressed concern around maintaining privacy regarding the reason for attendance at pharmacy when receiving a mental health intervention:

I think maybe possibly privacy, but that’s something that you would work out if you were doing something regularly. You wouldn’t want to be saying to somebody, umm you can come into the room for your, I don’t know, your counselling session or whatever. You’d just have to be a bit careful how you worded things . . .

Study recruitment materials were also discussed as an area for potential modification. For example, some pharmacy staff suggested that the length of these materials could be reduced:

I think because when you see the paperwork it is quite lengthy, there’s quite a few pages for the patients to read and I think when you go home, I think some people don’t bother. They don’t bother looking at it but obviously when the patients have read through and thought ah yes, and filled it in and sent it off but not everyone is going to read it because it’s quite in depth isn’t it. It’s quite a lot to look through and if patients are taking it away, obviously we don’t have time to sit in here and go through each one with the patient; that wouldn’t be feasible.

The language of the recruitment materials was also highlighted as an additional area for future consideration by one GP interviewee:

. . . and I think that, um, it’s recognised that health-care professionals often . . . even when they’re trying desperately hard not to use the jargon, use a vocabulary that is not always clear.

Some pharmacy staff raised the problem of increased workload that was related to recruitment activity; when this work did not result in participant recruitment, this was found to be demotivating:

So if we had any further referrals through to the service, that would have been better. It’s just a bit demotivating when you’re not seeing any positive outcomes in the end apart from at the very, very final end.

Allowing pharmacists to be trained in the ESI was highlighted as a potential modification because it was felt that this would allow pharmacists to potentially better support the ESI facilitators and complement existing working structures:

If I had the opportunity to have the same training as the intervention facilitators I feel I could have supported them through what they were doing a lot more because I was reading all the information that they had been trained on and they had the verbal training as well, so I felt I would have taken in a lot more that side a lot better if I was at the training.

Finally, pharmacy staff participants discussed how the study would need to consider relevant pharmacy funding and staffing were it to be rolled out further:

I don’t know if this study was funded to an extent for the interventions or be it in a sort of roundabout way but I think that if it ever had to come back to pharmacy I think it needs to be appropriately funded and recognise the really important role that team members play in the management of the person’s holistic health, so their long-term as well as mental conditions as well.

Reflective monitoring for study participants

Study participants who had completed the ESI repeatedly offered positive appraisal. For example, positive changes in mood and behaviour were discussed:

. . . it’s funny how something you can read to make you realise, you know, you’ve got to change a thing and I have actually, I have. People have remarked I’m looking better to what I used to, so that makes you feel good as well.

For many study participants, the relationship and support of the ESI facilitator was an important ingredient of the ESI’s success:

I’ve established a lovely relationship with the one who helped me, we got away from the abyss because it either sounds dramatic, I knew I was going down and down and down and I’m now going up and up. I can’t go too far, me legs won’t take it, but never mind!

Yeah at the time it was, as I say, when I was relaying my mood there was encouragement from this particular [person], you know, ‘that’s good, do some more of that’, you know, that was good in regards to the whole exercise.

Numerous study participants discussed that they specifically valued how the ESI had offered up a space in which they could evaluate or consider the relationship between their health condition and their mood:

Particularly with [health condition] you tend not to talk to people because it becomes boring after a while because it doesn’t change. It doesn’t get any better and other people kind of want you to get better. It’s like, oh are you feeling better today? Actually no I’m not and I won’t, you know; if anything I’m not going to get any better. So it’s getting your head around that and going, how much am I going to let it get me down?

These benefits were also reported for study participants who had received previous psychological treatments:

. . . we had some very interesting conversations and [they] did say at one stage, with your experience do you find these of any use then? I said, well, yes, because what it’s doing is it’s giving me a chance to, err, to evaluate where I’ve come.

Most of the changes that were reported as a result of the ESI were in mood:

Not so many physical changes I would have said but more mental changes at saying, right, actually, you know, up with this I will not put.

However, one study participant reported no changes despite completing the ESI:

One ESI non-completer who completed two ESI sessions, but subsequently decided not to continue with the ESI, described the ESI as not making a difference for them:

As discussed in Collective action, study participants generally appraised the self-help workbook positively. In addition, study participants discussed how the study had influenced how they would use the pharmacy in the future, suggesting that they would seek help and advice from the pharmacy, a practice that could reduce burden on primary care:

Yes because [facilitator] has opened up and said, you know, if I need to go back and help with my mood or anything, she’s more than willing to do that and I think if I started feeling down again that would be my first port of call. Now whether if [facilitator] moves on, I don’t know what the position of the other staff would be, but it would be me first port of call.

Chapter summary

This qualitative evaluation has presented the perspectives of study participants, pharmacy staff, ESI facilitators and GPs, analysed through the interpretive framework of NPT.81 The use of NPT allowed for a theory-driven evaluation of the pilot RCT study processes. For example, it appeared that reflexive monitoring of the positive effects of the ESI for pharmacy customers promoted both coherence and cognitive participation for pharmacy staff and ESI facilitators. Gaining confidence in using the skills acquired through the ESI training appeared to promote coherence and cognitive participation for ESI facilitators. Increased cognitive participation and coherence would have theoretically positively promoted the collective action of the CHEMIST intervention.77 However, some ESI facilitators who did not deliver the ESI reported less positive reflexive monitoring, which could theoretically have reduced their coherence and cognitive participation of the ESI. Once the ESI was operational, the collective action, or work of the ESI itself, seemed to have the potential to be embedded and normalised in the pharmacy setting, provided adequate facilities were available and privacy and confidentiality concerns were addressed. However, a primary factor that appeared to inhibit the normalisation of CHEMIST appeared to be the collective action involved in recruitment and the prohibiting effect of this practice on routine pharmacy working.

Most study participants who completed the ESI reflected on subsequent positive changes in mood and behaviour that appeared important and significant to them, although fewer perceived benefits were reported by ESI non-completers. In addition, study materials were generally well received and used by those who completed the ESI. In addition, the role of the ESI facilitator was seen by some study participants as central to the process of supporting the ESI. This was a relationship that they appeared to value highly and most likely promoted coherence, cognitive participation and overall study retention. However, for some study participants, familiarity with the staff who they encounter in the pharmacy may have prohibited participation in the study, owing to concerns about the privacy and confidentiality of the pharmacy. In addition, although participants who entered the study had few expectations about the study, it is not known how coherent other pharmacy customers might find the prospect of receiving a mental health intervention in their pharmacy setting. However, given that CHEMIST was the first study to evaluate the delivery of a talking therapy in the pharmacy setting, it is perhaps to be expected that issues around coherence, related to the novelty of the study, are to be expected.

This qualitative work has benefited from a range of perspectives obtained from across participant groups; however, the views of the ESI non-completers and GPs are less well illuminated because of their smaller numbers in the interviewee sample. In addition, the application of NPT has provided an established theoretical framework in which to interpret and elucidate pilot study phenomena. However, criticisms of the use of the theoretical framework in qualitative data analysis include the possibility that alternative themes could be occluded if they are applied too rigidly. In the CHEMIST pilot data, however, the NPT framework provided a conceptual theory to sensitise the data analysis, rather than constrain the inductive development of categories during the process of constant comparison.69 Thus, a thorough exploration of the pilot qualitative data was possible within the NPT framework.

To promote the normalisation of the ESI, future work could explore potential issues around the coherence of receiving talking therapies in the pharmacy setting for pharmacy customers. In addition, consideration of if smaller pharmacies would have the available facilities from which to deliver the ESI to larger numbers of study participants would be needed. In addition, training non-ESI-delivering pharmacists in the ESI could complement existing pharmacy working structures, promoting ESI normalisation.