Phase I: the ethics test
We obtained a favourable ethical opinion from the HRA’s National Research Ethics Service Committee East Midlands – Nottingham 1 Research Ethics Committee (REC) after receiving advice from the committee to submit for ‘Proportionate Review’. The Proportionate Review Service receives applications from research studies where the ethics committee believe that there is minimal risk, burden or intrusion for research participants and consequently applications are reviewed by a sub-committee rather than at a full meeting of a REC. The process of obtaining a favourable ethics opinion for the DiReCT study took 2 weeks from submission by this process (Ref 12/EM/0326). The sub-committee lead reviewer sought a telephone conversation with the Chief Investigator to clarify details of the application, during which there was an acknowledgement by the reviewer of the importance of improving trial recruitment, given that many ethics extension applications to RECs are a result of study recruitment difficulties. The reviewer raised no concerns about our intention to invite patients to pre-consent to randomisation as part of our hypothetical feasibility test, nor to the overall principle of our consent procedures should trials actually be running in any future cmRCT.
Phase II: the recruitment and trials test
The clinical service assessed 1,240 people during the 4 months of the DiReCT study, of whom 752 were offered treatment for depression and anxiety problems and were thus eligible for participation. All 752 treated patients were posted study information in advance of their first assessment. The clinical team obtained consent or decline data from 131/752 (17%) of potential participants during the study period. Of these 131 people, 47 (36%) declined to participate. Of the remaining 84 (64%), all participants consented to be contacted by a researcher, 83 consented to their medical records being looked at by researchers, and 83 consented to being randomised into future trials.
When contacted by the research team to confirm consent, 71/84 (85%) of participants consented to having their medical records included in research and 69/84 (82%) consented to be offered randomly allocated active treatment procedures in future unspecified and at this stage hypothetical clinical trials. Five out of 84 (6%) people decided against participation and we were unable to contact the remaining eight (10%).Figure 1 summarises the flow of participant recruitment where 71/752 (9%) of the total number of patients who were offered treatment during the study period consented to take part and 69/131 (53%) of all patients who were invited by a clinician to take part consented to be offered randomly allocated active treatment procedures.
There were no differences between included participants in age, gender, employment and depression severity (Table 1) when compared with the total number of people treated by the service during the study period, although there was a trend towards our included participants having a greater severity of depression.
Twenty-one clinicians were involved in the initial consent procedure: 14 senior therapists and seven PWPs. Sixteen clinicians were full time and five part-time. Table 2 details recruitment patterns by grade and hours worked.
Qualitative interview data
We interviewed nine of the 21 clinicians who were involved in the DiReCT study (four therapists and five PWPs). All clinicians who were asked to take part in the interviews consented. Our analysis aimed to describe the views of clinicians about the process of routinely recruiting and consenting patients into the DiReCT study. Our results showed that their views could be understood in terms of four themes: ‘working with patients takes priority’; ‘workplace systems and pressures of daily work’; ‘clinicians’ views of the DiReCT project and of research; ‘clinicians’ perception of patients’ reaction to the recruitment process’.
Working with patients takes priority
The theme ‘working with patients takes priority’ describes the difficulties clinicians could experience in balancing their existing clinical practices with the recruitment process for the DiReCT study. The theme covered both their views on having to meet the patient’s needs in general, especially those patients in great distress, together with the importance clinicians ascribed to developing a therapeutic relationship.
In terms of meeting patients’ needs, clinicians described that they would only carry out the consent procedure provided their clinical priorities had been attended to first. Such priorities focussed on meeting patients’ immediate mental health needs. Introducing the DiReCT study was described as getting in the way of devising a treatment plan and delivering the therapy. Treating the patient's problems was viewed as a greater priority for clinicians than inviting them to take part in this study. They described having to make prioritisation decisions on when to introduce the topic of research participation - for example, at the second appointment when patients could be less anxious or even at a later appointment when clinicians were monitoring patient progress rather than introducing new clinical techniques.
“I was constantly trying to weigh up, you know, should I let this go or, what’s in the patient’s interest in this case? Should I pursue it or, let that go and focus more on the treatment and coming up with the rest of the plan?” (PWP 5)
“I think a lot of the time it was very, very difficult to do it… see, it was easier to perhaps broach it right at the beginning at the assessment, or, umm after you’ve had a few sessions because then, there was less going on”. (PWP 2)
In some cases clinicians described how they had to support patients who were in distress as the major focus of their sessional work for these patients. This was particularly the case when clinicians were interviewing patients in great distress, where the focus of their clinical work was very clearly directed towards responding to and helping the patient manage their distress. Introducing the study to distressed patients was described as making the clinicians feel uncomfortable. One clinician explained it as:
“I think… if someone is extremely distressed then… it’s not the first priority at that point when someone is in distress or upset… it wouldn’t feel comfortable at the end of an appointment that had been clearly very emotionally difficult for a patient to say, ‘Oh and by the way, can I just have a talk to you about this whole other thing”. (PWP 4)
Furthermore, in this theme the clinicians described the importance of the therapeutic relationship between themselves and patients. They expressed concern that introducing the DiReCT study would get in the way of developing this relationship, particularly at the early stages of their therapeutic work with patients.
“Having another element, right at the key point when you’re doing that relationship building with people… and you already feel like you’re not getting enough time to talk to them about what’s bringing them, and how they’re feeling at times…” (Therapist 1)
Workplace systems and pressures of daily work
The theme ‘workplace systems and pressures of daily work’ describes the experience of organisational prerogatives on clinicians’ daily work and how this affected their ability to recruit patients into the DiReCT study. This theme covered descriptions of workload targets and resulting time pressures, clinical roles in the team and administrative systems.
In regards to workload targets and resulting time pressures, clinicians described how high volumes of patients and short appointment times could make it difficult to fit the recruitment procedure into an appointment. One of the issues described in this theme was the clinicians’ concern over how to find the time they believed they needed in order to participate in the process of recruiting and consenting patients into the study. As one clinician expressed it:
“We’re so pressured with targets to get, you know, see so many people a week… and have 30 minute sessions, and then it’s sort of one after the other, you’ve barely got time between each session to even reflect. That adding anything else onto it… was very pressured.” (PWP 2)
Clinicians’ description of the recruitment process also included their views on the roles and responsibilities of different clinicians in the team. When it came to describing this, senior clinicians in a ‘high-intensity’ therapy role outlined how difficult it could be for them to recruit patients during the first few appointments, as they described being less familiar with this assessment role, ordinarily undertaken by PWPs. At times, because of staff shortages, senior therapists provided substitute cover for PWPs. In these circumstances, they described how not consistently seeing the same patients at follow up appointments could make it difficult to carry out the recruitment process if they had not been able to do so during the first appointment.
“Because we have an issue with the high attrition [of PWP’s], we’ve had a lot of [senior therapists] doing assessments, then put them on the waiting list for a PWP to pick up… so when the PWP picks up the person it might be a month between the assessment and the follow up, so they’ve got to… check the problem statement’s the same… and it’s a bit of a mini reassessment, so that takes time… they’ve also got to start some therapy, and then they’ve got to spend eight minutes going through the study… they were struggling to get all that in”. (Therapist 3)
Furthermore, within this theme of workplace systems and pressures of daily work, clinicians reported that the impact of different working conditions could in their view impede their ability to fit the recruitment and consent procedure into their appointments. For example, they described how a lack of equipment and record keeping systems could make it difficult to remember to invite patients to take part in the study.
“We had this, umm, additional new clinical space that they’d purchased for us upstairs, they didn’t have any IT and didn’t have any phones… so actually… what happened with that was it made it quite difficult… to err, remember when somebody was on their second or third or fourth session that was quite tricky…. and that meant that sometimes people were missed”. (PWP 5)
Clinicians’ views of the DiReCT project and of research
In the theme ‘clinicians’ views of the DiReCT project and of research’ the way clinicians viewed both research procedures specific to the DiReCT study and their perceptions of research in general were reflected.
In terms of clinicians’ experiences of the DiReCT project, they described how the complexity of the DiReCT recruitment and consent process and the amount of paperwork required could make it difficult for them to present the study to patients, and that having less of a role in the procedure would have been easier for them. It was felt by some clinicians that researchers should carry out informed consent and that clinicians should only have a limited role - for example, in collecting ‘consent to contact researcher’ forms from patients. A less involved role might have persuaded clinicians to approach more patients. The hypothetical and pilot nature of the DiReCT study was also viewed as a reason why clinicians might choose not to try and recruit some patients, given that recruiting patients would confer no tangible benefits to their patients.
“I’d have been quite happy for someone to ask people, you know, to bring me something and if they bring it to me, just tick say, ‘I’m interested in more information on this, but I’m not signing up to anything right now’… I’d be quite happy for that and then let the research team talk about it with them or something because they know what’s going on better than I do… so it’s just a little bit more streamlined so we have less of a role in terms of explaining”. (PWP 1)
“As far as I was aware it was almost like a pre-test to, pre-research so it wasn’t actually kind of… as far as I was aware it wasn’t actually counted towards anything so again it was a bit confusing”. (Therapist 4)
Clinicians described generally positive attitudes to research and how having experience of research in general could contribute to a positive attitude to the DiReCT study. Again, this could reflect the way that clinicians viewed their role in research, in this case a more general attitude to research per se. Having a background in research was described as being useful in helping clinicians feel more competent in carrying out the procedure, which some clinicians viewed as getting easier with practice. A positive aspect of the DiReCT study was that it was viewed as possibly helping to contribute to future quality research, which was described as important.
“There were some things which I had liked about it because I do think it is important that we get umm… you know, umm… lots of people to make really robust, umm… research papers written umm but, so that was the good bit, that was me, sort of quite liking that aspect of it”. (PWP 1)
‘Clinicians’ perception of patients’ reaction to the recruitment process’
The theme ‘ clinicians’ perception of patients’ reaction to the recruitment process’ contained descriptions around how patients reacted when the clinicians approached them in regards to the recruitment and consent process. The theme also covered ethical concerns around the validity of consent consequent upon interpersonal interactions reported by clinicians.
Clinicians described how it could be more difficult to recruit certain patients. They were less likely to invite patients to participate in the DiReCT study if he or she displayed characteristics, views or behaviours that were viewed as not conducive to the recruitment and consent procedure. One clinician described it as:
“We have a bit of an issue with err, angry men… so, umm who, we’ll have some people who come in quite angry and they don’t want to fill the MDS in so, if they’re saying ‘I really-, I’m not filling this in’, err and they’re quite confrontational… then we’re not going say ‘well can you fill-, can I spend eight minutes to discuss this with you as well?’” (Therapist 3)
In this theme the clinicians additionally described that there was a distinct divide in attitude between those patients who were willing to consent and those who were not willing. Clinicians described how they were more likely to follow through the recruitment process with patients who showed an apparently positive attitude to the study already. For example, some patients would attend appointments having made their decision to participate in the DiReCT study prior to attending their assessment, in that they brought the consent form already signed to their first appointment.
“Yeah the people, that was quite distinctly the people that, umm, did want to do it, it was quite obvious, the people that did… their view was ‘Ooh yes, we need something like this, I’ve read it through, and’ …oh yeah, I mean the people that wanted to do it had read it all the way through, the people that didn’t want to do it, a few of them had read it through and didn’t see the point, and a few of the others had been put off by it and sort of thought ‘I don’t wanna do this”. (PWP 3)
Patient characteristics as perceived by clinicians also affected their decisions over whether to offer participation - for example, low levels of patient literacy which could lead clinicians to doubt patient comprehension. Clinicians also reported their perception that those patients with more severe depression were less likely to consent to participation. Some clinicians described feeling confused about the eligibility of newly referred patients who wanted to take part but were not eligible for treatment by the service.
“It was quite tricky when… if they’d received it in the post and they had got enthusiastic about it but then I’d deemed them not suitable, because they weren’t suitable for our service, that was a bit difficult”. (PWP 5)
The ethical concerns perceived by the clinicians were mainly described as reflecting the validity of consent consequent upon interpersonal interactions between clinicians and patients. Descriptions covered how the clinicians questioned the validity of consent from patients who did not appear to fully understand the DiReCT study. It could become apparent for the clinicians that the patients had signed the consent form without fully reading the patient information sheet. One clinician described it as: “I mean ‘fully understood’ is pushing it in some cases, I mean some of them told me they hadn’t read it, they’d just signed it” (PWP 1). These kinds of situations were described as making the clinicians feel uncomfortable about forwarding their consent forms to the research team.
“I had a couple of people that… had come in, signed it all and I just kind of checked it out and they said ‘Oh I just signed it, I don’t really care, you know I just want to get on with this’… so I wasn’t quite sure what to do with that really that they’d signed it, they said ‘yes I’m consenting’, but… when I’d come to explain the bit about the study, they really weren’t interested”. (Therapist 3)
Further, the theme also represented descriptions concerning the interpersonal relationship dynamic between the clinician and patient, where the clinicians perceived that they were unintentionally endorsing the DiReCT study to the patients. Clinicians also described how the power dynamic within the therapeutic relationship could make discussing the study with patients make them feel uncomfortable.
“I was also concerned as well about the kind of the, power aspect of the relationship as well you know, I was awfully aware that, you know, with the best will in the world, we always try not to be in a position of power, that’s part of the role but, you are… umm and asking someone to go away and read this thing, explaining… why it’s important or why it’s being done… you’re kind of, endorsing it, you’re kind of saying this is something that’s good, ‘it’s your choice’ but ‘it’s good’… and it just, it feels a little uncomfortable”. (PWP 1)