Following thematic analyses of ethnographic observations and focus groups, it seemed that there were several key recruitment barriers encountered by the research team during the process of recruitment to the trial. Beyond simply listing recruitment issues, trial staff discussed how these issues were addressed and what work was done to best negotiate these issues. In order to frame these discussions as distinct from merely reporting key issues, the concept of trial work (54) was utilised within a qualitative framework analysis (55). Trial work is a broad concept related to the work done to overcome barriers during the recruitment process engagement, ‘buy in’ to the trial across a range of stakeholders as well as work involved in managing the organisational complexity necessary to reach recruitment targets (54). Trial work appeared highly relevant to the aims of this study in terms of maximising learning and understanding from the EMPOWER recruitment process. The reporting will highlight the key recruitment barriers and then the trial work utilised to facilitate recruitment.
Key Recruitment Barriers
The key barriers described by trial staff into trial recruitment broadly fell into three main themes; service characteristics (lack of time available to mental health staff to support recruitment, staff turnover, patient turnover (within Australia only), management styles of community mental health teams, physical environment) and clinician expectations (filtering effect and resistance to research participation)
Service Characteristics
Lack of Time available to Mental Health Staff to Support Recruitment
Research trial staff frequently spoke about mental health staff not having much time to engage within the recruitment process. The research team were highly aware of the broader social context of low staff capacity in the face of high numbers of patient referrals in routine care with limited staff to meet demand. Trial staff in both sites made empathetic references to being aware of mental health staff working within a context of immense pressure with a lack of resources and support. During the analysis by SA, it was constructed that the trial staff in EMPOWER felt it was inevitable that structural barriers that lead to mental health staff not having much spare time would inevitably be a barrier to trial recruitment.
Participant 1: I don’t think you can relate how busy they are. And much pressure they’re under. Some of the numbers we heard about in terms of new referrals into teams were quite staggering.
Participant 2: Forty. Forty referrals a week, yeah. And there doesn’t seem to be any sort of throughput to accommodate that additional pressure being moved around (UK)
High Mental Health Staff Turnover
Closely linked to a lack of staff time was high staff turnover, which appeared to be systemic across both trial sites. Meeting notes and focus group data from both the UK and Australia indicated that high clinical staff turnover became a challenge to recruitment. Practically, this led to issues such as new clinical staff not being aware of the study because they were not employed when staff teams were initially told about it. Clinical staff changing jobs or being off sick also appeared to be systemic issues within mental health services and was a macro level recruitment challenge. In this example below, a member of the EMPOWER team reflects on the impact of high staff turnover.
"What we’re seeing is the key workers [mental health staff] are very fluid, there’s loads of movement, there’s massive changes as to who your key worker is, there’s lots of staff turnover. ” (Participant, UK)
High Patient Turnover
A related sub theme (which was exclusive to Australia) was patient turnover because patients are discharged back to general practice following the end of an acute episode of psychosis, unlike in the UK where clinical support is generally more long term for people diagnosed with schizophrenia. This was a particular barrier to recruitment because if patients were no longer in the service, they simply could not be recruited. However, this issue intersected with high clinical staff turnover to result in a complex barrier to recruitment into the study because the high clinical staff turnover within mental health services blocked the ability of trial staff to build relationships with clinical staff to build trust in the team and the project.
"I think it’s also worth noting that in public mental health services it’s not only a high turnover of consumers but there’s also a pretty high turnover of staff in some places, so you would have some clinicians that hadn’t heard of it or you know were quite new around that time and that kind of translates to recruiting consumers as well in terms of the discharges and the change in people being part of the service (Participant, Australia)
Clinician Expectations
Mental health staff may act as a filter
Within the team meeting notes and articulated within focus groups, the research team were concerned that mental health staff sometimes acted as gatekeepers for some service users. This “gate keeping” behaviour appeared expressed when mental health staff assumed a potential participant would be unable to take part in the study, resulting in a filtering effect which biases what participants are invited to take part. Trial staff constructed that the concept of gatekeeping extended beyond participating in clinical research and was perhaps linked to mental health staff feeling protective over patients in their caseload. In the example below, a researcher reflects on how mental health staff appeared to very quickly decide on whether or not a service user could cope with the intervention.
We found that cases [mental health staff] were really quick to say I’ve got this person or this person specifically on my list who would be good and kind of having that conversation about the systematic approach that we wanted to have to recruitment was a bit of a hard sell because cases were saying well this person would never be able to use a phone and this person will sell it for drugs or will lose it immediately, too disorganized to use a mobile intervention (Participant, Australia)
Even when you approached them with eligible participants, they [staff] were maybe more likely to discount them straight away. Just say “no, they’re not suitable,” or “I don’t think they want to take part. (Participant UK)
Mental Health Staff Resistance to Research Participation
Within the UK and Australian sites, it was remarked that while mental health staff may have consented to take part within the study, this did not necessarily reflect their active involvement as participants within the study. Trial staff observed that mental health staff could engage in behaviours indicating resistance to the study.
Participant 1: because I don’t think that looking at consent figures for key workers reflects the buy into the study. …If someone asked you to sign one of these things [consent form] you’d sign it, and then you’d employ your tactics of trying to avoid having to doing anything about it.
Participant 2: You either cooperate or don’t cooperate.
Participant 1: …that’s a better way of putting it. [laughs] (UK)
Research staff working on EMPOWER theorised that mental health staff resistance to research participation emerged because mental health staff believed that they were expected to participate within clinical research as part of their role as mental health clinicians. There was some concern expressed that if mental health staff felt that their participation within the project was mandatory, this may have limited their motivation and commitment resulting in resistance to participation. In the following example, a member of the EMPOWER trial reflects on an encounter with a clinician who stated that they had to become involved because of expectations from management. This appeared linked with hierarchal relationships within mental health services. Therefore, clinical staff participating within research appeared to be a role expectation for clinical staff.
I remember one staff member talking about whether he agreed to be involved and he said “oh, do I really have a choice?” kind of saying “well, we’ve heard about it from, you know, management” and I got the sense he was communicating there was an expectation to get involved but that was just one thing I picked up about that kind of involvement. Yeah. (Participant, Australia)
Differences in Management Styles Within Clinical Teams
In both the UK and Australia there were discussions about differences in management style between the different mental health teams. In the first example, a trial team member explicitly stated that while participant numbers between sites may not have appeared too different, this obscured the challenges of having to adapt to different leadership styles across mental health teams. This was a viewed as a key determinant of recruitment success.
I think at the big picture level the rate of recruitment wasn’t particularly different and you know, [other named research assistants] might be able to say a bit more about the style of how it happens etc., there are certainly very different personality styles of managers so in terms of us managing the managers, we had to take into account that there are very different people who had a very different styles (Participant, Australia)
However, as pointed out in the UK site, it was not always the case that managers were those who were “pulling the strings” in terms of creating barriers to recruitment.
Leadership’s hugely important in this. And always underestimated how much influence it has in any field, but this one no less. That the messages and the values and the attitudes that are being shared by the person who’s pulling the strings is really, really important. And that person who’s pulling the strings isn’t necessarily always the person who is supposed to be pulling the strings (Participant, UK)
As indicated by the memo below, there was a real sense from the trial staff that differences in management styles were a particularly key recruitment barrier and that this should be given more emphasis within the analysis.
When I initially presented my analysis to trial staff, it was remarked that differences in management styles could be a key determinant of recruitment success and some trial staff members felt that this was underemphasised. (Researcher’s Reflective Memo)
While in the example below, two UK team members theorise how leadership within clinical teams may impact upon recruitment by discussing contrasts between a site where recruitment was easier and one where recruitment was perceived to be more challenging. From the perspective of trial staff (and aligning with ethnographic observations) differences in leadership style between managers were a very important factor in determining recruitment success because leadership shaped everyday dyadic interactions between clinical staff and trial staff during the recruitment process.
Participant 1:. The staff were able to take that sort of leadership role.
Participant 2: So. There’s quite a different style I think of leadership and management there that’s permissive.
Participant 3: Yeah.
Participant 4: Facilitating versus one that’s more “we’re doing this.” (UK)
Differences in Physical Environment
A further important recruitment challenge stemmed from the layout of the physical premises of mental health services themselves. While this may be unique to a particular centre, the impact upon recruitment was constructed by trial staff to be large. For example, two researchers recalled the impact of the physical layout of premises, which hindered their ability to develop relationships with staff and acted as a significant block to successful social interactions.
Participant 1: The physical environment’s really problematic there [named recruitment site] as well, because they’re all in small, separate offices, so it doesn’t really feel like a team. So individual and…
Participant 2: There’s nowhere to circulate and to talk to the nurses.
Participant 1: There’s nowhere to chat amongst yourself, just to build the rapport with nurses. It was like, everyone’s all huddled away in separate offices. (UK)
Trial Work Used to Facilitate Recruitment
Trial staff used several trial work strategies to facilitate recruitment in face of barriers including flexibility in approach to barriers; persistence and emotional labour (trial staff managing feelings and expressions in order to successfully recruit participants) in addition to building relationships (using pre-existing relationships with clinicians and utilising supportive research team relationships).
Flexibility in Approach to Barriers
Regardless of how barriers to recruitment were negotiated, something which stood out in both the minutes and the focus groups was the need for trial staff to be flexible in their approaches. Discussions around the benefits of flexible approach were common throughout both the Australian and UK focus groups. In the example below, a team member from Australia highlights that being flexible (and not rigid) in their approach to recruitment enabled staff to work through problems as they occurred.
I think that one of the real strengths in our research team has been how flexible and adaptive we’ve been when these challenges have come up, everyone involved in the process has been really thinking about ways to problem solve these things and coming up with suggestions (Participant, Australia)
One example trial staff provided which illustrates taking a flexible approach was in their discussions with clinical staff surrounding the trial protocol. Within a feasibility study, information about recruitment process is a key outcome. Therefore, when encountering potential staff ‘paternalism’ towards patients on their caseload, trial staff could emphasise that knowing how many people would refuse to take part was an important trial outcome. Explaining to trial staff that the protocol required that all relevant participants should have the opportunity to be approached, to discover numbers of patients who did not want to take part, was described as a it could circumnavigate the perceived filtering behaviours by clinical staff. In the example below, a principal investigator also describes how being flexible could enable trial staff to resist or negotiate staff paternalism, without it seeming like a direct challenge to clinical judgement.
…and our primary method of trying to get around that was to blame a third party to blame the protocol which says we needed to screen everyone and invite everyone rather than, you know directly, it feeling more like a direct challenge to the judgement of the key clinicians. (Participant, Australia)
The researcher noted in their reflective memo that flexibility appeared a key process that emerged from the very beginning of recruitment when trial staff were working to build relationships and engage with the staff. Trial staff did not appear to rigidly stick to one recruitment approach.
When looking through minutes from the start of the trial. I am struck by how apparent flexibility was from the early stages of recruitment. For example, working around the availability of clinical staff as much as was possible. Furthermore, it feels important to note that because clinical staff are so busy that being flexible appeared essential in moving recruitment forward. However, in later stages flexibility involved clinical trial staff (Researcher’s Reflective Memo)
Persistence
Within EMPOWER, trial work was characterised not only by flexibility but also by persistence. This could be seen in accounts of trial staff constantly trying to contact mental health staff. The practical work of chasing up mental health staff was readily apparent from analysis of meeting minutes and reflective accounts of the recruitment process recorded in both focus groups. Chasing up could involve telephone calls, email or visits in person to community mental health teams. This was often due to systematic issues such as a lack of staff time to support the intervention but could also be due to local factors such as mental health staff feeling pressurised into taking part by management and then resisting against participation. However, linked to staff describing their need to be persistent there was acknowledgement that chasing up mental health staff could be a time-consuming part of trial work.
It depended quite a lot on the key workers that were involved within teams. How open they were to the study, and how much they followed through on things they said they were going to do. So, a lot of the time was spent chasing up key workers who said they would do something, and then didn’t (Participant, UK).
Emotional Labour
While the need to be persistent in chasing up mental health staff and trying different recruitment strategies was apparent from both the minutes of meetings and focus groups, the focus groups foregrounded an important role for the emotional aspects of recruitment within a clinical trial. In the example below, it is clear that simply being persistent is not enough and that it is important for it not to be obvious that the research team experienced frustration. Indeed, the need to portray constant positivity in order to get the work done appeared to be considered key in successfully recruiting participants. Therefore, there appeared to be an important role for emotional labour within trial work.
Participant 1: Persistence. Always smiling. Always the utmost professionalism
Participant 6: Sometimes it’s fake. [shared laughter] (UK)
To the best of my knowledge, no trial staff used the term emotional labour to describe the maintaining professionalism during interactions with mental health staff, carers and patients. However, when reflecting on my observations of the research process, emotional labour appeared a highly relevant interactional framework for understanding the actual work underpinning trial staff describing the competency of staying polite and professional even when faced with potentially stressful challenges. Emotional labour seemed especially pertinent because trial staff are trying to invoke positive feelings within clinical research staff to build trust in both the project and the research team themselves. (Researcher’s Reflective Memo)
Building Relationships
Trial work appeared to be sustained and facilitated by relationship building. When trial staff described the work that they performed throughout the recruitment process, at all stages the work appeared to be underpinned by trial staffs’ ability to successfully build and utilise relationships. In the absence of the ability to tap into existing relationships, trial staff had to be able to quickly build working relationships with clinical staff to facilitate the recruitment process. Reflecting on the overall emergent process, trial staff centred the importance of building relationships with clinical staff in both the UK and Australia. One key change that came from this was trial staff becoming trusted to make direct approaches to patients instead of always having to go through mental health staff.
I think the reason that it became more possible was um that the services got used to the research team and got confident in the research team, or at least management did, so I think there’s something about us building the relationship that enabled us to move into a different way of doing it (Participant Australia)
From appraising the minutes of the team meetings, it is clear that trial staff initially had to go almost entirely through mental health staff. However, if a good relationship was built—this was perceived as helpful for recruitment because the staff were generally more engaged with the team.
Recruitment did not start at the four randomised mental health teams at exactly the same time. From analysing the minutes of meetings for the period October 26th to December 21st (all 2017), it appeared that initially members of the research team met with key clinicians to screen for eligible participants together and then this built up to the team making direct approaches for one of the community mental health teams. This process continued into early 2018. Moreover, from observations it was apparent that an enthusiastic key clinician or manager with whom the team had a good relationship appeared to be helpful in terms of recruitment. (Researcher’s Reflective Memo)
Within two months, trial work moved on to the establishment of relationships between mental health staff and the research team. In this stage, the EMPOWER staff became trusted to make direct approaches. Linked to the process of building relationships over time with mental health staff, in both Glasgow and Melbourne, a clinical team member (Research Nurse and Peer Support Worker, respectively) became involved in trial recruitment. Both teams reflected upon this positively because both of these clinical team members brought their pre-existing relationships with clinical staff. While the earlier stages of recruitment may have seemed slow, it appears productive in terms of carrying out trial work that built relationships and trust with clinical staff, ultimately moving trial recruitment forward. (Researcher’s Reflective Memo)
However, the barriers to recruitment could nonetheless block trial staff from using relationship building strategies. For example, the issues discussed by staff covered under the Differences in Physical Environment theme appeared to be a particular barrier to the ability of the trial staff to develop positive working relationships with trial staff.
From my observations of trial recruitment within EMPOWER it really did appear that idiosyncratic issues (of which physical layout was one) could nonetheless seriously constrain the recruitment process. The recruitment processes appeared to be constrained because it blocked the ability of trial staff to utilise their dynamic relationship building strategies (Researcher’s Reflective Memo)
Utilising Pre-Existing Relationships
While building relationships underpinned all aspects of trial work, pre-existing relationships were described as helpful in establishing clinician trust. The “trial work” here is the insight and ability of the trial staff to utilise those pre-existing relationships in the service of recruitment. In this example, a research assistant stated that clinical staff felt more comfortable communicating negative feelings about the recruitment process to the peer support worker (part of the EMPOWER trial team) because of pre-existing ease and trust that comes with already knowing someone. The research team were then able to use this information and adapt the approach taken to recruitment to be less aversive for clinical staff.
I think the real turning point where [peer support worker who participated in recruitment process] was speaking to somebody perhaps because she has that more casual kind of pre-existing relationship with some of these people where they were explicitly saying “I’m a bit sick of this EMPOWER stuff” and that’s when you know, that sent out the message we need to pump the brakes hard in terms of how much we are asking clinicians to do here. (Participant Australia).
Relationship building—internal within the research team.
Relationships appeared to serve important internal functions within the EMPOWER team. Across both the UK and Australia, trial staff made reference to the importance of having a team who understood the challenges associated with clinical trial recruitment. Furthermore, the importance of having space to be open about difficulties encountered so that discussions were focused around how best to move forward was described.
Because I think at times it is quite demotivating. And particularly if you’ve got that third [unanswered] phone call and think “please just answer the phone.” I think we [trial recruitment staff] do try and support each other through those times (Participant, UK)
From the meeting minutes, being part of the UK meetings while recruitment was on-going and appraising themes constructed during the focus groups, it seemed as though having a space within the trial team to discuss and share frustrations that were inevitable from negotiating the various recruitment barriers. From my observations of actual meetings and continued within the focus groups, there appeared to be lots of in-jokes within the teams about the recruitment process including challenging aspects. For trial staff, this appeared to provide camaraderie and support (Researcher’s Reflective Memo)
To summarise, relationship building internally within the team appeared to be just as important in facilitating the recruitment process as building external relationships with mental health staff. Trial staff were there for each other throughout recruitment challenges and provided a supportive space for each other to discuss problems.