In-depth interviews were used to collect data about staff experiences of study closeout, as these afforded the flexibility needed for participants to raise and discuss issues that they perceived as being salient, including those unforeseen at the study’s outset.142,174The use of one-to-one interviews also afforded privacy, allowing
participants to share their views about the processes and procedures for closeout at their study centre. The study was informed by the principles of Grounded Theory140and entailed simultaneous data collection;
this allowed the areas explored in the later interviews to be revised in light of emerging findings.
Recruitment and sample
Working closely with the CTRU to identify relevant individuals, we targeted all staff members (physicians, diabetes specialist nurses and dietitians) in the REPOSE centres, who were thought to have been actively involved in closeout appointments. Staff were recruited from seven of the eight participating centres. The eighth centre was not included because it was a reserve centre that was added at the end of the trial to deliver two courses only, and this centre had only one patient using a pump at the end of the trial.
Staff were recruited via written (e-mail) invitations accompanied by information sheets and opt-in forms. When staff had opted in, NH contacted them to arrange an interview.
Data collection and analysis
The University of Edinburgh’s Centre for Population Health Sciences, Ethics Review Group granted ethics approval for this study in June 2015. The interviews took place between June and August 2015.
Participants were offered the choice of a telephone or face-to-face interview at a time/place most convenient to them; only six (29%) staff members requested a face-to-face interview.
Interviews were informed by a topic guide that was developed in light of literature reviews and findings from qualitative research conducted earlier in the trial,147,155and were revised in light of emergent findings from
the early interviews. The final version of the topic guide is appended to this final report (seeAppendix 16). Interviews lasted for≈60–90 minutes. The key areas in the topic guide were covered and explored in depth in all interviews. Interviews were digitally recorded (with consent) and transcribed in full for in-depth analysis. By the time recruitment and interviewing had stopped, data saturation had been achieved, that is, no new findings or themes were identified in new data collected.
The interviews were analysed thematically by NH and JL using the method of constant comparison.148
Individual interviews were read through repeatedly to look at differences and similarities in individuals’ perspectives and experiences before being cross-compared to identify common issues and experiences across and within study centres. NH and JL wrote separate reports before meeting (both during and after data collection) to discuss and reach agreement on key themes, identify emerging findings requiring more detailed exploration and develop a coding frame. The qualitative analysis software package NVivo10 (QSR International, Warrington, UK) was used to facilitate data coding and retrieval. Coded data sets were subjected to further, in-depth analysis to identify subthemes and illustrative quotations.
The findings presented below are structured under our original research questions. To safeguard participants’ confidentiality, pseudonyms for individuals, Dr X (diabetes specialist) or EDX (DAFNE educator–diabetes specialist nurse/dietitian), and centres (A–G) are used throughout this report, and all identifying information has been removed or deliberately altered.
Findings
Participants
Twenty-four staff members were invited to participate. In one case a staff member said that they had no direct experience of closeout/end-of-trial consultations. Two others opted in, but an interview could not be arranged at a convenient time, hence 21 (87.5%) staff members were interviewed. Full details of the final sample are provided inAppendix 17.
As can be seen fromAppendix 17, we achieved good representation of different types of staff: clinical diabetes specialists, diabetes specialist nurses and dietitians. Between two and five (mode three) members of staff were interviewed at each centre. With the exception of centre A, at least one DAFNE educator and one diabetes specialist was interviewed from each centre.
Staff experience of delivering DAFNE varied from 5 to 17 years (mean 10 years). There was also variability with regard to individuals’experience of pump therapy, ranging from 2 to 37 years (mean 10 years). It should be noted that the majority of staff interviewed at centres D and E had relatively little experience of pump therapy prior to delivering REPOSE. Although many staff had previous experiences of working on clinical trials, few had been involved with studies that had required new technologies to be withdrawn at the end of the trial. The main exceptions were those staff members (n=5) who belonged to the three study centres that had been involved in the delivery of a DAFNE pump pilot study. This 12-month study27–
In order to understand staff members’experiences of closing out REPOSE, it is necessary to provide an account of what happened at the end of the trial in the various centres. Thus, prior to answering the research questions, we will describe the variations in closeout practices that staff described in the different centres.
Background: closeout practices in REPOSE centres
As noted above, the CTRU issued a SOP for closeout (seeAppendix 15), which outlined what was to happen up to the point at which all trial procedures were completed (i.e. final blood samples were taken, QoL measures collected and data from the pump downloaded). What happened to trial participants afterwards–whether or not they remained on MDI/pump, whether or not they had pump therapy
withdrawn or initiated–was a clinical decision, taken by staff at the individual centres. In other words, the decision to leave patients on, start or terminate pump therapy was not a trial decision. However, many of the staff involved in delivering REPOSE experienced these post-trial treatment decisions and, more specifically, patients’reactions to them, as part of their trial experience. Thus, for the purpose of this chapter, we will talk about post-trial treatment decisions as part of the closeout process because this is how the staff perceived and interpreted them.
To ensure that resources (i.e. pumps) were allocated appropriately and fairly at the end of the trial, most centres put site-specific procedures in place for closeout (i.e. what would occur after the final downloads had been logged). Some centres adopted very formalised operational procedures for decision-making about post-trial treatment. In these centres, decisions about individual participants were made at a multidisciplinary team (MDT) meeting, involving all of the research team and other staff members, and which took place a couple of weeks before the closeout of each of the groups. The MDTs’decisions were governed by strict NICE/Scottish Intercollegiate Guidelines Network (SIGN) criteria (seeResearch question 2) and (normally) documented. Each patient then attended a post-trial consultation with a clinician/educator after the final data collection session to discuss his/her treatment plan.
Other centres took a less formal approach to closing out their patients. Dr H described what happened in one such centre (centre B):
I guess it wasn’t a formal MDT. But yeah it was just a chat with the educators and myself about each individual patient as they were coming up for the end of the study, about who/what the best way forward was for them.
In some of these centres, the whole research team met in advance of the post-trial appointments to discuss what might happen in individual cases; in others, the educators briefly spoke to the clinician after the patient had provided their final download and before they went in for their post-trial consultation. In these centres, although some, or all, trial team members had some input into post-trial treatment decisions, it was individual clinicians who made the final decision during the post-trial consultation, often taking the patient’s views into account:
We started a fairly neutral conversation about how it been and what would they want to do if the option were that they could keep it. And then if they said well you know, they’d really like to stay on pump therapy then I said‘OK, well you know, let’s have a look at how you’ve got on with it’and obviously I’d got a feel for that already. So before they came in [educator] and I sat down and looked through and looked at how they’d got on, and what had happened to hypoglycaemia frequency, what had happened to HbA1c, and then obviously they came through and told us how they felt in
terms of, the impact on quality of life and things.
Dr G In all of the centres, the clinical appointment to discuss post-trial treatment occurred after the final
appointment to collect trial data. In some cases, patients were seen on the same day on which they came in for their final trial appointment; in others, this clinical appointment occurred a couple of weeks later.
Research question 1
l What are health professionals’experiences of closing out the REPOSE Trial? What (if any) practical/ ethical/other issues arose for staff and how did they attempt to address these?
What are health professionals’ experiences of closing out the REPOSE Trial?
Staff who had been involved in follow-up appointments during the trial, primarily the educators, said that they had become increasingly aware that withdrawal of pump therapy at closeout/the end of the trial would be difficult. This was a result of their observations (see ED7 below) that patients were becoming increasingly emotionally attached to their pumps as the trial progressed, an issue which became particularly apparent from the 12-month follow-up appointment onwards.
. . . at the kind of the routine REPOSE follow-ups when we asked them how they were feeling about the pump, they all reported that they loved the pump, that they felt it was making their life so much easier, and that they couldn’t imagine going back to having to inject multiple times a day . . . So they were all very vocal that they really wanted to stay on their pump. And that they would be prepared to fight for it, if needs be.
ED7 For this reason, some staff reported worries and concerns about how patients might react to the
withdrawal of the pump at the end of the trial:‘I knew it was going to be difficult and I wasn’t looking forward to it’(ED11).
Dealing with stressful situations
The ways staff experienced these post-trial consultations varied, and was related to whether or not patients were able to remain on their preferred therapy and, as will be described later [seeWhat (if any) practical/ethical/other issues arose for staff and how did they attempt to address these?], whether or not staff had put pre-emptive measures in place to manage and prevent problems arising from the withdrawal of pump therapy. In some cases, when patients who wanted to remain on a pump were told they would have to revert to MDI, staff members, including Dr C, described situations that had been stressful and difficult to manage because patients had become upset and/or angry:
I had trouble in the course, because one lady when she came to the end of her trial, her HbA1cwas
appalling. I mean it was appalling. There was no way you could justify leaving her on pump, because she was getting no benefit from it biomedically. What she needed was a complete change in how she managed her life. And she was very upset to have the pump removed. But what was fascinating was she did not say that at the closeout interview . . . . Next thing I know she’s written streams of letters of complaints to all and everybody, because we removed the pump from her, and refused to give her any supplies after 3 months.
Dr C Later in the interview, Dr C reflected on how this and other similar experiences had‘. . . kind of tainted the whole study for me, because it was really quite difficult for a little while. It was very uncomfortable’. Dr B reported a similarly stressful encounter with a patient:
The one locally that really didn’t go well, was a gentleman whose control had got worse on the pump. And I was explaining that in fact on balance it was actually more dangerous for him to remain on pump. And he was the one that walked out. He didn’t shout or give me any indication. He just stood up and said‘OK’and walked out.
Dr B Like Dr C, Dr B had been taken aback by this experience: they had been ill prepared for it, primarily because, like the other clinicians in the study, they had been less involved in the trial follow-up visits, which had been mainly carried out by educators.
Smooth transitions
However, the withdrawal of pump therapy was not always experienced as generating such negative reactions; indeed, a small group of patients, across the centres, were described as having been‘happy’to revert to MDI, with some requesting this transition at the end of the trial. Moreover, in another centre (centre A) at which pump therapy had been withdrawn from the majority of patients, staff said that closeout had been relatively straightforward and non-confrontational. As will be described further later [seeWhat (if any) practical/ethical/other issues arose for staff and how did they attempt to address these?], this appeared to be due to staff having put procedures in place to pre-empt, prevent and manage
disappointment among those patients.
In approximately half of the centres, patients received the treatment that they wanted at the end of the trial, and closeout, as a result, was experienced as raising few issues for staff. This was particularly the case in Scottish centres where, in 2012, the Scottish Government had made funding available for pump
therapy, with a target of≈5% of patients with T1DM to be using pump therapy between 2013 and 2015. As Dr E reflected, because of the Scottish Government’s largesse, closeout was very straightforward in that centre because the majority of patients were able to remain on pump therapy if they wished to do so:
Our closeout has probably been less complex than most places. And that’s because of this impetus to increase the number of people with pumps . . . Happily for us, because the timing was just perfect, so that the end of the trial was within this expansion up, we were actually able to fairly straightforwardly continue with pumps on a routine NHS way for all of the patients who wished to.
Dr E ED3, from another resource-rich centre, similarly said‘I think it [closeout] went well. There was nothing certainly from our side in [site D]. I don’t think there were any issues for us’.
Staff at the Scottish centres did comment that, had government funding not been put in place during the trial, closeout would have been more challenging and problematic:
Well I guess we would have been in the same situation as other centres where there was no funding stream to continue patients. And we would have had to say:‘sorry. We don’t have any money for you to continue on this’. And I think it would be very difficult. I mean obviously I would imagine in other places it’s caused a bit of damage to the doctor or health-care professional relationship . . . I guess people having invested a lot of time in it over the course of the study you’d feel a bit let down if somebody’s told that there’s no money. Sorry, give it back.
Dr H Although staff at such centres did not generally have to manage patients’reactions to the withdrawal of the pump, they did have other issues with which to contend. First, as Dr E noted, they had problems providing timely training for all MDI patients who were offered, and accepted, pump therapy at the end of the trial:‘Most of our control patients were really quite keen to go on pumps, afterwards. And the, you know, there’s a degree of work just dealing with that’. Second, even though patients usually received the therapy they wanted after closeout, the staff said they still had to reassure and‘calm down’patients when they came in for their final downloads because they were anxious about losing their pumps:
On the day of their final visit I think they were all extremely heightened, they were very worried I think most of the patients who came in. We kind of had to almost calm folk down a little bit. We had quite a few who were walking in the door at that final visit very, very scared because they knew it was the end of the trial and they didn’t know what was going to happen now.
ED6 As ED6 commented, dealing with patients’anxiety throughout the trial was particularly difficult in their centre, as although staff realised that most people would have their pump therapy funded after the trial, they still had to follow the trial SOP, which required staff to be more circumspect when patients asked about post-trial treatment during follow-up visits.
Differences of opinion within multidisciplinary teams
Finally, with regard to their closeout experiences, some staff indicated a lack of consensus within some research teams regarding the decision to keep particular individuals on pump therapy at the end of the trial:
And I think there was a difference in how some of the team viewed it as well, in that some seemed to say: well, it’s a trial for 2 years. And then they come off the pump and we see how they do. And then we may put them back on the pump. Whereas others are saying: well no there’s been significant improvement, So we’ll keep them on the pump. So I had kind of extremes.
ED12
I think others (in our site) were much more, I . . . I think that they thought that they were going to stick to the letter of the law and they’d take pumps away and that would be tricky . . . but then that’s their individual practice it’s not for me to tell colleagues particularly consultants how they should practice, and the practice is very different it’s such a personal thing.