Relationship between the patient and professional
Relationships were identified as an important influence when considering whether to participate in the trial. Many chose to participate because of their relationship with their usual clinician. Being approached by a familiar clinician appeared to validate the authenticity of the trial.
‘It came through erm when I was at the erm, IPF meeting and my consultant was there actually that day giving a talk as well, so I figured that, you know, it was bona fide, cause you, lets face it, you don’t know.’ 1010, Female with ILD >65 years old
The ability of their usual clinician to listen and communicate effectively further instilled trust, and made patients more likely to participate.
‘My doctor, yes, he said ‘well try it, anything’s worth a try’. Its our GP, yeah. Yeah, we’ve known him for a while, yeah. And he’s a doctor that listens to you… he’s very good like’ 1022, Male with COPD >65 years old
The initial encounter and subsequent relationship with the research team was also important. Clear communication of trial related material established confidence in the research team.
‘The interviewer, interviewers (research team) were very pleasant, very helpful, they explained everything to me and I agreed to it’ 1001, Male with COPD >65 years old
One participant worried about the expectation that might be placed on them, and felt reassured when the initial assessment was tailored and focused to their individual needs.
‘I thought well, you know, I hope they’re not going to push me too much, you know, cause I’ll just have to refuse to do it. But everything was fine, you know, spot on, you know. They understood my needs’ 1014, Male with COPD <65 years old
Context was important when deciding whether to participate and was considered in relation to both trial processes and the intervention. The opportunity to be visited at home instead of going into hospital was a positive influence and made people more likely to participate in the trial.
‘I didn’t have to go to the hospital… you do home visits, and that, that made my mind up even more to do it. Because of the struggling to walk and everything else, so I was more than happy’ 1003, Male with COPD >65 years old
Although we only interviewed people who had participated in the trial, the interviews did provide some detail of influences relating to the intervention which would have made people less likely to participate. Concerns about potential adverse effects were a deterrent and one of the participants who withdrew during the trial period after experiencing adverse effects felt that more information could have been provided about the trial medication:
‘It wasn’t a great deal of information about the actual drug, to be honest’ 1016, Male with heart failure >65 years old
Whilst some participants expressed concerns about taking an antidepressant medication, this was mostly offset by trust in the clinicians and researchers, and a belief that they wouldn’t be given anything which could cause harm.
‘That was my thought when they first said antidepressant ‘oh, do I want to be taking something like that?’ but at the end of the day, they’re not going to do anything that’s going to put you at any risk’ 1020, Male with COPD <65 years old
Some participants explained that it was important that the trial design enabled them to continue to take disease specific medications.
‘I’d contacted erm, I rang up the hospital and asked, and they said, ‘yeah, you’ll be ok, ones for your brain and ones for your lungs’’ 1010, Female with ILD >65 years old
Potential benefit to self and others
The possibility of potential benefit was a large contributing factor when deciding whether to participate in the trial. Most commonly participants described hoping for an improvement in symptoms, above all their breathing. One women living with COPD stated.
‘I was prepared to try anything that would help with me breathing’ 1015, Female with COPD >65 years old
Many viewed the trial as an opportunity to have extra input from clinical services. This included additional assessments prior to enrolment, as well as regular monitoring throughout the trial.
‘I had a full, er, a medical before I started on the course, which was good, it eased my mind’ 1015, Female with COPD >65 years old
‘They just told us, as I say that we would be, regularly monitored’, 1010, Female with ILD >65 years old
One participant felt that he had benefited from seeing a specialist as part of the trial.
‘It opens doors at the hospitals for you, like I’ve got to see a specialist through it’ 1022, Male with COPD >65 years old
For many, living with chronic breathlessness can be an isolating experience, and therefore the social aspect of participating in the trial was perceived as a potential benefit, with the trial providing an opportunity to meet other people who were in a similar position.
‘I was gonna gain and that I would be meeting a few more people’ 1009, Male with COPD >65 years old
Participants appeared to understand the concept of randomisation and were mostly accepting of the fact that they may not receive the active medication.
‘Erm, well somebody’s got to get it I think, you know, it, I, I don’t really, I just sort of tried to take it in my stride, and whi- whichever I get, I get, cause there’s not a lot you can do about it’ 1001, Male with ILD >65 years old
Some participants did express concerns about receiving the placebo medication and therefore not experiencing a potential benefit.
‘Only if it wasn’t the drug… then it might not be a chance of it working… which you in my case seems it wasn’t the drug or it wasn’t working… I lost hope, lost hope in it’ 1008, Male with ILD <65 years old
Altruism was also commonly described, individuals wanted to participate to help others, regardless of whether they would experience a direct benefit. One man with COPD explained that he did not expect the trial to help him, but hoped it might benefit others in the future.
‘It won’t do me any good but it might help other people in the future, you know. So, my expectations are in the ways that it’ll help other people in the future, you know, by me taking a part in these trials’ 1014, Male with COPD <65 years old
Participants also talked about their individual experience of receiving healthcare, often over a number of years, and many felt that the trial was an opportunity to be involved, and give something back to the health service.
‘I have had some wonderful service from the NHS (National Health Service), and I thought well this is a chance to pay something back by taking part’ 1004, Male with COPD >65 years old
Some people recognised the importance of clinical trials in the context of research, and wanted to participate to advance science, and help to develop new treatments.
‘People need to know about these things… if it is going to help then I’ll take part in these trials. To, you know, help, help science’ 1005, Male with ILD >65 years old
Relationship between the patient and professional
The importance of the relationship between participants and the research team was identified across all interviews, and was substantial when considering the reasons why participants remained in the trial. Attempts by the research team to minimise burden and ensure a calm environment were recognised by participants.
‘I found the people extremely helpful, nothing was too much trouble. Everything was explained in meticulous detail really, it was, it was so easy, everything was done for you, the drugs were all measured out you had the right number for the right days. All I had to do was wake up and pop the pill, you know. The people were lovely, it was a very very rewarding experience in a lot of ways’ 1020, Male with COPD <65 years old
‘Like Jen (research nurse) said, if there’s any problems and you can’t make it, just give us a ring or anything like that, there’s no, you must arrive or that sort of thing. And it’s a relaxing place, when you go there, there’s no hustle and bustle or owt.’ 1013, Male with COPD >65 years old
The personal attributes of the researcher were also central to remaining in the trial. Participants described the importance of effective communication, and not feeling rushed during trial visits.
‘When you came here people took the time and they listen to you. They actually ask you a question, but they listen to you, they didn’t jump in and try to answer for you, you know, which I thought was good. As I say, everything was so relaxed, so calm and, you know, if I’d come here and I’d been under pressure I’d have says nah I’m not going there again’ 1014, Male with COPD <65 years old
‘You come to this clinical trials unit here and the girls (research nurses) are absolutely brilliant, and that does make a difference, you know that you’re going to walk in there and come what may- You feel part of the family actually, now -you know, chatting, and they explain things so well don’t they, and they’re so patient and you know, they must get some cantankerous people in here and yet their attitude never changes in there does it?’ 1012, Male with ILD >65 years old
Continuity was also important and enabled participants to build up a relationship with the research team. One participant explained that while they didn’t always see the same member of the research team, someone that they had met before always made an effort to come and say hello when they first arrived at the trials unit.
‘I’d go in and sit down, they’d maybe make me a cup of tea if I was waiting and whatever, then they’d come through. It wasn’t always the same person, but Kim (research nurse) would pop in and say hello and she’d say so-and-so’s seeing you today’. 1020, Male with COPD <65 years old
In contrast not being given clear trial related information and feeling rushed by members of the research team was reported by one participant who chose to withdraw from the trial. The participant stated that they had chosen to withdraw due to adverse effects of the trial medication, however it is possible that these two sub-themes which sit within the overarching theme of relationships may have contributed to, or influenced this decision.
‘It wasn’t a great deal of information… it was a bit rushed wasn’t it, yeah’ 1016, Male with HF >65 years old
The context of trial processes and the intervention was important when considering the reasons why participants remained in the trial. The research team providing clear information appeared to ensure that the trial ran smoothly, and the offer of home visits made it easier to participate.
Being at home was perfect, you know, they were always on time, and prompt so yes, no problem whatsoever there. Oh the home visits are quite good you know. Saved me a lot of bother not going to the hospital’ 1002, Male with COPD >65 years old
Participants found the questionnaires straight forward to complete and the research team were always there to provide help if required.
‘If there were any problems then they would run me through the questions’. 1020, Male with COPD <65 years old
The intervention was simple and well tolerated and participants found the chart provided a useful reminder.
‘It was tablets and I took them every day as I was asked to, um we made a note of them in a chart to make sure I had taken them, it was no problem at all’ 1001, Male with ILD >65 years old
Trial duration was also important with a shorter duration felt to be more manageable.
‘I thought that as it was also only over a 28-day period I thought yeah, I’d, I’d be quite happy to try.’ 1010, Female with ILD >65 years old
Adverse effects of the intervention were an important influence for participants discontinuing the trial and were reported by both participants who were interviewed after withdrawing from the trial.
I just sat up in bed looking at the tablets and thinking, should I chance it tonight or not, because I knew how I might feel a bit groggy the next day, so it put you off taking the tablet’ 1019, Female with ILD >65 years old
Potential benefit to self and others
Perceived benefits motivated participants to remain in the trial. An improvement in symptoms was described by a number of individuals.
‘Everything was so much better. I would sleep better, so if I sleep better that means by breathing is better when I wake up in the morning, which it never was before… they have definitely really helped. Everything has just changed for the better, you know, you know I am so glad that I have done it.’ 1003, Male with COPD >65 years old
Participants also perceived the regular monitoring they received during the trial to be beneficial. They felt taken care of and were therefore more likely to remain in the trial.
‘I think the way you’ve conducted the trail has been very very good, the follow up has been very good. I was seen at weekly intervals to see how things were progressing, and if there were any problems, so I felt I was being taken care of in terms of the trial’ 1017, Male with ILD >65 years old
The social aspect was an additional benefit for many participants and provided an interruption to an otherwise sometimes isolating existence. This was described by participants visited at home but also those who were reviewed in the trials unit.
‘I quite enjoyed the experience of having somebody to come in and talk to me’ 1001, Male with ILD >65 years old, visited at home
‘They could’ve come to my home, but I prefer to come here cause it gets me out the house for an hour or two… its nice just to come somewhere and as I say, meet different people, see different people, which is half the battle when you, you know’ 1014, Male with COPD <65 years old, attended the trials unit
It was important that participants felt actively involved and as though they were contributing to the trial. Knowing that the trial may benefit patients in the future, as well as providing an opportunity for individuals to give back were motivating factors for completing the trial. Several participants described how they found the trial process rewarding on an individual level.
‘I just felt as though I was doing some good. It was personally rewarding for me, because I felt as though I was contributing, you know’ 1020, Male with COPD <65 years old
The three important considerations which appear to improve recruitment and retention in clinical trials closely relate to the core elements of PCC identified by Kitson (21). We therefore propose a model of PCC in clinical trials which incorporates three components: prioritisation of the relationship between the patient and the professional; ensuring a person centred context; and enabling the patient to participate and be involved (Figure 1). We believe that this approach may improve recruitment and retention by ensuring that clinical trials are person centred and focused around the needs of the individual.
Figure 1: Person centred care in clinical trials