Skip to main content

Table 4 Themes describing the overarching theme of communication of retention information at consent and associated belief statements; REC-00 = recruitment staff participant ID

From: What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives

Theme

Belief statements (and their domains) comprising theme

Illustrative quotes for belief statement

Recruiter reflections on their practices and overall trial retention

I consider retention to be… (Knowledge)

“So, retention on to a study would be to achieve all of the follow-up that was included as part of the study, and the reason for that is because of the outcomes and answering the question. Yeah, follow-up, so retention is completing the follow-up and completing the study.” – REC-04, senior research nurse

I know what follow-up involves in my study and how I talk about it with participants (Knowledge)

“It’s really just ensuring that the study that you’re recruiting them to, that you’ve got a good understanding of it, so that you can explain to them… you know, “This is your level of involvement that we need” or, “There’s not that much involvement. We do this at the screening visit, and we collect your bloods, and we collect some data, and that’s it. We don’t need anything else from you.”

There might be some follow-up questionnaires maybe from the study centre, but in terms of us, there’s not really much else involvement. Again, it always just comes back to the same point, I think really, just about being informed.” – REC-06, research nurse

I am aware of retention in my study and what we do to ameliorate issues (Knowledge)

It [dropouts] happens, in honesty I’ve not picked this up as a problem, and in a way the main counselling I do with them is at the time of consent really. After that, because they get sent questionnaires directly by the trial office, and I suppose the trial office will let us know if they are struggling to get a hold of a patient, but we’ve not had that experience to be honest, either because the trial office has not told me, or because they have been successful in chasing up my patients. I mean I see the patients and I chat to them, and I say, ‘have they sent you anything’ and they say ‘yes, they sent me a questionnaire and I filled it in’, but we have not had a problem that way as far as I know.” – REC-12, consultant

I am aware of research about retention (Knowledge)

“I guess we’ve got some maybe some slightly innovative ways that have been developed through this unit to try and aid retention. We do send things out like a reminder card prior to a questionnaire, so that patients are aware that that’s coming out soon. And I’m sure this us all evidence-based to ensure retention.” – REC-14, research nurse

The training I received did not typically cover retention (Skills)

“I’d say most of the training that I’ve had has been quite practical, so I’ve done an online course of approaching patients which is called Granule, but that’s more about the randomisation, explanation about how you kind of approach… keeping equipoise within both of the treatments. It didn’t really go much into follow-ups.” – REC-02, research physiotherapist

I am confident in my ability to discuss follow-up during my recruitment discussions (Beliefs about capabilities)

“Yes, I wouldn’t sign up to the trial if I wasn’t comfortable discussing it [follow-up].” – REC-12, consultant

The importance of trying to contribute to retention

It is necessary that I discuss follow-up (Intentions)

“R—So when you go into those discussions do you always intend to discuss retention with the participants then?

P—Yeah, absolutely, yeah

R—Does that vary or change over time or is it about the same?

P—No, it’s part of the, in my opinion it’s part of the consent process. If you’re consenting a patient on to a research trial then you have to discuss retention.” – REC-15, research nurse

I think consent is only valid if participants have received an adequate amount of information about follow-up (Beliefs about consequences)

“It’s [talking to potential participants about follow-up] part of valid informed consent, you know? You’re not receiving consent just to say, “Yes, you can do this operation,” or, “Yes, you can give me this medication.” The whole study is what you need to take valid informed consent for, and so ensuring the participant is saying yes to all the parts of the study, it’s as important to have their consent to keep seeing them for a year, as it is for them to have the original intervention.” – REC-13, research nurse

I would hope that my conversations about follow-up have an effect on retention, but I am not sure they do (Optimism)

“R- Do you feel that discussing completing study follow-up with potential participants during recruitment makes a difference to retention overall?

P– I’m not actually sure. No, I’m not sure about that one actually. I don’t know. I’m trying to think of examples where I maybe have in the past, but I don’t know whether that’s been a specific thing that’s give patients on a trial or not.” – REC-06, research nurse

Knowing that my work has contributed to retention and, ultimately, to a successful trial motivates me (Reinforcement)

“I think I mentioned earlier, it’s always in the back of my mind, and I try to bring it into my approach that we need to… that there is this follow-up and if they agree to take part in a study, we’ll need to see them again at these different time points. If they agree to participate and then if they agree to the follow-ups as well, that’s definitely an incentive because that’s what we wanted, and that just looks really good in the study that we’ve had someone who’s been engaged throughout the process at all the different timepoints.” – REC-07, research fellow

Being responsive to the individual guides the conversation

I think seeing participants as individuals can drive your approach to be tailored to them (Social influences)

“If something works well then carry on using that to get patients recruited and be on the study. Also, the other side, if I feel that I’ve done something that hasn’t worked quite as well that time because the patient didn’t receive it in the way that it was maybe meant or whatever, I think that side of it is all good to learn from. No patient is the same, so each time you go in you might have a way of doing things, and I think doing lots of different studies is good in one way because you’re not just doing one study where you’re saying the same thing all the time, you’re jumping from study to study and seeing different patients for different things. I think it keeps you on your toes a little bit more because you’re not just getting into a way of discussing a study with a patient, you know, it’s not the same thing every time. It’s good to see the patient as an individual and talk through things and let it be quite fluid.” – REC-09, senior research nurse

My role as a recruiter is to be transparent with participants about what study participation actually involves (Social professional role and identity)

“R—So how does talking to potential participants about follow up and completing the study how does that fit within your role as a recruiter?

P – It’s completely in my role as a recruiter because you don’t want to recruit a patient to a trial and then they don’t follow… then they don’t [complete] the follow up. So it’s hoping when you’re recruiting a patient that the follow up and what’s expected of them when you’re recruiting them, the patient needs to know what’s expected of them. So that’s definitely a conversation, retention and follow up.” – REC-15, research nurse

You need to be able to set and manage expectations about follow-up with participants (Skills)

“In terms of the follow up it’s explained very quickly on the video. But we do tell them that the questionnaire that they’re completing at that time it’s no more arduous – the follow up questionnaires are very similar to the questionnaire they’re dealing with at the baseline. So they have this idea of what’s expected of them because I think managing expectations is really key in this.” – REC-03, research nurse

I try to highlight to participants what their commitment to the trial actually means for them (Goals)

“That’s important to highlight to participants, to say that this is a long, ongoing trial, but to make it clear what the actual involvement is going to be, so is it just going to be a questionnaire through the post at three, six, twelve, and then twelve-monthly for five years, for example. Are participants going to have to physically attend a hospital or a trial site? How much time is involved in each of these follow-ups, and generally, especially for PROM studies where there are questionnaires being sent out, it’s not a very arduous workload. But, for example, a CTIMP study might involve physically coming into the hospital every six months for five years.” – REC-13, research nurse

I present enough information about follow-up to inform participants, but not so much that I overburden (Skills)

“No, I guess sometimes if it’s an intense follow-up, I guess that’s perhaps the time that it can perhaps be slightly more challenging in the way that you present it. If there’s a lot of follow-up required from it, the patient may not want to be involved for that very reason but you need to make sure that they’re aware of everything, but equally not scare them off because of the quantity.” – REC-04, senior research nurse

I think it can be overwhelming to participants if we provide them too much information about follow-up (Beliefs about consequences)

“I think there is a danger of getting swamped down in follow ups. And I think a lot of research and recruitment is how you present it to the patient. And I think there is a drawback in getting swamped down. […] I think you can overwhelm a patient with information. And if you’ve got somebody who’s in pain and who just wants their [CONDITION FIXED] but wants to do the study and you’ve gone through everything. You still need to mention follow ups, but I think it’s more a case of, you can say, by relaying exactly – you could go too much into detail. And I think that can be quite overwhelming. But also, I think it’s important to think that just because I don’t think these follow ups are overwhelming doesn’t mean other people won’t.” – REC-03, research nurse

You need to be able to assess whether a participant’s taken that follow-up information onboard (Skills)

“I think every approach is different because you’ve got to look at your setting and your environment and whether it’s appropriate for the person that you’re speaking to as well, so I try to gauge their circumstances, whether they’ve got capacity as well to understand what I’m saying, if I’ll need a consultee, or if it’s even appropriate to talk about research now: have they had some bad news; are they unwell, and all those sorts of things.” – REC-07, research fellow

I am not always confident that I have communicated follow-up effectively as it is difficult to assess a participant’s understanding (Beliefs about capabilities)

“I think there’s some people who really can take that [follow-up discussion] on board and they’re like, “Yeah, no problem, that’s fine,” whereas I think for other people, thinking about that is just too much at that time. Then, obviously, once they’re in the study, then they’ve already kind of signed up for it. Even if you’ve explained it to them and you’ve gone over with it a lot of times, I think it can be quite difficult to know whether they’ve actually really taken that onboard. We spend quite a long time with a lot of these patients, we’ll be with some of these patients for an hour, probably, so I think a lot of people can get almost a bit frustrated with all of the information that you’re trying to give them and they almost kind of get a bit saturated by it.” – REC-02, research physiotherapist

I try to make participants aware of the support they will have throughout the study and that we value their participation (Goals)

“I always explain to them that, you know, even though those… you know, we only see them every six weeks, that their health and safety is really important and I always encourage them to, you know, even if they think it’s minor, I would rather them contact me and me reassure them than them suffer in silence. So, they’re always given that kind of reassurance that they’ve got one person that they can count on…To approach, and I try and be as open as possible to make them feel comfortable and so that they know, you know, I’m here to work with you and help you, and I also stress that, you know, doing a research trial is complimentary to their routine NHS care, and that usually makes them feel quite good as well because they think oh, okay, it’s complimentary and it’s not going to affect their NHS care, so I do try and give them that kind of reassurance and make them feel like they’ve got, not like a friend, but someone that they can confide in and someone that they can be close to, and you know, the fact that we’re always there for them, it’s not like booking a GP appointment, they really like that because they feel like they’re being looked after, so yes, I tend to do that with them.” – REC-16, research nurse

I try to emphasise the voluntariness of participation and their right to withdraw (Goals)

“R—is there anything else that you normally present during those discussions, that you feel falls under that definition, that you can think of?

P – Not particularly, other than the fact that you would be explaining to them that: “You’ve got a right to withdraw at any time, that you can decide at any point at all to withdraw from the study.”

There’s nothing really that I’m probably going to be saying because it’s a bit of a grey area and it can overlap into the… sort of almost influencing someone into staying… coming onto a trial and then staying on a trial. Whereas, I think, it’s important to try to be impartial. It’s difficult. It can be really difficult. And there’s examples… you see examples of clinicians, I suppose maybe almost trying to influence patients, in a way, and it’s maybe not intentional, but I think, for me, I really do try and remain impartial and just really let them know that, “It’s entirely your choice, and then obviously, when you’re on the study, staying on the study, again, it’s entirely your choice. You can withdraw at any time.” – REC-06, research nurse

I am concerned about participants feeling coerced into a trial and I work to remain impartial in my conversations (Social influences)

“It’s just really important to emphasise to the patient that they’re under no pressure, that a lot of patients you know, they think they have to commit to the trial because the doctor’s asked them. So I just like them to know because if the patient feels under pressure and they don’t really want to do the trial, if you recruit them then they’re never going to complete the questionnaires and be retained in the study.” – REC-15, research nurse

I typically feel comfortable discussing follow-up, but it can vary (Emotion)

“R—How do you feel when discussing follow-up with potential participants?

P – I don’t really have any feeling on it. It’s part of the study so it’s one of those things that we have to do, yeah, it’s just normal to talk to them about it

R – Yeah. Ever frustrating or stressful or anything like that?

P – No. I think, you know, if the patient is understanding what you’re saying, then all is fine. Yeah, I’ve not had anyone where I’ve actually felt frustrated by talking about the follow-up.” – REC-09, senior research nurse

A potential participant’s health can impact on what I think is appropriate to talk through with them at consent (Environmental context and resources)

“And with [HOST TRIAL] in this hospital, you kind of get a small window because it’s usually the morning before surgery. They’re hungry, they’ve not eaten. They’re usually going through A&E. They’ve had a lot of information given to them about their [CONDITION], as it is. They’ve got to then adapt to the idea that they may not be [recovered] for six weeks. That they won’t be driving for the foreseeable. It’s a big life changing injury for that point in time. It might not be further on but for this point in time it’s quite life changing. And I think that you’ve just got to – there is ways to present it. And it’s a trial-and-error thing and what one patient wants to hear or needs to hear isn’t the same as another patient. So it kind of like, you’ve got to tailor it to who your audiences is almost.” – REC-03, research nurse

The practices that guide the conversation

I prepare for the discussions, typically by reviewing documents (Behavioural regulation)

“I think normally I give myself a minute just to go and read through everything again and remind myself, and I’ve got all my paperwork. It kind of prompts you and then you’re okay.” – REC-01, research nurse

I have a mental checklist for what I want to discuss (Behavioural regulation)

“I’ve gone through the conversation in my head, and those are things that I would always mention, or they are the things that I would be asked about, so over the years I’ve kind of drafted a mental script of the things that I would like to mention that I think are important out of the consent process.” – REC-07, research fellow

I use certain trial-related documents to guide my conversations (Environmental context and resources)

“Usually, there’s part in the information sheet there would be… if it’s going to be a trial that’s going to go on for a lengthy period of time and that’s a lot of patient involvement, there usually would be a table of events normally and an information sheet. You’d be able to go through that with them and ensure that they knew the level of participation that’s required from them.” – REC-06, research nurse

I use tools like the participant information leaflet to prompt me in discussing certain aspects of follow-up (Memory, attention, and decision processes)

“No, I think that’s part of our normal spiel to patients, to talk about the follow-up. The bit that I find hard is remembering how many weeks or months each one is, but when I go to talk to the patient, I’ll always either check it before or I’ll read it from the patient information sheet when I’m there with them, just to make sure what I’m giving them is accurate information.” – REC-02, research physiotherapist

Personal experience(s) and its influence on future conversations

My confidence in discussing follow-up is affected by how much experience I have (Beliefs about capabilities)

“Yeah, I feel quite confident doing that [discussing follow-up]. Yeah, I do that regularly so I think that comes with the confidence, doesn’t it? The more you do it, the more confident you feel with it, yeah.” – REC-04, senior research nurse

The methods I use to approach follow-up with participants have developed over time (Skills)

“I think the longer that you’ve worked on a trial, the easier it [discussing follow-up] becomes because you get used to the patients that have already been recruited. Sometimes they might have withdrew and gave some reasons why, so you begin to adapt your language almost, and your script that you go through with patients to ensure that you try to reduce withdrawal rates.” – REC-06, research nurse

Difficult prior experiences with participants affects how I approach my current discussions (Reinforcement)

“R – So, do you always intend to discuss your intention when you talk to participants

P – Always, it’s a lesson I learned very early on in my career in research!

R – Okay, and what was that, through some negative experiences or you know…

P – No, it was just I remember we had a participant who didn’t really understand that they had to complete all the study procedures which I thought was very odd considering they signed the consent form, and they said, ‘but you said I could withdraw at any time’, and I said ‘yes, but by signing the consent form you did actually commit to the study’…And, yes, so I’ve had some odd ones over the years and just make it a point of, you know, definitely going through that, so it’s just little things that I’ve learned throughout my career.” – REC-16, research nurse

I reflect on my discussions, either by myself or with the help of colleagues (Behavioural regulation)

“We’ve also tried with a few more of our junior members of staff and getting them to self-reflect on it with somebody else there, so they’ll approach a patient with, say, me watching, and then afterwards we’ll have a discussion and I’ll be asking the person that approached them, “How did you think it went? Anything you thought you could have said better or done better?” etc.” – REC-02, research physiotherapist

I typically do not receive feedback on how I can have effective conversations (Reinforcement)

“I guess we probably all do it in a slightly different way, but having said that, it might be quite challenging to be able to get that feedback because, often, you are in a clinic room and there isn’t somebody else around to listen.” – REC-04, senior research nurse

As I have gained experience in trials, I have found it easier to remember what to discuss about retention (Memory, attention, and decision processes)

“R—So is remembering to talk about follow-up, is that something that’s difficult or easy to do, do you think?

P – I think it’s easy. I think because we know the studies and, I suppose, because we do the follow-up, it’s very much part of what we would be doing and part of the study for us. So yeah, I think mentioning the follow-up is just part of it. You would normally… in conversation even, “I will next see you on the ward with a questionnaire,” or, “I will be posting this one out to you at this time point,” and explaining a little bit, maybe elaborating. “I’ll be sending a return addressed envelope for you to post it back to me.” Kind of talking a little bit more about it. I guess because we do that follow-up, we have that insight into it so yeah, it’s just part of the journey.” – REC-04, senior research nurse

Trial-specific and general work-related factors that influence recruiter’s ability to have effective conversations

The design of the trial affects how I discuss follow-up (Environmental context and resources)

“A&E studies, depends what we’re looking at but for things like PROMS studies, it makes a lot more sense or it’s easier to incorporate follow-up into the conversation because we’re looking at outcomes. We’re explaining to a participant that, actually, “These are patient-reported outcomes so we need you to report your outcomes,” and that’s logical. There are some studies that are, “Actually, we’ve only got one follow-up time point and that’s us contacting you in a year’s time to see how you’re getting on.” It’s quite easy to incorporate that into a short conversation, so thinking about maybe a study that looks at different ECG machines, doesn’t actually impact on the participant very much.” – REC-13, research nurse

My confidence in discussing follow-up is affected by how intense/frequent follow-up is (Beliefs about capabilities)

“We talk through the whole of the schedule of the study when we’re giving out the information. I also go through all of the… you know, what we’re asking them to do as part of the study, so along with being randomised to different arms, we talk about the follow-up looks like. I think with [HOST TRIAL] it’s slightly easier in some ways because the follow-up was them coming and having their treatment and me looking up the notes, rather than having to do a lot of stuff back and forth with clinics.” – REC-09, senior research nurse

The volume and complexity of information I need to cover about a trial can make it difficult to remember everything I might need to discuss (Memory, attention, and decision processes)

“R—Is remembering to talk about follow up and completing the study, is that difficult or easy to do?

P – Oh it’s easy

R – Yes, so you don’t have any issues kind of remembering what you need to talk through?

P – No, never, you know with [HOST TRIAL] it’s quite easy, you know, there isn’t a lot of commitment to the follow up so it’s quite an easy… a fairly easy conversation, I’ve got other studies that are way more involved, and it becomes a bit of an issue, so yes, [HOST TRIAL]’s probably one of the easier ones to have that conversation with.” – REC-16, research nurse

I have other pressures in my job that compete for my attention and memory (Memory, attention, and decision processes)

“R—Is remembering to talk about follow-up and completing the study, is it difficult or easy to do? Is it hard to remember what you need to through or anything like that?

P – It can be, especially if you’re in the middle of thinking about another study and then they maybe let you know that somebody suitable can you either come down and see them or give them a ring, and then you feel like you’re jumping… I know, sometimes I’m like, “Oh, my goodness, which study am I working on just now?” – REC-01, research nurse

If I am under pressure from other work responsibilities or lack of time, it can impact on my discussions (Environmental context and resources)

“I always mentioned that there'll be follow up protocols, questionnaires to fill but whether to the extent of the details which I go with particular patient may vary depending on the time pressures and whatever, just what day is it. So I think I mentioned treatment with everyone but the extent is different.” – REC-05, consultant

My role as a recruiter is determined by who makes the initial approach (Social professional role and identity)

“R—So how does talking to potential participants about follow up and completing the study how does that fit within your role as a recruiter?

P – It’s completely in my role as a recruiter because you don’t want to recruit a patient to a trial and then they don’t follow… then they don’t [complete] the follow up. So it’s hoping when you’re recruiting a patient that the follow up and what’s expected of them when you’re recruiting them, the patient needs to know what’s expected of them. So that’s definitely a conversation, retention and follow up.” – REC-15, research nurse