Table 1 Themes and sub-themes identified in interviews of recruiters to the SAVER study. Sub-themes categorized according to Barriers (B) and Drivers (D), including frequency and relevant TDF domain (n = 9)
Theme | Sub-theme | Frequency (out of 9) | TDF Domain | Representative Quote |
|---|---|---|---|---|
Coordinating between people | Coordination between other recruiters and physicians is essential to success | D: 9 | Behavioral regulation | “There’s a group of us and we are on a rotation schedule. So the day before you screen through the clinics to identify potential patients and that one person does it so that it’s not 15 coordinators going through the same list of patients.” |
Physicians are seen as essential to recruitment; especially reminding physicians about the study and physician buy-in | D: 9 | Behavioral regulation; social influences | “I find I’m more successful at recruiting patients into research with certain physicians.” “So the physicians who are first asking the patients if they would like to talk to us. If they have bought into the study then I see a higher percentage of patients who will ultimately say yes…” | |
Recruiters rely on others to initially approach patients | D: 9 | Social influences | “Having people that are educated enough on the inclusion/exclusion to identify these people is key because we cannot speak to somebody if they have not identified them in the first place.” | |
Having a (non-physician) screener identify patients to recruiters | D: 7 | Social influences | “We actually have another casual research nurse. So yeah they are screening clinics the day before and highlighting any possible potential patients for the, the person working the following day.” | |
Physicians sometimes have their own inclusion/exclusion criteria (e.g. age) | B: 1 | Beliefs about capabilities | “They [physicians] have like arbitrary kind of cut-offs for patients as far as maybe age like I’m not gonna [sic] refer anyone over 70 years old or, you know, something like that which is not an exclusion.” | |
Competing studies can result in non-recruitment | B: 1 | Motivation & goals | “When we have the big pharma studies they it’s more of a, a high I guess to put patients into those studies in comparison to a smaller study like SAVER.” | |
Providing guidance to recruiters about challenges | Recruiters say they did not receive formal training | B: 7 | Skills | “I was trained on the protocol and trained on like so that I guess would be given the information, the skeleton information to do the consent process. But not really trained.” |
Recruiters report feeling frustration/disappointment when recruitment does not go well | B: 6 | Emotion; beliefs about consequences | “You really get down on yourself. You feel like a failure, a bit of a fraud in kind of what you are doing.” | |
Recruiters feel they would benefit from training | B: 5 | Skills | “I think it’s a good idea for people that are newer to go in, of course, with, with somebody that’s done it before to, to just to listen to the spiel.” | |
Deciding not to recruit because they feel patient is not understanding the study | B: 2 | Memory, attention, decision process | “If you start to get a feeling based on the questions that they are asking you or the responses they are giving that maybe they cannot really be quality consenting.” | |
Deciding not to recruit because patient is unpleasant/aggressive | B: 2 | Memory, attention, decision process | “… they are violent in the ER. You know what I mean? … not to say that we should not recruit those patients but it can be difficult from a coordinator standpoint to include them in, in the study.” | |
Providing resources to recruiters | Having recruitment goals is motivating | D: 8 | Motivation & goals | “So we have our monthly targets.” |
Knowing personal recruitment numbers is helpful | D: 8 | Knowledge | “There’s tons of information about the number of patients you are screening/month, the number of patients you, you are recruiting/month which is all fairly accessible.” | |
Having a backup recruiter is important | D: 7 | Environmental context/resources | “…and we have backups like every study, every person has backup so like I’ll back up her study, she’ll back up my studies…” | |
Recruiters feel they have appropriate reminders in place, and that such reminders are essential | D: 5 | Memory, attention, decision process | “Once they leave the, once they leave the hospital then it’s all up to the coordinator to remember to follow up with them. So I, I try to use Outlook to be honest with you. I put, I’ll put reminders.” | |
Having access to appropriate room/space for recruitment is important | D: 7 | Environmental context/resources | “We have a really good clinic upstairs so everyone has this, this availability. So we actually have 2 rooms that are set up for research, 2 clinical rooms…” | |
Competing with other recruiters/sites is motivating | D: 3 | Social influences | “If I see that external sites are doing better than yeah I have that competitive kind of side of me that wants to increase numbers.” | |
Insufficient time for recruitment | B: 3 | Environmental context/resources | “I think the only resource that I’m lacking is time.” | |
Inadequate access to space | B: 2 | Environmental context/resources | “We do not have extra space in our clinic like another room that we can take patients to, to go through consent and stuff like that.” | |
Using visual aids (i.e. posters) to facilitate patient understanding | D: 2 | Behavioral regulation | “So we have a visual diagram that … describes post thrombotic syndrome and has pictures. So that is a tool that I often point to for the patient. I always find that visual aids are helpful and one of the secondary outcomes that they are looking for in this study is preventing that.” | |
Visual aids were developed but unused as not REB approved | B: 2 | Behavioral regulation | “So he created a, which he will have told you, is a 2-page study aid. I do not bring it in because we did not get REB approval for using it, but I basically highlight it in my conversation…” | |
Physical location noted as a barrier until changed for co-location with study physicians | B/D: 1 | Environmental context/resources | “Now we are all in one location and it seems to be a lot better… it’s much easier to speak about potential patients if you meet them in the hallway where it wasn’t necessarily happening before.” | |
Optimizing study flow | Allowing the consent forms to go home for a later decision | B:3;D:1 | Nature of the behavior | “So those patients sometimes will take it home and come back which I, I do not like because I think there is—the ability to recruit those patients becomes a lot harder once they have, they have left and they have to come back.” |
Time pressure felt by recruiters (1-month window) | B: 3 | Nature of the behavior | “Well you have to consent patients within one month of diagnosis of clot.” | |
Requiring a consent decision right away | B: 2 | Nature of the behavior | “The problem with SAVER and some of these studies is that you have to consent now. You do not, you know, we cannot push it back a week.” | |
Tests required to assess eligibility sometimes interfere with time window | B: 1 | Nature of the behavior | “SAVER trial in particular there’s a few hoops you have to jump through. You have to have some baseline blood work to see that they are eligible.” | |
Guiding the recruitment discussion | Recruiters are aware of the importance of patients’ understanding and ask questions to ensure they understand (informed consent) | D: 9 | Behavioral regulation | “I think the most one of the most important things for retention in recruitment would be patients’ understanding … to determine whether they actually understand what they are reading is obviously very important.” |
Emphasizing the minimal burden for patients is a successful recruitment strategy | D: 4 | Behavioral regulation | “I also try and stress on my end the way that I’m flexible to make it not a burden on them. So if it, you know, follow-ups are all done by telephone and you’ll not have to come back for extra visits that tends to be the biggest burden for patients is having to return to the hospital …” | |
Recruiters feel that not rushing a decision from patients is important | D: 4 | Behavioral regulation | “I would try to avoid rushing the patient. I, you never want to make them feel like they are rushed at all…” | |
Emphasizing the benefits of participation | Informing patients that a nurse will be readily available during the study facilitates consent | D: 7 | Behavioral regulation | “…that they have someone to call if they have any concerns and we can get them into clinic more much more quickly.” |
Recruiters suggest participation will provide patient with a sense of control over their condition | D: 5 | Behavioral regulation | “And sometimes when you cannot control your disease or your illness this is a way of controlling. You get to choose. I’ve sold it that way too.” | |
Reminding patients that participation would help others | D: 4 | Behavioral regulation | “That they are taking part in something where they could truly benefit and it’s also helpful for people down the road who will develop VTE.” | |
Study design facilitates recruitment (i.e. no placebo) | D: 2 | Beliefs about capabilities | “Something that made me more confident is the fact that we are not using placebo in this study.” |