Danielle Jake-Schoffman, Ph.D., assistant professor in the Department of Health Education and Behavior and the director of the EXHALE (EXercise and HeALthy Eating) Lab
September 24, 2021
Dr. Jake-Schoffman’s latest study in the American Journal of Preventive Medicine, “Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance,” looks at how an in-depth orientation for prospective participants can benefit clinical trials of behavioral interventions. The approach incorporates elements of motivational interviewing, a counseling technique to support behavior change in individuals experiencing ambivalence. Having previously worked on retention methods for engaging participants and seeing the challenges first hand, she and additional collaborators report in a recent paper about applying the orientation session approach, originally developed and described by study co-author Michaela Kiernan, Ph.D., senior research scholar at Stanford Prevention Resarch Center, to three ongoing weight loss trials.
In trials we always want to aim to have equal attendance and retention or the number of people who stay in a study through the end. That helps us understand that what we're seeing in our results is maybe because of the interventions as opposed to because people didn't, for example, like the control group, or they found it boring, and they dropped out.
In the past, it’s [poor retention] really plagued weight loss trials. It can be particularly challenging for any health behavior change, because what we're asking people to do is change their lifestyle and that can be hard to maintain. Folks who are not doing as well are less likely to return and that can really skew their results in terms of understanding the true effectiveness of a program. But also, critically, it doesn't help us learn about what we need to change, because people for whom a program didn't work are exactly the people we want to talk to. [We want to ask,] ‘How do we need to adjust our interventions so that they can be more effective for more people in the future?’
Seeing the evolution of this [orientation approach] across studies that I was involved in made me get very interested in better systematically describing these potential impacts of the orientation session on attendance and retention. Working together with this team, we identified three studies where the orientation session approach was implemented in ongoing trials. To date, this is the closest we've come to an experimental test of the impact of the orientation sessions.
There are four key constructs that we cover within the orientations, which are held before participants are randomized to a condition. One is setting really clear expectations for participants and making sure that they understand that we're transparent about all the procedures that they'll be undergoing. This is where we try to describe the research question and why we think it's compelling.
The next part of the orientation session is understanding scientific principles behind the methods. We try to explain a little bit more about what randomization is, for example, and why we need to randomize to ensure that the conditions are balanced across a number of factors.
We make a non-judgmental space for people to be able to discuss the two conditions, which leads into the third component which is the one that's most directly informed by motivational interviewing. That's where we try to explicitly diffuse people's ambivalence about participating in the trial and about participating in one of the two conditions preferentially. So we have a structured discussion about the pros and cons of being in the two conditions or the trial. We try to engage participants to think through the implications of each of those decisions and explore if they truly are willing to participate in either condition or the trial.
The last kind of component is trying to ask people to make two commitments: one is to themselves and to trying to fulfill their own goals within the trial. The second is making a commitment to the trial, and remaining engaged in the trial assessments, regardless of their personal progress. They're both important, but they're separate.
Some studies do have more deception involved in them. But I think we would argue that participants are smart. They're savvy and they understand more about what's happening than what we necessarily always are describing to them. It’s important to be straightforward about some of the scientific questions that you are really interested in testing. The onus is on us to provide accessible education to participants so that they can understand that it's free of scientific jargon. We see that when people are unsure, confused, or they don't understand the extent of the commitment that they're making, that those folks don't tend to stay long term in a trial. And that doesn't benefit anyone.
The takeaway is that across these three very diverse trials and trial samples, and delivery methods of the orientation session (e.g., in-person, webinar, conference calls), we saw improvements in participant engagement (via retention at assessments and trial attendance) after implementing the orientation sessions. It's really powerful because the way that the interventions and the orientations were delivered is different across the groups. So you know it wasn't just one specific population. All found an impactful change from a relatively simple procedure to add to a trial.
When people have gone through these orientation sessions, it really provides a baseline of understanding and kind of education around all of those components that we can draw on again later. I definitely have noticed some positive kind of enhancement in the participant understanding and willingness to at least have discussions about remaining engaged in the trial and assessments. We really think that these orientation sessions are having these impacts, and that they may be leading to greater education about the research methods.
A potential next step in this area of research would be having a trial and randomizing people to attend an orientation or not attend an orientation, and seeing if it impacts trial outcomes and participant engagement (retention and attendance). But that's not very practical especially if you truly believe that this orientation session is going to boost outcomes and engagement. It's hard to justify not providing the information to all participants.
We also encourage researchers to consider embedding smaller experiments, such as those that might help us measure the potential impact of the approach on participant trust and feelings of respect in the research process. We outline some additional ideas for future research in our paper.
Yes. I'm very excited to spread the word about it. I'll be giving a webinar about retention later this month through the University of Connecticut Center for mHealth and Social Media. The author team for the article is disseminating it broadly including with NIH program officers. We really hope that researchers will pick it up broadly and find ways to use it in their own work.