Adaptation of Methods-Motivational Interviewing Approach
An adapted Methods-Motivational Interviewing (MMI) approach, incorporating a prerequisite orientation, was implemented in the recruitment stage of a pilot trial assessing the feasibility and exploratory outcomes of a culturally tailored diabetes self-management intervention versus a standard diabetes program for Black adults. The prerequisite orientation took place before the informed consent process, featuring a 20-minute in-person interactive presentation led by the principal investigator and a 15-minute small group discussion led by the study coordinator. Informed by the core constructs of the MMI approach by Jake-Schoffman et al., 20 we tailored our interactive presentation to include: (1) the meaning of research and the purpose of clinical trials, (2) an introduction to randomization and the process of randomization, (3) an overview of the study clinical trial and differences between the two trial arms, (4) the study timeline including assessments, time involvement, and incentive schedule, and (5) an explanation about the scientific rationale for completing assessments.
Following the interactive presentation, the principal investigator left the meeting room the orientation was held to mitigate power dynamics. Thereafter, the study coordinator facilitated group discussions with potential participants using motivational interviewing principles. Specifically, the facilitated group discussions prompted potential participants to think of two pros and cons for participation in the trial. Since our trial comprises two trial arms, each receiving one type of diabetes self-management program, the study coordinator also asked the potential participants to generate an additional two pros and cons for ‘being in the 6-week group’ and ‘being in the 8-week group’. After the brainstorming session, the study coordinator allocated an equal amount of time to allow potential participants to share their opinions on each scenario (e.g., pros of being in the trial, cons of being in the trial, etc.) to sustain neutrality regarding trial participation.
Applications of Health Literacy Principles in Designing an Interactive Orientation
The prerequisite orientation was developed following health literacy principles in engaging with potential trial participants. 26 The visual aids and key strategies we used in the initial 20-minute interactive presentation are demonstrated in Table 1. The interactive presentation incorporated five main topics, including (1) an introduction to research and trial, (2) an introduction to randomization, (3) an overview of the program, (4) the study timeline and expectation, and (5) explanation of scientific rationale for completing assessments.
In the first topic of the presentation, we began by defining ‘research’ to our potential participants, introducing synonymous terms such as clinical trials and clinical studies. We explicitly mentioned that we could use the terms interchangeably throughout the entire study. Additionally, we explained the purpose of conducting various types of research, providing examples and visual aids to enhance participant understanding of the topics. Our presentation specifically introduced behavioral research and illustrated how this type of research would be conducted in a community setting for our audience, and how it differed from other type of trials.
Following the introduction to research and variation in clinical trials, the second topic explained ‘randomization’ to our potential participants. In this segment, we elucidated the process, beginning with potential feelings (e.g., feeling unfair) that participants might experience. We clarified how researchers handled the assignment of participants in a study, outlining methods such as using flip coins or computer-generated programs. Additionally, we provided the rationale behind this process. 27 To ensure simplicity, we used plain language, visualized the procedure, and illustrated how human choices could introduce bias into trial results, offering a straightforward example for better understanding. Finally, we connected how randomization allows for trustworthy results that would minimize bias in the final study outcomes.
In delivering the main content of study information, we provided potential participants with relevant background information about the prevalent health-related issues in the Black community. For cultural appropriateness, we acknowledged possible mistrust experienced in healthcare/research settings when introducing the purpose of this study. With well-designed visual aids, we presented only the essential information about the intervention components. For instance, we organized group education sessions and support by diabetes self-management topics. Throughout the presentation, we aimed to remain neutral regarding the effectiveness of the two trial arms. We avoided emphasizing culturally tailored support in one of the trial arms, instead focusing on the format of support participants would receive in the intervention group. To enhance clarity, we used colors to highlight the similarities and differences between the two trial arms, ensuring that the information was easily understandable for potential participants.
Following the general overview of the study information, the next topic delved into more detailed study procedures by specifying the expectations associated with each study event. To enhance understanding, we employed a pictorial roadmap that mirrored the structure of the study timeline while incorporating layers of information. This included details such as the number and types of study assessments, the time involved in each assessment or intervention, and the payment or incentive schedule provided at different phases. Importantly, we emphasized to potential participants that they still had the option not to participate in the trial. It was crucial for them to understand that this decision would not impact their usual care.
The final topic of the presentation focused on elucidating the scientific rationale for retaining participants during the overall study. An infographic design informed by Kiernan et al. 28 was applied to enhance knowledge of the scientific rationale, provide transparency, and share the value of its scientific contribution. Adapting the visualization to the two trial arms in our study, we explained how different scenarios could impact the 'true' study results. Our goal was to demonstrate the importance of participant retention in obtaining meaningful and accurate data. Additionally, we wanted to establish trust with potential participants by being transparent about our purpose to only accept unbiased results of the study.
Subsequently, we implemented several strategies to diffuse ambivalence about study participation. We intentionally used open-ended questions at the end of each topic (e.g., What questions do you have for me? What part of the procedure needs more explanation?) to encourage potential participants to engage in the discussion. An interactive group discussion about the pros and cons of participating in a trial enhanced potential participants’ understanding of the study’s key information of the study but also fostered a safe environment to share their concerns. All methods were carried out in accordance with approval of the Health Sciences Institutional Review Board of the Principal Investigator’s University (2022 − 0879).
Data collection
During the 15-minute small group discussion, to discuss the pros and cons of participating in the trial, potential participants in the groups took turns sharing their thoughts with the whole group. Discussion notes were documented by two research assistants and summarized across different screening/orientation days. After the trial started, two 30-minute focus groups – one with the intervention group and one with the control group, were conducted by the study coordinator to gather participants’ feedback on the prerequisite orientation and explore their perceptions of the enrollment process. The coordinator has extensive experience in facilitating focus groups and maintained a neutral stance in gathering participants' feedback on the prerequisite orientation. We also collected quantitative measures, including trial enrollment and retention rates using study documents review. While there are no standard criteria for enrolling and retaining participants in Black adult populations, we set the target based on our previous work – enrollment rate of 80% and retention rate of 75%.29 The attrition rate was set as 20% after randomization. Our anticipated time from the initial screening to enrollment was 60 days.
Data analysis
Participant demographic information, recruitment and retention rates for the trial were analyzed using descriptive statistics. Discussion notes, gathered from each screening day, were summarized through document review. Focus group transcripts were analyzed by one research assistant using inductive content analysis. 30 For qualitative analysis, NVivo 10 (Lumivero) was used to organize the codes and themes from the focus group transcript and keep audit trails. Data triangulation with observations and focus groups at different time points was implemented to ensure the credibility of this qualitative study. 31