In the GoodNEWS trial we have used a CBPR approach for reducing the risk of CVD among African-American individuals in the congregational setting. Our experience provides valuable lessons related to four specific challenges we encountered conducting a clinical trial in the community setting. Typically, CBPR challenges tend to revolve around the interpersonal dynamics of reconciling academic and community priorities — e.g. developing equitable social relationships between researchers and community stakeholders, building trust between the partners, sharing power, and developing open communication [54
]. However, since the GoodNEWS program has existed in the target community since 2003, the academic-community partners had already developed a robust partnership by the time the trial began in 2007 and the challenges tended to be more related to actually implementing the trial rather than developing or navigating relationships.
The first challenge faced by the team was recruiting congregations to participate in the study. The original recruitment plan proposed: 1) identifying eligible congregations using an existing directory of 800 area congregations as the sampling frame, 2) sending a program brochure and letter of invitation from the GoodNEWS Pastor’s Advisory Council (PAC) to the Pastors of eligible congregations, 3) contacting Pastors with a phone call from program staff and a follow-up phone call from a member of the PAC, and, 4) extending an invitation to an informational luncheon, where the program and the study would be described and interested Pastors could sign a letter of intent to participate. However, the process took almost twice as long to complete as we had planned; many times Pastor’s beyond the immediate circle of our PAC member friendships requested face-to-face meetings before coming to an informational session, we had difficulty getting our information on the agenda of local church congregation associations since the agendas were sometimes made several months in advance, and holidays such as Thanksgiving and Christmas fell in the middle of the recruitment period.
In light of the slower than expected pace of recruitment, we contracted with a local community consultant to help us revise our recruitment plan. The consultant began contacting congregations on our behalf, arranged for the principal investigator and senior research nurse (who were already well known in some segments of the community) to appear on local radio shows to discuss the project, and arranged for local community newspapers to run feature stories on the project. Although the revised strategy was ultimately successful, in retrospect – even though the program staff had strong existing relationships in the community – we would have likely saved time and improved efficiency by contracting with a local social networking consultant at the outset of the recruitment period.
The second unanticipated complication was the need to conduct two LHP training sessions, rather than only the one that had been planned originally. Only 13 of the 23 (57%) congregations recruited and scheduled to participate in the training program actually did participate as scheduled, and five of the ten who did not participate eventually declined continued participation altogether. Most of the reasons given for not participating in the scheduled training were related to personal problems encountered by the LHPs themselves, such as loss of a family member, illness, or some other unforeseen circumstance, or a feeling that they had overcommitted and did not realize the full extent of their commitment. Although, LHPs and their Church Pastors’ had been informed repeatedly in person, on the telephone, and through email, it was clear that some of the participants still did not have a clear understanding of the program requirements.
The need for extending recruitment and conducting a second training program produced both negative and positive effects. On the negative side, it contributed to another recruitment-related delay to the project timeline. However, on the positive side it allowed the project team to become very familiar with the training materials and to begin working together more closely before randomization and putting the intervention in place. The delay contributed to bonding the team members more closely together, and to developing a positive team culture related to addressing and overcoming the challenges of working with people in the real-world community setting. In future programs we plan to convene all of the community partners’ leaders – LHPs, Pastors, and other relevant church staff – to fully understand each other’s commitments and responsibilities. Although we had explained these components with the Pastor and the LHPs in the group setting, the extra time needed for conducting individual meetings in congregations, might be more efficient and less time consuming in the long run than extending the recruitment process and conducting another LHP training session.
The third challenge we encountered was related to planning the community-based measurement events, which was more complicated than originally envisioned. Since the events were based in the community, they required storage space for the measurement materials – including refrigeration – throughout the four-week measurement period. Additionally, separate rooms were needed for each measurement station, kitchen facilities were needed for providing a light breakfast since fasting glucose measurements were obtained, accessibility by car and bus was needed (along with parking), and crowd flow inside the event venue. When the program staff began planning the event it became clear to us that we would need the advice of a professional event planner familiar with the target community and suitable venues. The relatively modest amount of funding required for contracting with an event planner is highly recommended; the arrangement allowed the project staff to focus measurement planning needs while allowing the event planner to focus on the community and venue interface. The major consideration we learned from the event planner is the importance of developing a crowd-flow plan for a five-hour event when a large group of participants is expected to arrive at the same time, and when some of them will require immediate measurement and breakfast related to their medication schedule. Event planners are trained in and experienced with anticipating and accommodating these needs, and the joint planning between an experienced community event planner and CBPR project manager provided an excellent partnership for conducting a highly efficient community-based measurement event.
The final challenge that was not anticipated by the event planner or the research team was the need for conducting an additional measurement event beyond the four that were already schedule. We expected that two Saturday and two Wednesday events, would allow sufficient time and planning for all enrolled WCMs to attend regardless of conflicting schedules. The additional measurement event was needed even after advertising the measurement dates for 3 months in advance through personal meetings at the churches attended by program staff, telephone calls to the LHPs who then contacted by phone their respective WCMs, announcements in the church bulletins, announcements by the Pastor from the pulpit on Sunday mornings, and bi-weekly emails delivered to those who enrolled during their churches’ recruitment events. Our experience indicates that participants need to be instructed even more thoroughly about their roles and responsibilities, and the instruction needs to be reinforced beyond providing event reminders.
The experience of the GoodNEWS trail indicates that it is necessary when conducting community program and measurement events, to schedule back-up or contingency events as part of the planning process. Research requirements – no matter how well explained, planned, executed, or important from the research perspective – do not easily fit into the planning calculus and timeline of community members. Our experience also supports the need for incorporating non-traditional community-based staff into the design and operational plan of CBPR trials, including a community recruitment consultant and event planner. Even though two members of the core project team were actually from the target community, having a consultant and event planner from within the target community provides even greater insight into the pace and process of integrating a clinical trial into the community context and greatly improves efficiency.