Addressing opioid misuse through community-engaged strategy development: study protocol of a randomized controlled trial

Background: Involving stakeholders in the research process facilitates collaboration, increasing understanding of factors influencing their wellbeing and motivating community action. Currently, there is a need for randomized controlled trials to evaluate the effectiveness of community-engaged research approaches for health, well-being, and engagement outcomes. In this study, we evaluate the effectiveness of both the SEED Method and a modified Delphi method in a participatory project to develop local strategies to address the opioid epidemic in three rural communities. The purpose of this study is to increase the level of evidence for community-engaged research methods through a randomized controlled trial. Methods: Two communities will use the SEED Method and one will use a modified Delphi method. We aim to recruit a total of 144 participants (48 per community). The evaluation team will randomize participants to an intervention group or a control group. In addition, we will collect outcome data from the participatory research team members leading the projects in each county (n = 18) and from additional community members who participate in focus groups (n = 32). The primary outcome for all participants will be the change in self-reported civic engagement as measured by the total score on the Individual Mobilization Scale.

Discussion: In the context of participatory action to address opioid misuse in rural counties, this study will provide an understanding of the effectiveness of two community engagement methods for increasing civic engagement, as well as the extent to which participants successfully create locally tailored action strategies. The study will also explore how the observed effects differ depending on the participant’s role in the project (stakeholder participant, community research team member, or focus group participant), which is an important consideration for participatory research.