Effective engagement of a stakeholder advisory board in severe mental illness (SMI) research: A case study of a clinical trial to improve adherence among people with SMI and hypertension.

Objective: Poor adherence to antihypertensive medication occurs in 50-80% of patients. An ongoing randomized controlled trial (RCT) is evaluating a personalized mobile-health intervention in poorly adherent hypertensive persons with bipolar disorder. To enhance efficacy, the ongoing trial elicited guidance from a Stakeholder Advisory Board (SAB) comprised of patients, family members, clinicians, and health system administrators. Our goal is to describe the formation, role, decision-making process, and key contributions of the SAB as a means of demonstrating meaningful community engagement in mental health research.

Methods: Using models and measures from the field of implementation science, eleven SAB members convened across three meetings followed by quantitative surveys that assessed SAB member satisfaction and engagement during the meeting.

Results: Significant suggestions from the SAB included 1) expanding inclusion/exclusion criteria, and 2) operationalizing remote implementation of the RCT. Primary study implementation challenges identified by the SAB were 1) participant difficulty engaging in the mHealth intervention, and 2) identification of procedures for monitoring participant adherence to the RCT protocol and contacting under-engaged participants. Quantitative surveys indicated that all SAB members believed that the objectives of the meetings were clear, perceived that they were able to participate in the discussions, and that they were heard.

Conclusions: Increasing evidence demonstrates the feasibility of engaging with SABs in clinical research and that this process improves intervention design, increases participant engagement, reduces mental health-related stigma, and produces more effective implementation strategies. We encourage future investigators to use an implementation science framework in partnership with SABs to refine their proposed interventions and improve clinical outcomes.