Multilevel Community Engagement to Inform a Randomized Clinical Trial

Abstract

Objective: To explore how patients, community-based perinatal support professionals, and health system clinicians and staff perceived facilitators and barriers to implementation of a randomized clinical trial (RCT) designed to optimize Black maternal heart health.

Methods: This article describes the formative work that we believed needed to occur before the start of the Change of H.E.A.R.T (Here for Equity, Advocacy, Reflection and Transformation) RCT. We used a qualitative, descriptive design and community-based, participatory approach, the latter of which allowed our team to intentionally focus on avoiding harm and equalizing power dynamics throughout the research process. Data were collected between November 2021 and January 2022 through six semistructured focus groups that included attending physicians and midwives (n=7), residents (n=4), nurses (n=6), support staff (n=7), community-based perinatal support professionals (n=6), and patients (n=8).

Results: Four primary themes emerged. The first three themes were present across all groups and included: 1) Trauma in the Community and Health System, 2) Lack of Trust, and 3) Desire to Be Heard and Valued. The fourth theme, Hope and Enthusiasm, was expressed predominantly by patients, community-based perinatal support professionals, residents, and support staff, and less so by the attending physician group.

Conclusion: Participants articulated a number of key sentiments regarding facilitators and barriers to implementing Change of H.E.A.R.T. We noted variability in perceptions from different groups. This has important implications for health equity efforts in similarly underresourced health systems where Black birthing people experience the greatest morbidity and mortality.

Clinical trial registration: ClinicalTrials.gov, NCT05499507.

Fig. 1.. Complexity of theme 1: traumatized system. Covid, coronavirus disease 2019.