Achieving cardiovascular health equity in community mental health: study protocol for a cluster-randomized hybrid...

People with serious mental illness die 10-20 years earlier than the overall population, mainly from cardiovascular disease. Although effective interventions to manage cardiovascular disease risk in this population exist, they have not been widely implemented in community settings. IDEAL Goals is an empirically supported, cardiovascular risk reduction program tailored for people with serious mental illness (i.e., "clients") and designed to be delivered by clinicians and staff in community mental health settings. In this trial, we use Replicating Effective Programs (REP) as the foundational implementation strategy to test the effects of two additional strategies, Coaching and Facilitation, on improving the number of IDEAL Goals sessions clients receive in community mental health organizations in Maryland and Michigan.

This cluster-randomized hybrid Type 3 effectiveness-implementation trial will use a non-restricted sequential, multiple-assignment randomized trial (SMART) design that randomizes organizations at two points, months 0 and 6, of the 18-month IDEAL Goals intervention. Organizations will receive one of four sequences of implementation strategies: (1) REP only; (2) REP + Coaching; (3) REP + Facilitation; or (4) REP + Coaching + Facilitation. The primary aim is to determine the effect of the most intensive sequence of strategies (REP + Coaching + Facilitation) versus REP only on the number of IDEAL Goals sessions clients receive over 18 months. The secondary aim is to determine the marginal effects of Coaching and Facilitation on the number of IDEAL Goals sessions clients receive over 18 months. Exploratory aims include: (1) assessing tailoring variables to inform a future adaptive implementation intervention to scale IDEAL Goals; (2) estimating the cost of delivering IDEAL Goals and implementation strategies; and (3) examining the relationship between different sequences of implementation strategies on: clients' receipt of cardiovascular disease risk factor management processes and outcomes over 18 months; and clients' receipt of IDEAL Goals over 30 months. Qualitative efforts will explore implementation strategy mechanisms, adaptations, and participants' experience of delivering and receiving IDEAL Goals.

To meaningfully reduce premature mortality for people with serious mental illness, it is imperative to test strategies that can facilitate optimal uptake and continued sustainability of cardiovascular risk reduction programs in community settings.

ClinicalTrials.gov identifier: NCT06674616 , registered on November 1, 2024.