Collaborative Care Model for Perinatal Wellness Support Services – Population-Level Upstream Systems Change (COMPASS+): A Hybrid Type 2 Cluster Randomized Trial

Perinatal mood and anxiety disorders (PMADs) are the most common complication of pregnancy, affecting 600,000 to 900,000 birthing people in the United States annually. Less-than-optimal outcomes necessitates innovations in care delivery to better meet the needs of birthing people. The perinatal Collaborative Care Model (pCCM) represents one promising approach to improving patient outcomes. The pCCM includes a Care Manager, patient registry, and weekly clinical huddles, collectively designed to reflect the committment to ensuring all patients referred to the pCCM achieve remission of their mental health symptoms. While CCMs show great success in Primary Care settings, research on their efficacy in obstetric clinics is limited. In addition, while the CCM is an acceptable and accessible model of care, community based participatory research practices can optimize these implementation outcomes by centering the voices of the community the program intends to serve. Community engagement has led to the creation of an adapted version of the pCCM, COMPASS PLUS (Collaborative Care Model for Perinatal Wellness Support Services - Population Level Equity-Centered Systems Change). Herein, we describe the design of a stepped wedge randomized trial with an effectiveness-implementation design to assess the effectiveness of COMPASS+ and evaluate implementation strategies for the COMPASS+ model.