Collaborative care for depression management in primary care: A randomized roll-out trial using a type 2 hybrid effectiveness-implementation design.

backgroundThe Collaborative Care Model (CoCM) is a well-established treatment for depression in primary care settings. The critical drivers and specific strategies for improving implementation and sustainment are largely unknown. Rigorous pragmatic research is needed to understand CoCM implementation processes and outcomes.

methodsThis study is a hybrid Type 2 randomized roll-out effectiveness-implementation trial of CoCM in 11 primary care practices affiliated with an academic medical center. The Collaborative Behavioral Health Program (CBHP) was developed as a means of improving access to effective mental health services for depression. Implementation strategies are provided to all practices. Using a sequential mixed methods approach, we will assess key stakeholders' perspectives on barriers and facilitators of implementation and sustainability of CBHP. The speed and quantity of implementation activities completed over a 30-month period for each practice will be assessed. Economic analyses will be conducted to determine the budget impact and cost offset of CBHP in the healthcare system. We hypothesize that CBHP will be effective in reducing depressive symptoms and spillover effects on chronic health conditions. We will also examine differential outcomes among racial/ethnic minority patients. DISCUSSION: This study will elucidate critical drivers of successful CoCM implementation. It will be among the first to conduct economic analyses on a fee-for-service model utilizing billing codes for CoCM. Data may inform ways to improve implementation efficiency with an optimization approach to successive practices due to the roll-out design. Changes to the protocol and current status of the study are discussed.