RATIONALE: Few coronary heart disease (CHD) patients engage in evidence-based depression treatments (ie, antidepressants, therapy, exercise). We present the protocol and analysis plan for a hybrid type II effectiveness-implementation trial evaluating the impact of a theory-informed, multilevel implementation strategy centered around an electronic shared decision making (eSDM)/patient activation tool. DESIGN: The IHEART DEPCARE Trial uses a pre-post single group, open label design with 4 sites (each with a cluster of cardiology clinics and a cluster of primary care clinics, 8 clusters in total) introduced to the multilevel strategy (ie, single arm) in random order with patients (a pre-implementation cohort and nonoverlapping post-implementation cohort) nested within clinicians, nested within clusters. All primary care and cardiology clinicians at participating clinics are included. The patient sample includes English- and Spanish-speaking CHD patients ≥21 years of age with screen-detected elevated depressive symptoms (ie, Patient Health Questionnaire-9 score ≥10) and a scheduled visit during the relevant time period. In the pre-implementation period, CHD patients receive usual care. At the start of each implementation period, a site's behavioral health providers (BHPs) and clinic administrators are invited to problem solving meetings
patients receive an eSDM and patient activation tool that includes psychoeducation, patient activation, and treatment selection support
and clinicians/BHPs receive a summary report of patients' preferences (implementation strategy). During pre- and post-implementation periods, patients are assessed at baseline and 6 months for depressive symptoms, depression treatment intensification, health-related quality of life years, and (at baseline only) patient activation and decisional conflict. The primary effectiveness outcome is change in depressive symptoms from baseline to follow-up during the post-implementation period compared to pre-implementation period. Key trial design changes, relative to our initial pre-COVID-19 trial protocol, include transition from a stepped wedge design to a single pre- post design randomized to strategy timing, reduction of exclusion criteria, options to bypass clinicians for direct BHP referrals (vs reliance on referrals) and addressing multiplicity in our statistical analysis plan. The trial was launched in April 2019 and is estimated to conclude by July 2025. DISCUSSION: The IHEART DEPCARE Trial is the first hybrid type II effectiveness-implementation trial to examine the effect of a brief, theory-informed eSDM and patient activation tool strategy on depression treatment uptake and symptoms in CHD patients. Our protocol advances the field of implementation science by incorporating a multilevel (vs single-level) implementation strategy to address depression, highlighting unique challenges of stepped wedge designs and hybrid effectiveness-implementation trials, and demonstrating alternative design approaches.