A clinical decision support system for behavioral health patients treated under the collaborative care model: Protocol for a stepped-wedge, cluster-randomized trial

The Collaborative Care Model (CoCM) integrates behavioral health and primary care using a treat-to-target model involving patient-reported outcome measurements of depression, anxiety, and substance use. Despite the model's effectiveness, patient attrition is common. Our objective is to improve patient engagement with CoCM by implementing a new clinical decision support system (CDSS).

The CDSS, implemented within the electronic health record, is designed to: (a) enhance existing electronic questionnaires (e.g., Patient Health Questionnaire [PHQ-9]; Generalized Anxiety Disorder [GAD-7]) by capturing patient-reported goals and concerns, and (b) visualize questionnaire responses and clinical information on a point-of-care dashboard. Using a hybrid type-1, effectiveness-implementation design, we will evaluate the effectiveness and implementation of CoCM+CDSS on practice- and patient-level outcomes, compared to CoCM in a stepped-wedge cluster randomized trial (three 6-month periods, two practices per cluster). Adults (ages 18+) with depression and/or anxiety are included. The primary effectiveness outcome is increased engagement, measured by the proportion of patients with two or more PHQ-9/GAD-7 assessments. The primary implementation measures assess patient and clinician satisfaction and barriers and facilitators (determinants) of implementation, assessed through semi-structured interviews. Secondary outcomes include response to treatment; shared decision-making, communication, and clinician goal-setting behaviors; acceptability, appropriateness, and feasibility; and reach, adoption, implementation, and maintenance.

The CDSS was designed to facilitate action towards addressing patients' goals and concerns, thereby fostering patient-centered goal-aligned care. Capture of these patient-reported data may be useful for care improvement and informing future comparative effectiveness studies. If effective, the CDSS may be useful in other clinical contexts.

ClinicalTrials.gov: NCT#06898593. Registered: 4/2/2025.