Implementing mHealth for Schizophrenia in Community Mental Health Settings: Hybrid Type 3 Effectiveness-Implementation Trial.

OBJECTIVE: The study aimed to evaluate two mobile health (mHealth) implementation strategies that leverage digital navigators to support deployment of a smartphone intervention for schizophrenia (FOCUS) in community mental health settings. METHODS: A hybrid type 3 effectiveness-implementation trial conducted at 23 community mental health programs compared two implementation strategies that engaged staff and patients in mHealth: external facilitation (EF), a hub-and-spoke model in which digital navigators provide mHealth support to staff and patients at multiple programs, and internal facilitation (IF), in which a frontline staff member at each program serves as the local digital navigator. Implementation outcomes of 3,816 patients with schizophrenia spectrum disorders were intervention reach, penetration, intake completion, and treatment initiation, as well as practitioner ratings of intervention acceptability, appropriateness, and feasibility. Intervention outcomes of 274 enrolled patients were psychiatric hospitalization and emergency department (ED) admissions, clinical symptoms, and recovery (assessed at baseline, postintervention, and 6 months). RESULTS: Both models produced similar implementation outcomes but different intervention outcomes. FOCUS reduced the percentage of participants who experienced psychiatric ED admissions with EF but not IF and produced small positive effects on psychiatric symptom and recovery measures with both implementation models, but the magnitudes of gains were greater in EF. CONCLUSIONS: Despite community mental health center staff's positive impressions of the FOCUS intervention, uptake was low in both mHealth implementation models. Findings suggest a clinical advantage to the EF model. Regional EF hubs can potentially provide support to community agencies implementing mHealth for schizophrenia.