A Hybrid Type 1 trial of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with serious mental illness: Study protocol

Background The transition from acute (e.g., psychiatric hospitalization) to outpatient care is associated with increased risk for rehospitalization, treatment disengagement, and suicide among people with serious mental illness (SMI). Mobile interventions (i.e., mHealth) have the potential to increase monitoring and improve coping post-acute care for this population. This protocol paper describes a Hybrid Type 1 effectiveness-implementation study, in which a randomized controlled trial will be conducted to determine the effectiveness of a multi-component mHealth intervention (tFOCUS) for improving outcomes for adults with SMI transitioning from acute to outpatient care. Methods Adults meeting criteria for schizophrenia-spectrum or major mood disorders (n = 180) will be recruited from a psychiatric hospital and randomized to treatment-as-usual (TAU) plus standard discharge planning and aftercare (CHECK-IN) or TAU plus tFOCUS. tFOCUS is a 12-week intervention, consisting of: (a) a patient-facing mHealth smartphone app with daily self-assessment prompts and targeted coping strategies; (b) a clinician-facing web dashboard; and, (c) mHealth aftercare advisors, who will conduct brief post-hospital clinical calls with patients (e.g., safety concerns, treatment engagement) and encourage app use. Follow-ups will be conducted at 6-, 12-, and 24-weeks post-discharge to assess primary and secondary outcomes, as well as target mechanisms. We also will assess barriers and facilitators to future implementation of tFOCUS via qualitative interviews of stakeholders and input from a Community Advisory Board throughout the project. Conclusions Information gathered during this project, in combination with successful study outcomes, will inform a potential tFOCUS intervention scale-up across a range of psychiatric hospitals and healthcare systems.Clinicaltrials.gov registration: NCT05703412