Schizophrenia spectrum disorders (SSD) are a major public health concern. Evidence-based illness management interventions can extend the recovery periods and improve the outcomes of people with SSD but these are seldom available at community mental health clinics (CMHCs) where the majority of individuals with SSD receive care. Widely available mobile technologies can help overcome the capacity constraints of CMHCs, expand the reach of evidence-based mental healthcare, and provide much needed illness management skills and resources for people with SSD, wherever they may be. FOCUS is a Mobile Health (mHealth) illness-management system specifically designed for people with SSD. A series of studies conducted with over 500 participants with SSD across ten states has shown that FOCUS is feasible, usable, engaging, and effective. CMHC clinicians and administrators express a strong interest in integrating FOCUS into their offerings and workflow. While FOCUS is well-poised for deployment, how best to implement mHealth interventions in real-world community care settings is unclear. Two Practice Facilitation strategies may be suitable for implementation of FOCUS in CMHCs: External Facilitation (EF) and Internal Facilitation (IF) approaches. We propose to conduct a comparative effectiveness prospective cluster randomized hybrid type 3 trial to compare EF vs. IF implementation of the FOCUS intervention in 20 CMHCs in Washington State. Specifically, we aim to 1. Evaluate and compare implementation outcomes; 2. Examine moderators (i.e., readiness for change, culture, urban vs. rural status) and mediators (absorptive capacity) of implementation effects; and 3. Evaluate and compare patient outcomes, including evaluation of intervention mechanism of action. We will examine whether the implementation strategies differentially affect patient engagement, psychiatric symptom severity, and illness management capacity. The project addresses several NIMH strategic priorities and is highly innovative in its objectives, composition of the investigative team, data collection strategy, intervention and implementation models, and study design. The study adopts the NIMH experimental therapeutics approach and evaluates proposed mechanisms of action for both implementation and patient outcomes. At a micro-level, the study will help determine which strategies may facilitate, enhance, or hinder the uptake and clinical effects of FOCUS. At a macro-level, study findings will have broader implications for successful implementation of mHealth interventions in the years ahead. With multiple NIMH-funded mHealth and eHealth development and clinical trials currently underway, now is the opportune time to examine implementation strategies that will help pave the way for real-world uptake of the digital interventions that emerge as most promising.

Public Health Relevance

Poorly managed, schizophrenia spectrum disorders (SSD) lead to devastating patient outcomes and enormous societal costs. Mobile health (mHealth) interventions can bring much needed illness-management resources to this population, but how best to integrate digital health approaches in real-world community practice is unclear. This study aims to evaluate and compare two implementation approaches for an evidence- based mobile intervention and to produce findings that will pave the way for real-world implementation of mHealth in community mental health settings.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
Research Project (R01)
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Special Emphasis Panel (ZMH1)
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Azrin, Susan
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University of Washington
Schools of Medicine
United States
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