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Not yet recruiting Not applicable NCT07549178

Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care

No applicable phase (e.g. observational)
Conditions: Severe Mental Illness

Sponsor: VA Office of Research and Development

trial.available_in: БГ
Overview
Providing care to individuals with serious mental illness can be challenging, requiring ongoing monitoring, treatment adjustments, and coordination of various medical and social services. Rates of emergency service and hospital use are high due to unexpected social, medical, and mental health crises. Stressors and poor adherence with treatment are common and can lead to rapid worsening in symptoms, job loss, homelessness, incarceration, or suicide. Clinician visits can be infrequent. Patient-clinician contact between visits is challenging and often nonexistent. As such, illness exacerbations usually occur with no clinician awareness in real time, leaving limited opportunity to provide services. Clinicians need interventions that are capable of monitoring and quickly detecting worsening behaviors and illness, to improve care coordination, outreach, and treatment. This project studies the effectiveness of enhanced care coordination using passive mobile data monitoring and support from peer specialists, with the goal of improving outcomes and reducing the need for acute care.
Description
Overview: Providing care to individuals with serious mental illness (SMI) can be challenging, requiring ongoing monitoring, treatment adjustments, and coordination of various medical and social services. Rates of emergency service and hospital use are high due to unexpected social, medical, and mental health crises. A variety of stressors and poor adherence with treatment are common and can lead to rapid worsening in symptoms, job loss, homelessness, incarceration, or suicide. Clinician visits can be infrequent. Patient-clinician contact between visits is challenging and often nonexistent. As such, illness exacerbations usually occur with no clinician awareness in real time, leaving limited opportunity to provide services. This project studies, in Veterans with SMI and high risk for acute care, the effectiveness of an enhanced care coordination mobile intervention (CCM) that uses passive mobile data and support from peer coaches. The investigators hypothesize that CCM will reduce the need for acute care services in comparison to usual care. Specific Aims: Among Veterans with SMI: 1. Engage Veterans and clinicians in co-design activities that adapt previously tested protocols and tools to guide implementation of enhanced care coordination with mobile (CCM intervention) that includes passive mobile monitoring of Veterans' mental health status, technology and behavioral supports from peer coaches, and care coordination within a Behavioral Health Interdisciplinary Program (BHIP). 2. Determine the effectiveness of CCM on acute care use. Implement CCM using protocols and tools from Aim 1 and randomize high-risk patients with SMI to CCM or usual care for 9 months. 3. Evaluate implementation of CCM. 4. Conduct a budget impact analysis of CCM. Methodology: Population: patients with SMI and high risk for acute care use. Intervention: enhanced care coordination within a VA BHIP program using passive mobile monitoring and supports from peer coaches Comparison: effectiveness trial with randomization to CCM or usual care for 9 months Outcome: reduction in use of urgent care services (emergency visits, hospitalization, or death) Qualitative and quantitative methods
Who can participate
Inclusion Criteria: * a medical record diagnosis of Serious Mental Illness (SMI) * defined as schizophrenia, schizoaffective disorder, or bipolar disorder * receipt of care at the VA site during the prior 9 months * a Care Assessment Need (CAN) score over the 75th percentile, indicating high risk for hospitalization or death in the upcoming year * ownership of a smart phone Exclusion Criteria: * none
Interventions
Care Coordination Mobile
BEHAVIORAL
Locations 2
United States (2)
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia , Pennsylvania
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles , California
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.08.2026
Completion date
30.04.2030
Registry ID
NCT07549178
Source
clinicaltrials.gov
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