Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care (CCM)

VA Office of Research and Development

Status: Enrolling

Conditions: Severe Mental Illness

Treatments: Behavioral: Care Coordination Mobile

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07549178

HSR4-022-24W

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

CCM

Active Comparator group

Description:

Mobile monitoring, peer coaching, and enhanced care coordination

Treatment:

Behavioral: Care Coordination Mobile

usual care

No Intervention group

Description:

Usual care services