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Not yet recruiting NCT07549178

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

No phase Interventional Severe Mental Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Care Coordination Mobile.
Who it may be relevant to
Registry conditions: Severe Mental Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Detailed 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

Interventions

  • Behavioral Care Coordination Mobile
    Mobile monitoring, peer coaching, and enhanced care coordination

Primary outcome measures

  • Acute care utilization [Time frame: 9 months]
Secondary outcome measures (7)
  • Interpersonal supports - Interpersonal Support Evaluation List (ISEL) [Time frame: 9 months]
  • Patient activation - Patient Activation Measure (PAM) [Time frame: 9 months]
  • Engagement with care - Working Alliance Inventory (WAI) [Time frame: 9 months]
  • Receipt of care appropriate for chronic conditions - Patient Assessment of Chronic Illness Care (PACIC) [Time frame: 9 months]
  • Care experience - Ambulatory Care Experiences Survey (ACES) [Time frame: 9 months]
  • Psychiatric symptoms - Behavior And Symptom Identification Scale (BASIS-24) [Time frame: 9 months]
  • Quality of life - Veterans RAND 12 item Health Survey (VR-12) [Time frame: 9 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 2 centers
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia

Identifiers

NCT: NCT07549178 · HSR4-022-24W

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗