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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

none

Trial design

Design model

Parallel

Treatments tested in this trial

  • Care Coordination Mobile

    Behavioral

    Mobile monitoring, peer coaching, and enhanced care coordination

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: CCMActive comparator 1 intervention
Group B: usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Acute care utilization

Use of emergency service, use of hospitals, and death are each a binary measure (yes/no). These will be combined to make one binary measure that is yes if any one of these three is yes, and otherwise no.

Time frame
9 months

Secondary outcomes

1

Interpersonal supports - Interpersonal Support Evaluation List (ISEL)

Level of social support measured using the Interpersonal Support Evaluation List-12 (ISEL). Scores can range from 0 to 36, with higher scores indicating a better outcome.

Time frame
9 months
2

Patient activation - Patient Activation Measure (PAM)

Patient activation measured using the short-form Patient Activation Measure (PAM-13). Scores can range from 13 to 52, with higher scores indicating a better outcome.

Time frame
9 months
3

Engagement with care - Working Alliance Inventory (WAI)

Engagement with care measured using the Working Alliance Inventory for General Practice (WAI-GP). Scores can range from 12 to 60, with higher scores indicating a better outcome.

Time frame
9 months
4

Receipt of care appropriate for chronic conditions - Patient Assessment of Chronic Illness Care (PACIC)

Receipt of care appropriate for chronic conditions measured using the 20-item Patient Assessment of Chronic Illness Care (PACIC). Scores can range from 20 to 100, with higher scores indicating a better outcome.

Time frame
9 months

Other outcomes

Sponsors and contacts

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