N/A N=238 Randomized Single-blind Health Services Research

Implementing Health Plan-Level Care Management for Solo & Small Practices

Bipolar Disorder · Depression

Bottom Line

View on ClinicalTrials.gov: NCT02041962 ↗

Enrolled (actual)

238

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Health-related Quality of Life, as Measured by the Mental Health Component Score — 38.2; 43.2 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Chronic Care Model for Mood Disorders (Behavioral); Educational Control (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Health-related Quality of Life, as Measured by the Mental Health Component Score	38.2; 43.2	—
PRIMARY Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)	9.3; 7.6	—

Summary

This study will determine if a version of the chronic care model for individuals with mood disorders seen in small or solo practices can improve patient health.

Eligibility Criteria

Inclusion Criteria

Currently covered by Aetna's HMO or preferred provider products (for whom Aetna provides mental and medical inpatient, outpatient, and pharmacy benefits) for at least 6 months
Recent (past 6-month) hospitalization for an acute psychiatric or partial hospital unit with a manic or depressive episode and confirmation of mood disorder diagnosis in the medical record (presence of one inpatient or two outpatient ICD-9 codes: 296.1x-296.8x in previous 6 months)
Ability to speak and read English and provide informed consent
Current principal outpatient prescribing provider is a solo practitioner or in a practice with <=3 providers.

Exclusion Criteria

No active substance intoxication
No acute medical illness or dementia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02041962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.