This trial is active, not recruiting.

Conditions bipolar disorder, depression
Treatments chronic care model for mood disorders, educational control
Sponsor University of Michigan
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date July 2014
End date August 2018
Trial size 280 participants
Trial identifier NCT02041962, R18HS021425-01A1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
(Active Comparator)
Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.
educational control
Life Goals Collaborative Care
chronic care model for mood disorders Life Goals Collaborative Care
The mood disorders CCM intervention ("Life Goals Collaborative Care") consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session.

Primary Outcomes

Quality of Life
time frame: Change from Baseline in Quality of Life at 12-months
Reduced Mood Disorder Symptoms
time frame: Change from Baseline in Mood Disorder Symptoms at 12-months

Secondary Outcomes

Improved Guideline-Concordant Care
time frame: Change from Baseline in Guideline-Concordant Care at 12-months
Reduced Hospitalizations
time frame: Change from Baseline in Number of Hospitalizations at 12-months.
Improved Work Productivity
time frame: Change from Baseline in Work Productivity at 12-months

Eligibility Criteria

Male or female participants from 21 years up to 99 years old.

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

Additional Information

Official title Implementing Health Plan-Level Care Management for Solo & Small Practices
Principal investigator Amy M Kilbourne, PhD, MPH
Description A 2010 HHS report highlighted the prevalence, morbidity, and cost associated with clusters of co-occurring chronic conditions, both physical and mental. The report also underscored the lack of sustainable treatment strategies for these afflicted individuals, and the difficulties in customizing patient-centered interventions. Collaborative chronic care models (CCMs) are effective in treating chronic medical and mental illnesses at little to no net healthcare cost. To date CCMs have primarily been implemented at the facility level and primarily developed for and adopted by larger healthcare organizations. However, we have determined that the vast majority of primary care and behavioral health practices providing commercially insured care are far too small to implement such models. Health plan-level CCMs can address this unmet need. Chronic mood disorders (e.g., bipolar disorders, depression) are common and are associated with extensive functional impairment, medical comorbidity, and personal and societal costs. While unipolar depression is more common, bipolar disorder is more costly on a per patient basis due to its chronic and severe nature. Moreover, bipolar disorder is the most expensive mental disorder for U.S. commercial health plans and employers. While evidence-based care parameters have been well established for mood disorders, quality of care and health outcomes in general mental health practice are suboptimal. The majority of these patients suffer from clusters of comorbid conditions, both physical and mental. Thus mood disorders represent optimal tracer conditions with which to improve management strategies for individuals with multiple chronic conditions. Accordingly, we have partnered with Aetna Inc. to develop and implement a CCM designed to improve outcomes for persons with mood disorders for solo or small practices, with an eye towards developing a business case for a generalizable plan-level CCM for chronic disorders. We will conduct an RCT of a health plan-level CCM vs. education control. The population of interest will be Aetna beneficiaries across the country hospitalized for depression or bipolar disorder treated in solo or small primary care or behavioral health practices. Patients will be randomized to one year of outpatient treatment augmented by the CCM or education control, for a total of 344 participants. Practices participation in the study will be limited to completion of an organizational survey. We anticipate 172 practices to complete these surveys. CCM care management will be fully remote from practice venues and patients, implemented by existing providers (the Aetna care management center). A business case will be developed using the Replicating Effective Programs (REP) strategy that identifies generalizable facilitators for CCM spread and value added of CCMs to be vetted to key industry and policy stakeholders.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Michigan.