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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02041962
Recruitment Status : Completed
First Posted : January 22, 2014
Results First Posted : April 16, 2019
Last Update Posted : April 23, 2019
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Amy M. Kilbourne, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Depression Behavioral: Chronic Care Model for Mood Disorders Other: Educational Control Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Implementing Health Plan-Level Care Management for Solo & Small Practices
Study Start Date : July 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders

Arm Intervention/treatment
Active Comparator: Educational Control
Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.
Other: Educational Control
Experimental: Chronic Care Model for Mood Disorders
Life Goals Collaborative Care
Behavioral: Chronic Care Model for Mood Disorders
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.
Other Name: Life Goals Collaborative Care

Primary Outcome Measures :
  1. Health-related Quality of Life, as Measured by the Mental Health Component Score [ Time Frame: 12-months ]
    Mental Health Quality of Life was measured using the 12-item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.

  2. Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question) [ Time Frame: 12-months ]
    Mood disorder symptoms were measured using the Patient Health Questionnaire (9-question). The PHQ-9 has a scale range of 0-27 with lower values representing better outcomes.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02041962

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Agency for Healthcare Research and Quality (AHRQ)
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Principal Investigator: Amy M Kilbourne, PhD, MPH University of Michigan
  Study Documents (Full-Text)

Documents provided by Amy M. Kilbourne, University of Michigan:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Amy M. Kilbourne, Professor, University of Michigan Identifier: NCT02041962    
Other Study ID Numbers: R18HS021425-01A1 ( U.S. AHRQ Grant/Contract )
First Posted: January 22, 2014    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: April 23, 2019
Last Verified: April 2019
Keywords provided by Amy M. Kilbourne, University of Michigan:
Care Management
Chronic Care Model
Mood Disorders
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders