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

April 15, 2019 updated by: Amy M. Kilbourne, University of Michigan
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Experimental: 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.
Other Names:
  • Life Goals Collaborative Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-months
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.
12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amy M Kilbourne, PhD, MPH, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • R18HS021425-01A1 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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