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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amy M. Kilbourne, University of Michigan
ClinicalTrials.gov Identifier:
NCT02041962
First received: January 3, 2014
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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 Intervention
Bipolar Disorder
Depression
Behavioral: Chronic Care Model for Mood Disorders
Other: Educational Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Implementing Health Plan-Level Care Management for Solo & Small Practices

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Change from Baseline in Quality of Life at 12-months ] [ Designated as safety issue: No ]
  • Reduced Mood Disorder Symptoms [ Time Frame: Change from Baseline in Mood Disorder Symptoms at 12-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved Guideline-Concordant Care [ Time Frame: Change from Baseline in Guideline-Concordant Care at 12-months ] [ Designated as safety issue: No ]
    guideline-concordant care (e.g., mood disorders treatment, cardiometabolic monitoring)

  • Reduced Hospitalizations [ Time Frame: Change from Baseline in Number of Hospitalizations at 12-months. ] [ Designated as safety issue: No ]
  • Improved Work Productivity [ Time Frame: Change from Baseline in Work Productivity at 12-months ] [ Designated as safety issue: No ]

Estimated Enrollment: 344
Study Start Date: July 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041962

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Amy M Kilbourne, PhD, MPH University of Michigan
  More Information

No publications provided

Responsible Party: Amy M. Kilbourne, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02041962     History of Changes
Other Study ID Numbers: R18 HS 21425-01A1
Study First Received: January 3, 2014
Last Updated: October 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Care Management
Chronic Care Model
Mood Disorders

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 29, 2014