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

Primary Purpose

Bipolar Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic Care Model for Mood Disorders
Educational Control
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bipolar Disorder focused on measuring Care Management, Chronic Care Model, Mood Disorders

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Educational Control

Chronic Care Model for Mood Disorders

Arm Description

Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.

Life Goals Collaborative Care

Outcomes

Primary Outcome Measures

Health-related Quality of Life, as Measured by the Mental Health Component Score
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.
Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)
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.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2014
Last Updated
April 15, 2019
Sponsor
University of Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT02041962
Brief Title
Implementing Health Plan-Level Care Management for Solo & Small Practices
Official Title
Implementing Health Plan-Level Care Management for Solo & Small Practices
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Depression
Keywords
Care Management, Chronic Care Model, Mood Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational Control
Arm Type
Active Comparator
Arm Description
Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.
Arm Title
Chronic Care Model for Mood Disorders
Arm Type
Experimental
Arm Description
Life Goals Collaborative Care
Intervention Type
Behavioral
Intervention Name(s)
Chronic Care Model for Mood Disorders
Other Intervention Name(s)
Life Goals Collaborative Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Control
Primary Outcome Measure Information:
Title
Health-related Quality of Life, as Measured by the Mental Health Component Score
Description
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.
Time Frame
12-months
Title
Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)
Description
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.
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M Kilbourne, PhD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30602344
Citation
Kilbourne AM, Prenovost KM, Liebrecht C, Eisenberg D, Kim HM, Un H, Bauer MS. Randomized Controlled Trial of a Collaborative Care Intervention for Mood Disorders by a National Commercial Health Plan. Psychiatr Serv. 2019 Mar 1;70(3):219-224. doi: 10.1176/appi.ps.201800336. Epub 2019 Jan 3.
Results Reference
derived
PubMed Identifier
25520807
Citation
Kilbourne AM, Nord KM, Kyle J, Van Poppelen C, Goodrich DE, Kim HM, Eisenberg D, Un H, Bauer MS. Randomized controlled trial of a health plan-level mood disorders psychosocial intervention for solo or small practices. BMC Psychol. 2014 Nov 13;2(1):48. doi: 10.1186/s40359-014-0048-x. eCollection 2014.
Results Reference
derived

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

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