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Disseminating Evidence-based Mood Disorder Chronic Care Models

Primary Purpose

Bipolar Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic Care Model for Mood Disorders
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, Implementation, Intervention, Mood Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Currently being seen as a patient at the participating site
  • Active diagnosis or treatment plan for Bipolar Disorder (I, II, NOS) or unipolar depression.

Exclusion Criteria:

  • No active substance intoxication
  • No acute medical illness or dementia
  • No active suicidal ideation at time of participation

Sites / Locations

  • Stanford University
  • University of California- San Francisco
  • University of Colorado- Denver
  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Usual Care

Arm Description

Patients will receive their usual care from providers at the clinic.

Outcomes

Primary Outcome Measures

Quality of Life
Decreased Mood Disorder Symptoms

Secondary Outcome Measures

Full Information

First Posted
June 6, 2012
Last Updated
June 8, 2012
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01615458
Brief Title
Disseminating Evidence-based Mood Disorder Chronic Care Models
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

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 can improve patient health.
Detailed Description
Chronic mood disorders (notably, bipolar disorder and recurrent unipolar major depressive disorder) are associated with substantial functional impairment, morbidity, economic burden, and mortality. Depression and bipolar disorder are common and are the leading causes of disability worldwide, are associated with substantial costs, and when left untreated, can lead to premature mortality, particularly from suicide. Despite the proliferation of evidence-based guidelines for the treatment of mood disorders, the quality of care and subsequent outcomes remain suboptimal for those suffering from these illnesses. Collaborative chronic care models (CCMs) have demonstrated efficacy and cost-effectiveness in managing depression and more recently, bipolar disorder. Many of the successful interventions to improve depression treatment and outcomes (e.g., PROSPECT) are based on the Chronic Care Model (CCM). These treatment models combine patient self-management education with ongoing care coordination that is delivered by a care manager, who coordinates care with primary care and mental health providers and facilitates systematic dissemination of guidelines related to mood disorders treatment. In bipolar disorder, CCMs have been found to be cost-neutral, and in depression, cost-effective compared to usual care; hence making business cases for CCMs is promising in both the private and public sectors. There is mounting demand for CCMs to be implemented for patients across different mental health diagnoses, in order to maximize their reach across diverse clinic populations, and to make them more appealing to healthcare providers, who might be reluctant to hire multiple care managers for different conditions. Unipolar major depressive and bipolar disorders are some of the most common forms of mood disorders treated in specialty mental health as well as in primary care settings. Up to 5.5% and 16.2% of the population have bipolar spectrum disorder and unipolar major depressive disorder, respectively. Based on pilot data from Colorado Access, about a third of patents being treated for depression in routine care settings screened positive for bipolar disorder. Moreover, only a third of patients with unipolar depression remit, which in part might be attributed to under-treatment or inappropriate treatment of bipolar II disorder. However, while CCMs for unipolar depression and bipolar disorder exist, to date they have not been implemented in combination. This project will pilot test a combined CCM that can be applied to patients with unipolar depression or bipolar disorder in specialty mental health or primary care clinics. This is a one-year pilot randomized controlled trial comparing LGCC to usual care that will involve patients diagnosed with bipolar disorder or unipolar depression who are receiving care in clinics affiliated with NNDC sites or unaffiliated primary care sites. The project will be implemented in three phases: training of existing staff at the local Depression Center clinics, implementation of LGCC, and final outcomes evaluation to inform future studies. Patients from up to four mental health clinics affiliated with NNDC sites (University of Michigan Depression Center, Stanford University Depression Center, University of Colorado-Denver Depression Center, and University of California-San Francisco Depression Center) and 1 primary care setting (Packard Community Health, Ann Arbor, MI) will be randomized to receive LGCC or standard care as usual (32 per site; total 160 patients). Randomization will be stratified by diagnosis (unipolar depression or bipolar disorder). At the end of the pilot study, patients not randomized to receive LGCC will be offered the intervention. An additional 10 providers will be asked to complete surveys from their site (total n=50), for a grand total of n=210 participants (160 patients and 50 providers).

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, Implementation, Intervention, 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
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Patients will receive their usual care from providers at the clinic.
Intervention Type
Behavioral
Intervention Name(s)
Chronic Care Model for Mood Disorders
Other Intervention Name(s)
Life Goals Collaborative Care
Intervention Description
CCM includes (1) patient self-management enhancement focused on promoting healthy lifestyles as coping strategies to minimize the negative impact of depressive, manic, and other affective symptoms; (2) provider support for evidence-based decision-making; and (3) enhanced access and continuity for anticipatory rather than reactive care.
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
Change in From Baseline in Quality of Life at 6-months.
Title
Decreased Mood Disorder Symptoms
Time Frame
Change from Baseline in Mood Disorder Symptoms at 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently being seen as a patient at the participating site Active diagnosis or treatment plan for Bipolar Disorder (I, II, NOS) or unipolar depression. Exclusion Criteria: No active substance intoxication No acute medical illness or dementia No active suicidal ideation at time of participation
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
Country
United States
Facility Name
University of California- San Francisco
City
San Francisco
State/Province
California
Country
United States
Facility Name
University of Colorado- Denver
City
Denver
State/Province
Colorado
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Disseminating Evidence-based Mood Disorder Chronic Care Models

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