Adapting the Bipolar Care Model for Chronic Care Management in Community-based Health Care Sites
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Replicating Effective Programs Framework for the Bipolar Care Model
Bipolar Care Model Package Only
Sponsored by
About this trial
This is an interventional health services research trial for Bipolar Disorder focused on measuring Replicating Effective Programs, Care Management, Implementation, Intervention
Eligibility Criteria
Inclusion Criteria:
- Currently being seen as a patient at the participating site
- Active diagnosis or treatment plan for Bipolar I, Bipolar II, or Bipolar not otherwise specified (NOS)
Exclusion Criteria:
- Serious illness that would prevent participation in the BCM components as indicated by the provider
- Living in a nursing home or other institution
Sites / Locations
- University of Colorado-Denver
- Washtenaw Community Health Organization
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2 Packaged intervention only
1 Packaged intervention, training, and technical assistance
Arm Description
Patients will be seen by providers who receive the intervention package only.
Patients will be seen by providers who receive the packaged intervention, along with provider training and ongoing technical assistance.
Outcomes
Primary Outcome Measures
Quality of Life
Secondary Outcome Measures
Cost-effectiveness
Full Information
NCT ID
NCT00747201
First Posted
September 4, 2008
Last Updated
May 21, 2014
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00747201
Brief Title
Adapting the Bipolar Care Model for Chronic Care Management in Community-based Health Care Sites
Official Title
Implementing Chronic Care Management for Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine if a version of the bipolar care model adapted for a nonresearch audience can improve patient health and correct use of the model in community-based mental health care sites.
Detailed Description
For the approximately 5.7 million Americans suffering from bipolar disorder, recurring manic and depressive symptoms, psychosis, and a high suicide risk prevent normal functioning and normal interpersonal relationships. Bipolar disorder has a high economic cost, as well, both because care for those with the disorder is expensive and because those suffering from the disorder have difficulty holding jobs. The total cost of bipolar disorder in the United States is estimated to be $45 billion. Part of this economic cost comes from poor quality of care. Only half of bipolar patients receive adequate outpatient care, and only a third receive adequate drug levels and safety monitoring. This can lead to preventable hospitalizations, emergency room use, and deaths.
Often, new results from research can take years or decades to be translated into practice in community mental health care. Even then, new methods can be less effective in practice because there is inadequate understanding of or technical support for these methods. This occurs because research is not presented in enough detail or with enough flexibility to be adapted for community settings.
The Centers for Disease Control and Prevention's (CDC's) Replicating Effective Programs (REP) project is a systematic method of replicating effective behavioral interventions for reducing HIV risk. The REP has three components:
Packaging, or adapting, a behavioral treatment so its scientific protocols are in nontechnical, user-friendly language
Providing formal training for health care professionals in implementing the package
Supporting the use of the package through technical assistance available to individual treatment sites
The REP framework has been effective in extending the availability of HIV behavioral interventions and ensuring proper implementation, but it has never been used for non-HIV-related interventions, nor has it been proven that wider availability of these new interventions improves patient health and quality of life. This study will examine both of these untested areas of the REP framework by packaging a new intervention for bipolar disorder, called the Bipolar Care Model (BCM). Research shows the BCM to be effective in real-world settings and across different ethnic groups. This study will determine if a packaged version of the BCM will be effective across multiple, community-based, mental health settings. Success with the packaged version of the BCM will not only make this particular treatment more available to mental health care providers, but it will create a model for transitioning all research on new behavioral interventions for mental health into effective practice.
This study will last 2 years from its first implementation to the final collection of patient data at the participating mental health care sites. The care sites that will participate in this study will be randomly assigned to receive either the BCM package, training, and technical assistance or the BCM package alone. Adherence to the BCM model and patient outcomes at each care site will be measured at baseline and after 6, 12, and 24 months. Also at these intervals, patients at each care site will be contacted for a 30-minute survey on their treatment. Care sites will be assessed on the following: adherence to the BCM model, as assessed through site records; patient clinical outcomes, as assessed through questionnaires on bipolar symptoms, functioning, and quality of life; and costs, as assessed through records of training hours, technical assistance hours, and hours spent by REP implementers. The total cost of developing the intervention according to the REP framework will also be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Replicating Effective Programs, Care Management, Implementation, Intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
384 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 Packaged intervention only
Arm Type
Active Comparator
Arm Description
Patients will be seen by providers who receive the intervention package only.
Arm Title
1 Packaged intervention, training, and technical assistance
Arm Type
Experimental
Arm Description
Patients will be seen by providers who receive the packaged intervention, along with provider training and ongoing technical assistance.
Intervention Type
Behavioral
Intervention Name(s)
Replicating Effective Programs Framework for the Bipolar Care Model
Intervention Description
Health care providers will receive adapted manuals, training, and technical assistance in the bipolar care model.
Intervention Type
Behavioral
Intervention Name(s)
Bipolar Care Model Package Only
Intervention Description
Health care providers will receive only the adapted manuals.
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
Change from Baseline in Quality of Life at 12-months.
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Time Frame
Measured at 12-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 I, Bipolar II, or Bipolar not otherwise specified (NOS)
Exclusion Criteria:
Serious illness that would prevent participation in the BCM components as indicated by the provider
Living in a nursing home or other institution
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 Colorado-Denver
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Washtenaw Community Health Organization
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
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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Adapting the Bipolar Care Model for Chronic Care Management in Community-based Health Care Sites
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