Adapting the Bipolar Care Model for Chronic Care Management in Community-based Health Care Sites

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amy M. Kilbourne, University of Michigan
ClinicalTrials.gov Identifier:
NCT00747201
First received: September 4, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Bipolar Disorder
Behavioral: Replicating Effective Programs Framework for the Bipolar Care Model
Behavioral: Bipolar Care Model Package Only

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 Chronic Care Management for Bipolar Disorder

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 ]

Secondary Outcome Measures:
  • Cost-effectiveness [ Time Frame: Measured at 12-months ] [ Designated as safety issue: No ]

Enrollment: 384
Study Start Date: September 2009
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 Packaged intervention only
Patients will be seen by providers who receive the intervention package only.
Behavioral: Bipolar Care Model Package Only
Health care providers will receive only the adapted manuals.
Experimental: 1 Packaged intervention, training, and technical assistance
Patients will be seen by providers who receive the packaged intervention, along with provider training and ongoing technical assistance.
Behavioral: Replicating Effective Programs Framework for the Bipolar Care Model
Health care providers will receive adapted manuals, training, and technical assistance in the bipolar care model.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00747201

Locations
United States, Colorado
University of Colorado-Denver
Denver, Colorado, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Washtenaw Community Health Organization
Ann Arbor, Michigan, United States, 48108
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, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00747201     History of Changes
Other Study ID Numbers: R01 MH079994, R01MH079994, DSIR 82-SEDR
Study First Received: September 4, 2008
Last Updated: May 21, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Replicating Effective Programs
Care Management
Implementation
Intervention

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014