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

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ClinicalTrials.gov Identifier: NCT00747201
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amy M. Kilbourne, University of Michigan

Tracking Information
First Submitted Date  ICMJE September 4, 2008
First Posted Date  ICMJE September 5, 2008
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
Quality of Life [ Time Frame: Change from Baseline in Quality of Life at 12-months. ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
  • Patient clinical outcomes, including functioning, quality of life, and symptoms [ Time Frame: Measured at baseline and after 3, 6, and 12 months ]
  • Patient adherence to the bipolar care model [ Time Frame: Measured at baseline and after 3, 6, and 12 months ]
Change History Complete list of historical versions of study NCT00747201 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
Cost-effectiveness [ Time Frame: Measured at 12-months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
Cost-effectiveness [ Time Frame: Measured at baseline and after 3, 6, and 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adapting the Bipolar Care Model for Chronic Care Management in Community-based Health Care Sites
Official Title  ICMJE Implementing Chronic Care Management for Bipolar Disorder
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • 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.
  • Behavioral: Bipolar Care Model Package Only
    Health care providers will receive only the adapted manuals.
Study Arms  ICMJE
  • Active Comparator: 2 Packaged intervention only
    Patients will be seen by providers who receive the intervention package only.
    Intervention: Behavioral: Bipolar Care Model Package Only
  • 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.
    Intervention: Behavioral: Replicating Effective Programs Framework for the Bipolar Care Model
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2014)
384
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2008)
520
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747201
Other Study ID Numbers  ICMJE R01MH079994( U.S. NIH Grant/Contract )
R01MH079994 ( U.S. NIH Grant/Contract )
DSIR 82-SEDR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amy M. Kilbourne, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Amy M. Kilbourne, PhD, MPH University of Michigan
PRS Account University of Michigan
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP