The purpose of this research study is to learn whether or not a coordinated medical and psychiatric care program can improve quality and outcomes of care for patients with bipolar disorder. We hypothesize that coordinated care via a Care Manager will improve patient adherence, quality of general medical care, symptoms, and overall functioning.

Condition	Intervention
Bipolar Disorder	Behavior: Disease Management

Further Study Details: 

Primary Outcomes: Adherence; Quality of care
Secondary Outcomes: Functioning; Quality of life; Symptoms
Expected Total Enrollment:  80

Bipolar disorder is a chronic illness associated with significant personal and societal costs. Patients with bipolar disorder also experience more general medical comorbidities than the general population. Potential disparities exist in the receipt of medical and preventive care for individuals with serious mental illness compared to those without serious mental illness. The goal of this study is to pilot test an adapted version of the Wagner Chronic Care Model (CCM) to improve the continuity and quality of general medical and psychiatric care for veterans with bipolar disorder. Our target population will be all patients >=25 years of age with a diagnosis of bipolar disorder (bipolar I, II, NOS) receiving care in the VA Pittsburgh Healthcare System. We plan on consenting and enrolling 80 patients, in which 40 will be randomized to receive the intervention, and 40 will receive enhanced usual care. Key components of the intervention include: 1) access to a Care Manager who will help patients make and keep appointments for general medical care by contacting patients on a regular basis; 2) a self-management program, which is education on adherence and self-management for patients by the Care Manager, including information on side-effects, bipolar disorder illness, and tips on communicating with general medical providers that will be provided during 7 group sessions during the first 3 months of the study, and; 3) a registry that tracks patient progress maintained by the Care Manager. Both groups will receive practice guidelines for the treatment of medical conditions tailored to the needs of patients with bipolar disorder. Patients in the intervention arm will meet with the Care Manager after the baseline assessment, who will initially set up regular visits or contacts with the patients and work with them to connect with a primary care clinician. A Survey Coordinator will have patients complete a baseline assessment, and then a follow up assessment at 3, 6, and 12 months later. Key outcomes include: 1) adequate processes of care for general medical conditions, notably adequate preventive care and adequate cardiovascular risk factor evaluation; 2) adequate processes of care for bipolar disorder, including adequate monitoring of mood stabilizer concentrations and toxicity for bipolar disorder medications; 3) treatment adherence; and4) bipolar disorder-specific symptoms. Findings from this study will inform our long-term goal of implementing a larger scale version of the adapted CCM for veterans with bipolar disorder.

Ages Eligible for Study:  25 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1) >=25 years old, 2) active diagnosis of bipolar disorder, 3) have an assigned primary care provider in the VA Pittsburgh, and 4) have been seen by a provider in the Beta Team Mood Disorders clinic.

Exclusion Criteria:

1) actively using substances (alcohol or drugs) at the time of enrollment, 2) already enrolled in a mental health program with a mobile outreach component in which clinical caregivers deliver services to the patient in the community (e.g., Assertive Community Treatment or Intensive Case Management), 3) have a terminal medical illness with <3 years expected longevity, or 4) unable to provide informed consent for this study. (Ineligibility to be confirmed based on registry review and Survey Coordinator’s assessment)

Please refer to this study by ClinicalTrials.gov identifier  NCT00222755

Amy M Kilbourne, PhD      412-688-6477    Amy.Kilbourne@med.va.gov
Patrick Elder      412-688-6477    Patrick.Elder@med.va.gov

Pennsylvania
      VA Pittsburgh Healthcare System, Pittsburgh,  Pennsylvania,  15240,  United States

Study chairs or principal investigators

Amy M Kilbourne, PhD,  Principal Investigator,  University of Pittsburgh   

Study ID Numbers:  02394
Last Updated:  September 21, 2005
Record first received:  September 19, 2005
ClinicalTrials.gov Identifier:  NCT00222755
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27