- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00183313
Improving Primary Care in Patients With Mental Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Poor quality of care may contribute to impaired health status and increased mortality in individuals with serious mental disorders and substance abuse problems; interventions designed to improve medical care for this population need to be developed. This study will develop a population-based medical case management model for improving the primary medical care of patients at an inner city community mental health center.
This study will last 2 years. Participants will be randomly assigned to receive medical case management or standard of care (typically drug and behavioral therapy) for 2 years. Participants in the case management group will receive help in overcoming barriers to receiving primary care. Participants will also undergo 5 interviews over the 2-year study duration, and have annual chart reviews. Results of the interviews will be used to assess quality of primary care, service use, health outcomes, psychiatric symptoms, and substance use.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Atlanta, Georgia, United States, 30303
- Grady Health Systems
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of mental illness or substance abuse
- Patient at Florida Hall (Grady Health Systems)
Exclusion Criteria:
- Current use of medical case management
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Participants will receive usual care
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Usual care includes standard mental health services.
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Experimental: 1
Participants will receive nurse case management intervention
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Nurse case management is a population-based medical case management program to improve the delivery of primary medical care to patients with serious mental illness in a Community Mental Health Center (CMHC) in Atlanta GA.
The treatment draws on elements from the primary care, nursing case management, chronic disease, health behavior change literature, and from the study team's experience in integrating primary care services for patients with serious mental illnesses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of primary medical care
Time Frame: Measured over 2 years
|
Measured over 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health status
Time Frame: Measured over 2 years
|
Measured over 2 years
|
Psychiatric symptoms
Time Frame: 2004-2009
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2004-2009
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Costs
Time Frame: 2004-2009
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2004-2009
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Benjamin G. Druss, MD, MPH, Emory University
- Study Director: Silke A. von Esenwein, MA, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00002164
- DSIR 82-SEPC
- R01MH070437 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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