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| Tracking Information | |||||||||
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| First Received Date † | September 12, 2005 | ||||||||
| Last Updated Date | February 13, 2008 | ||||||||
| Start Date † | July 2004 | ||||||||
| Current Primary Outcome Measures † |
Quality of primary medical care [ Time Frame: Measured over 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00183313 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
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| Original Secondary Outcome Measures † |
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| Descriptive Information | |||||||||
| Brief Title † | Improving Primary Care in Patients With Mental Disorders | ||||||||
| Official Title † | Improving Primary Care in Patients With Mental Disorders | ||||||||
| Brief Summary | This study will determine the effectiveness of medical case management in improving the medical care of people with mental disorders or substance abuse problems. |
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| 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. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition † | Mental Disorders | ||||||||
| Intervention † |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 407 | ||||||||
| Estimated Completion Date | July 2009 | ||||||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00183313 | ||||||||
| Responsible Party | Benjamin G. Druss, MD MPH, Emory University | ||||||||
| Secondary IDs †† | DSIR 82-SEPC | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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