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Improving Primary Care in Patients With Mental Disorders

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 16, 2005
Last Update Posted: November 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Benjamin Druss, Emory University
This study will determine the effectiveness of medical case management in improving the medical care of people with mental disorders or substance abuse problems.

Condition Intervention Phase
Mental Disorders Behavioral: Nurse case management Behavioral: Usual care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Primary Care in Patients With Mental Disorders

Resource links provided by NLM:

Further study details as provided by Benjamin Druss, Emory University:

Primary Outcome Measures:
  • Quality of primary medical care [ Time Frame: Measured over 2 years ]

Secondary Outcome Measures:
  • Health status [ Time Frame: Measured over 2 years ]
  • Psychiatric symptoms [ Time Frame: 2004-2009 ]
  • Costs [ Time Frame: 2004-2009 ]

Enrollment: 407
Study Start Date: July 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive nurse case management intervention
Behavioral: Nurse case management
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.
Active Comparator: 2
Participants will receive usual care
Behavioral: Usual care
Usual care includes standard mental health services.

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of mental illness or substance abuse
  • Patient at Florida Hall (Grady Health Systems)

Exclusion Criteria:

  • Current use of medical case management
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183313

United States, Georgia
Grady Health Systems
Atlanta, Georgia, United States, 30303
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Principal Investigator: Benjamin G. Druss, MD, MPH Emory University
Study Director: Silke A. von Esenwein, MA Emory University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benjamin Druss, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00183313     History of Changes
Other Study ID Numbers: IRB00002164
R01MH070437 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Benjamin Druss, Emory University:
Mental Health
Primary health care
Case management

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders