Improving Primary Care in Patients With Mental Disorders

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. Identifier: NCT00183313
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : November 19, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Benjamin Druss, Emory University

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.

Condition or disease Intervention/treatment Phase
Mental Disorders Behavioral: Nurse case management Behavioral: Usual care Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
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
Study Start Date : July 2004
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Benjamin Druss, Principal Investigator, Emory University Identifier: NCT00183313     History of Changes
Other Study ID Numbers: IRB00002164
R01MH070437 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
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