Improving Primary Care in Patients With Mental Disorders - Full Text View

Purpose

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 III

MedlinePlus related topics:

Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Improving Primary Care in Patients With Mental Disorders

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Quality of primary medical care [ Time Frame: Measured over 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Health status [ Time Frame: Measured over 2 years ] [ Designated as safety issue: No ]
Psychiatric symptoms [ Time Frame: 2004-2009 ] [ Designated as safety issue: No ]
Costs [ Time Frame: 2004-2009 ] [ Designated as safety issue: No ]

Enrollment:	407
Study Start Date:	July 2004
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183313

Locations


United States, Georgia
	Emory University
	Atlanta, Georgia, United States, 30322
	Grady Health Systems
	Atlanta, Georgia, United States, 30303

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Benjamin G. Druss, MD, MPH	Emory University

Study Director:	Silke A. von Esenwein, MA	Emory University

More Information

Responsible Party:	Emory University ( Benjamin G. Druss, MD MPH )
Study ID Numbers:	R01 MH70437, DSIR 82-SEPC
First Received:	September 12, 2005
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00183313
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Mental Health

Primary health care

Case management

Study placed in the following topic categories:

Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183313