Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Improving Primary Care in Patients With Mental Disorders

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Benjamin Druss, Emory University
ClinicalTrials.gov Identifier:
NCT00183313
First received: September 12, 2005
Last updated: November 18, 2013
Last verified: November 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Emory University:

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
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.

  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
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, see Learn About Clinical Studies.

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
Emory University
Investigators
Principal Investigator: Benjamin G. Druss, MD, MPH Emory University
Study Director: Silke A. von Esenwein, MA Emory University
  More Information

No publications provided by Emory University

Additional 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, DSIR 82-SEPC
Study First Received: September 12, 2005
Last Updated: November 18, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 24, 2014