Improving Primary Care in Patients With Mental Disorders

Mental Disorders Clinical Trial

Official title:

Improving Primary Care in Patients With Mental Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183313
• Other study ID #: IRB00002164
• Secondary ID: R01MH070437DSIR
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 18, 2013
• Start date: July 2004
• Est. completion date: July 2009

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of mental illness or substance abuse

• Patient at Florida Hall (Grady Health Systems)

Exclusion Criteria:

• Current use of medical case management

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

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.
• Usual care
Usual care includes standard mental health services.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Grady Health Systems	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of primary medical care		Measured over 2 years	No
Secondary	Health status		Measured over 2 years	No
Secondary	Psychiatric symptoms		2004-2009	No
Secondary	Costs		2004-2009	No