Improving Primary Care in Patients With Mental Disorders

NCT ID: NCT00183313

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2009-07-31

Brief Summary

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This study will determine the effectiveness of medical case management in improving the medical care of people with mental disorders or substance abuse problems.

Detailed Description

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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.

Conditions

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Mental Disorders

Keywords

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Mental Health Primary health care Case management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Participants will receive nurse case management intervention

Group Type EXPERIMENTAL

Nurse case management

Intervention Type BEHAVIORAL

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

Participants will receive usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Usual care includes standard mental health services.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual care

Usual care includes standard mental health services.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Current use of medical case management
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Druss

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin G. Druss, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Silke A. von Esenwein, MA

Role: STUDY_DIRECTOR

Emory University

Locations

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Grady Health Systems

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Druss BG, von Esenwein SA, Compton MT, Rask KJ, Zhao L, Parker RM. A randomized trial of medical care management for community mental health settings: the Primary Care Access, Referral, and Evaluation (PCARE) study. Am J Psychiatry. 2010 Feb;167(2):151-9. doi: 10.1176/appi.ajp.2009.09050691. Epub 2009 Dec 15.

Reference Type DERIVED
PMID: 20008945 (View on PubMed)

Other Identifiers

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R01MH070437

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 82-SEPC

Identifier Type: -

Identifier Source: secondary_id

IRB00002164

Identifier Type: -

Identifier Source: org_study_id