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Improving Primary Care in Patients With Mental Disorders

Primary Purpose

Mental Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nurse case management
Usual care
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorders focused on measuring Mental Health, Primary health care, Case management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of mental illness or substance abuse Patient at Florida Hall (Grady Health Systems) Exclusion Criteria: Current use of medical case management

Sites / Locations

  • Grady Health Systems
  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive nurse case management intervention

Participants will receive usual care

Outcomes

Primary Outcome Measures

Quality of primary medical care

Secondary Outcome Measures

Health status
Psychiatric symptoms
Costs

Full Information

First Posted
September 12, 2005
Last Updated
November 18, 2013
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00183313
Brief Title
Improving Primary Care in Patients With Mental Disorders
Official Title
Improving Primary Care in Patients With Mental Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Mental Health, Primary health care, Case management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive nurse case management intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Nurse case management
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
Usual care includes standard mental health services.
Primary Outcome Measure Information:
Title
Quality of primary medical care
Time Frame
Measured over 2 years
Secondary Outcome Measure Information:
Title
Health status
Time Frame
Measured over 2 years
Title
Psychiatric symptoms
Time Frame
2004-2009
Title
Costs
Time Frame
2004-2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin G. Druss, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silke A. von Esenwein, MA
Organizational Affiliation
Emory University
Official's Role
Study Director
Facility Information:
Facility Name
Grady Health Systems
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20008945
Citation
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.
Results Reference
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Improving Primary Care in Patients With Mental Disorders

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