NCT00183313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

5 years

First QC Date

September 12, 2005

Last Update Submit

November 18, 2013

Conditions

Keywords

Mental HealthPrimary health careCase management

Outcome Measures

Primary Outcomes (1)

  • Quality of primary medical care

    Measured over 2 years

Secondary Outcomes (3)

  • Health status

    Measured over 2 years

  • Psychiatric symptoms

    2004-2009

  • Costs

    2004-2009

Study Arms (2)

1

EXPERIMENTAL

Participants will receive nurse case management intervention

Behavioral: Nurse case management

2

ACTIVE COMPARATOR

Participants will receive usual care

Behavioral: Usual care

Interventions

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.

1
Usual careBEHAVIORAL

Usual care includes standard mental health services.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Current use of medical case management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grady Health Systems

Atlanta, Georgia, 30303, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Benjamin G. Druss, MD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR
  • Silke A. von Esenwein, MA

    Emory University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

July 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations