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A Study of the Cost Effectiveness of Generalist Care Managers for Depression Treatment in Medicaid Recipients

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ClinicalTrials.gov Identifier: NCT00373477
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : September 8, 2006
Information provided by:

Study Description
Brief Summary:
This project will enable the investigators to conduct a randomized clinical trial to demonstrate the value of generalist care managers in the treatment of depression in Medicaid patients seen in primary health care practices. Depressed patients will be recruited at two primary care practices in Western North Carolina and randomly assigned to either generalist care management or usual care. Patients in each condition will be assessed at baseline and six months follow-up. Outcomes will include depressive symptoms, level of functioning, and cost-effectiveness measures.

Condition or disease Intervention/treatment
Major Depressive Disorder Procedure: Generalist Care Manager vs Usual Care

Detailed Description:
Randomized trial among depressed Medicaid patients aged 18 years and older in 2 primary care practices in Western NC comparing an intervention with a GCM to usual care (UC) between July 2003 and February 2005. GCMs, already providing diabetes and asthma services, were further trained and given ongoing supervision to provide algorithm–based depression care to enhance guideline concordant treatment. GCMs provided elements of self-management, decision support, use of information systems, and core care management components.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Cost Effectiveness of Generalist Care Managers for the Treatment of Depression in Medicaid Recipients
Study Start Date : July 2003
Estimated Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores

Secondary Outcome Measures :
  1. Baseline and 6-month Short Form (SF)-12 scores, Medicaid claims data; patient perception of treatment by self-report; review of GCM case notes, physician and office staff time study; physician and office staff focus groups

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • scoring 10 or greater on PHQ-9 and primary care physician verification of major depression by clinical exam; and
  • willing to begin or continue antidepressant medication

Exclusion Criteria:

  • bipolar disorder, psychotic symptoms, or active suicidal ideation requiring psychiatric admission (
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373477

United States, North Carolina
Mountain Area Health Education Center (MAHEC)
Asheville, North Carolina, United States, 28804
Hot Springs Health Program
Marshall, North Carolina, United States, 28753
Sponsors and Collaborators
University of North Carolina
Robert Wood Johnson Foundation
Principal Investigator: Suzanne Landis, MD, MPH University of North Carolina
More Information

ClinicalTrials.gov Identifier: NCT00373477     History of Changes
Other Study ID Numbers: 03-fam/med-161
RWJF ID number: 048128
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2006

Keywords provided by University of North Carolina, Chapel Hill:
Primary Care
Care Manager

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders