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

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00373477
First received: September 6, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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 Intervention
Major Depressive Disorder
Procedure: Generalist Care Manager vs Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: July 2003
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373477

Locations
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
Investigators
Principal Investigator: Suzanne Landis, MD, MPH University of North Carolina
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00373477     History of Changes
Other Study ID Numbers: 03-fam/med-161, RWJF ID number: 048128
Study First Received: September 6, 2006
Last Updated: September 6, 2006
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014