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

September 6, 2006 updated by: University of North Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Asheville, North Carolina, United States, 28804
        • Mountain Area Health Education Center (MAHEC)
      • Marshall, North Carolina, United States, 28753
        • Hot Springs Health Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina

Collaborators

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Suzanne Landis, MD, MPH, University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

September 6, 2006

First Submitted That Met QC Criteria

September 6, 2006

First Posted (Estimate)

September 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 8, 2006

Last Update Submitted That Met QC Criteria

September 6, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-fam/med-161
  • RWJF ID number: 048128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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