Back to resultsA Study of the Cost Effectiveness of Generalist Care Managers for Depression Treatment in Medicaid Recipients
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Generalist Care Manager vs Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Primary Care, Care Manager
Eligibility 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 (
Sites / Locations
- Mountain Area Health Education Center (MAHEC)
- Hot Springs Health Program
Outcomes
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
Full Information
NCT ID
NCT00373477
First Posted
September 6, 2006
Last Updated
September 6, 2006
Sponsor
University of North Carolina
Collaborators
Robert Wood Johnson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00373477
Brief Title
A Study of the Cost Effectiveness of Generalist Care Managers for Depression Treatment in Medicaid Recipients
Official Title
A Randomized Trial of the Cost Effectiveness of Generalist Care Managers for the Treatment of Depression in Medicaid Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina
Collaborators
Robert Wood Johnson Foundation
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Primary Care, Care Manager
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Generalist Care Manager vs Usual Care
Primary Outcome Measure Information:
Title
Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 (
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Landis, MD, MPH
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mountain Area Health Education Center (MAHEC)
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28804
Country
United States
Facility Name
Hot Springs Health Program
City
Marshall
State/Province
North Carolina
ZIP/Postal Code
28753
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Cost Effectiveness of Generalist Care Managers for Depression Treatment in Medicaid Recipients
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