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

Sponsor

University of North Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT00373477

Collaborator

Robert Wood Johnson Foundation (Other)

300

Enrollment

Locations

19.1

Duration (Months)

150

Patients Per Site

7.9

Patients Per Site Per Month

Study Details

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	Phase
Major Depressive Disorder	Procedure: Generalist Care Manager vs Usual Care	N/A

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

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 :

Jul 1, 2003

Study Completion Date :

Feb 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mountain Area Health Education Center (MAHEC)	Asheville	North Carolina	United States	28804
2	Hot Springs Health Program	Marshall	North Carolina	United States	28753