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

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00373477
• Lead Sponsor: University of North Carolina

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.

Study Timeline

• Study Start: 2003-07
• Study Completion: 2005-02
• Status Verified: 2006-09
• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-06
• Last Update Submitted: 2006-09-06
• Study First Posted: 2006-09-08
• Last Update Posted: 2006-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hot Springs Health Program; 🇺🇸 Marshall, North Carolina, United States

Mountain Area Health Education Center (MAHEC); 🇺🇸 Asheville, North Carolina, United States