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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373477
• Other study ID #: 03-fam/med-161
• Secondary ID: RWJF ID number:
• Status: Completed
• Phase: N/A
• First received: September 6, 2006
• Last updated: September 6, 2006
• Start date: July 2003
• Est. completion date: February 2005

Study information

• Verified date: September 2006
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Procedure:
• Generalist Care Manager vs Usual Care

Locations

Country	Name	City	State
United States	Mountain Area Health Education Center (MAHEC)	Asheville	North Carolina
United States	Hot Springs Health Program	Marshall	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores
Secondary	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