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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Procedure: Generalist Care Manager vs Usual Care


Participation Criteria
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Eligibility Criteria
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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 (

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Generalist Care Manager vs Usual Care|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Primary Care, Care Manager