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

NCT ID: NCT00373477

Last Updated: 2006-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-02-28

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.

Conditions

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Major Depressive Disorder

Keywords

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Depression Primary Care Care Manager

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Generalist Care Manager vs Usual Care

Intervention Type PROCEDURE

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 (
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role lead

Principal Investigators

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Suzanne Landis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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Mountain Area Health Education Center (MAHEC)

Asheville, North Carolina, United States

Site Status

Hot Springs Health Program

Marshall, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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RWJF ID number: 048128

Identifier Type: -

Identifier Source: secondary_id

03-fam/med-161

Identifier Type: -

Identifier Source: org_study_id