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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00373477
Enrollment
300
Registered
2006-09-08
Start date
2003-07-31
Completion date
2005-02-28
Last updated
2006-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Depression, Primary Care, Care Manager

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.

Interventions

PROCEDUREGeneralist Care Manager vs Usual Care

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
University of North Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 (

Design outcomes

Primary

MeasureTime frame
Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores

Secondary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026