Expired Study
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Indianapolis, North Carolina 46202


Purpose:

Managed care systems rely on primary care providers as gatekeepers to make sensible decisions regarding the use of expensive health care resources. While this model has some intuitive appeal in terms of its potential for decreasing health care costs, it may not be applicable in VA medical centers, where patients are often medically complex and socioeconomically vulnerable. Thus, other strategies to integrate generalist and specialist care are required.


Study summary:

Background: Managed care systems rely on primary care providers as gatekeepers to make sensible decisions regarding the use of expensive health care resources. While this model has some intuitive appeal in terms of its potential for decreasing health care costs, it may not be applicable in VA medical centers, where patients are often medically complex and socioeconomically vulnerable. Thus, other strategies to integrate generalist and specialist care are required. Objectives: Our objective is to evaluate the effectiveness of an integrated model of primary care for veterans with alcohol dependence and/or depression in which mental health clinical nurse specialists (CNS) are placed within the General Medicine Clinic (GMC). Our primary outcomes are patients� disease-specific mental health symptoms (Beck Depression Inventory: BDI) and satisfaction with care (RAND). Secondary outcomes include quality of care, health services utilization, and health care costs. Methods: This is a randomized, controlled trial comparing patients in two GMC firms. After physicians in both firms were trained in the diagnosis and brief treatment of the two conditions, the two firms were randomized into one of two conditions. Patients in both firms are screened for depression. Patients who screen positive for depression and give written informed consent are enrolled. In the control firm, depression screening results are provided to the primary care physician. In the integrated primary care firm, results are shared with the primary care provider, along with having a mental health clinical nurse specialist in the GMC who is available to implement and support treatment decisions. Telephone interviews are conducted at three and 12 months after enrollment to collect outcome data by persons blinded to the study hypotheses. Data will also be collected using local VA databases. Data analysis will utilize generalized estimating equations to account for the repeated measures design, clustering of patients within physicians, and clustering of physicians within clinics. Status: Data collection was completed during August, 2000. Data analyses for the one-year follow-up results are in process.


Criteria:

Inclusion Criteria: - diagnosis of depression (ie, major depression, dysthymia, or partially remitted major depression); - received primary care from the General Medicine Clinic; and 3) access to a telephone. Patients were excluded if they were: 1) incompetent for interview (eg, active psychosis, dementia documented in medical chart); 2) residents of a nursing home; - actively suicidal (ie, stated plans/means and/or had suicide attempt during past two years); - seen in a VA mental health program (made a visit during the previous 30 days and had a future appointment scheduled); - active cocaine or opiate abusers; - history of bipolar disorder; or - terminally ill (ie, death expected with 12 months) using criteria successfully employed in previous studies of veterans in primary care Exclusion Criteria:


Study is Available At:


Original ID:

MPC 97-010


NCT ID:

NCT00013260


Secondary ID:


Study Acronym:


Brief Title:

An Integrated Model of Primary Care in Mental Health


Official Title:

An Integrated Model of Primary Care in Mental Health


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

271


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Morris Weinberger, PhD
Principal Investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Dates

Completion Date:July 2000
Completion Type:Actual
Verification Date:February 2007
Last Changed Date:April 6, 2015
First Received Date:March 14, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Procedure
Name:Integrated model of primary care
Arm Name:Arm 1

Study Arms

Study Arm Type:Other
Arm Name:Arm 1

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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