Viewing Study NCT00013260



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Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00013260
Status: COMPLETED
Last Update Posted: 2015-04-07
First Post: 2001-03-14

Brief Title: An Integrated Model of Primary Care in Mental Health
Sponsor: US Department of Veterans Affairs
Organization: VA Office of Research and Development

Study Overview

Official Title: An Integrated Model of Primary Care in Mental Health
Status: COMPLETED
Status Verified Date: 2007-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None