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An Integrated Model of Primary Care in Mental Health
This study has been completed.
Study NCT00013260   Information provided by Department of Veterans Affairs
First Received: March 14, 2001   Last Updated: October 31, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

March 14, 2001
October 31, 2008
 
 
 
Complete list of historical versions of study NCT00013260 on ClinicalTrials.gov Archive Site
 
 
 
An Integrated Model of Primary Care in Mental Health
An Integrated Model of Primary Care in Mental Health

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.

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.

 
Interventional
Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Depression
Procedure: Integrated model of primary care
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
271
July 2000
 

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:

Both
18 Years and older
No
 
United States
 
 
NCT00013260
Weinberger, Morris - Principal Investigator, Department of Veterans Affairs
 
Department of Veterans Affairs
 
Principal Investigator: Morris Weinberger, PhD Durham VA Medical Center
Department of Veterans Affairs
March 2001

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.