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An Integrated Model of Primary Care in Mental Health

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013260
First received: March 14, 2001
Last updated: August 1, 2012
Last verified: February 2007
  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.


Condition Intervention
Depression
Procedure: Integrated model of primary care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: An Integrated Model of Primary Care in Mental Health

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 271
Study Completion Date: July 2000
Arms Assigned Interventions
Arm 1 Procedure: Integrated model of primary care

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013260

Sponsors and Collaborators
Investigators
Principal Investigator: Morris Weinberger, PhD Durham VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013260     History of Changes
Other Study ID Numbers: MPC 97-010
Study First Received: March 14, 2001
Last Updated: August 1, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Case management
Nurse intervention

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 25, 2014