Clinical trial NCT00013260: An Integrated Model of Primary Care in Mental Health
Official title: An Integrated Model of Primary Care in Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Case management
Nurse intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 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:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: North Carolina
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Morris Weinberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: