Onsite Versus Referral Models of Primary Care for Substance Abusing Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00057096
First received: March 27, 2003
Last updated: October 25, 2013
Last verified: February 2007
  Purpose

Veterans presenting for treatment of substance use disorders (SUDs) often have multiple and serious comorbid medical conditions that affect functional health status and health care costs. Prior studies show higher rates of medical follow-up when onsite primary health care was provided to patients with SUDs within an addictions clinic (onsite care). However, no data are available on differences between onsite versus referral models of primary care delivery in terms of clinical outcomes and total health care costs.


Condition Intervention
Substance Abuse
Primary Medical Care
Procedure: On-site vs. referral methods of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Onsite Versus Referral Models of Primary Care for Substance Abusing Patients

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 800
Study Completion Date: March 2004
Arms Assigned Interventions
Arm 1 Procedure: On-site vs. referral methods of care

Detailed Description:

Background:

Veterans presenting for treatment of substance use disorders (SUDs) often have multiple and serious comorbid medical conditions that affect functional health status and health care costs. Prior studies show higher rates of medical follow-up when onsite primary health care was provided to patients with SUDs within an addictions clinic (onsite care). However, no data are available on differences between onsite versus referral models of primary care delivery in terms of clinical outcomes and total health care costs.

Objectives:

The objectives of this study are to compare patients with SUDs who receive onsite primary care in a VA outpatient addictions clinic to those referred for primary care to the general internal medicine clinic on: 1) medical outcomes and quality of life; 2) SUD treatment outcomes; and 3) overall health care costs. This information will assist in identifying practice guidelines for providing preventive services and treatment for acute and chronic medical conditions to individuals in SUD treatment.

Methods:

This study is a randomized clinical trial with two treatment conditions: 1) onsite primary care in the Addictions Treatment Center (ATC; experimental); or 2) referral primary care in the General Internal Medicine Clinic (GIMC; control). Subjects are assessed at baseline and at 3, 6, and 12-month time points. The sample includes 720 veterans, newly presenting or returning to SUD treatment, who exhibited a chronic medical condition at screening, did not have a primary care provider; and did not present with a serious medical condition requiring ongoing care in three or more organ systems. Medical status outcome measures include scores on the SF-36, and total emergency room visits and medical or surgical inpatient admissions. Substance abuse outcomes are measured by treatment retention, changes in Addiction Severity Index (ASI) scores, and self-reported alcohol use. Lastly, overall VA health care costs per subject per the 12-month period following randomization are compared across groups. The main analysis involves intent-to-treat analysis of group (onsite vs. referral) by time (3, 6, 12-month) using random effects regression models.

Status:

Complete. All subjects completed study interventions as of 3/31/2004. Currently data analysis is ongoing.

  Eligibility

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

Inclusion Criteria:

Enrolling in addictions treatment, has no primary care provider currently and has some ongoing medical concern that would benefit from 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: NCT00057096

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Investigators
Principal Investigator: Andrew J. Saxon, MD VA Puget Sound Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00057096     History of Changes
Other Study ID Numbers: SUI 99-109
Study First Received: March 27, 2003
Last Updated: October 25, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 16, 2014