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Onsite Versus Referral Models of Primary Care for Substance Abusing Patients

Primary Purpose

Substance Abuse, Primary Medical Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
On-site vs. referral methods of care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 27, 2003
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00057096
Brief Title
Onsite Versus Referral Models of Primary Care for Substance Abusing Patients
Official Title
Onsite Versus Referral Models of Primary Care for Substance Abusing Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Primary Medical Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
On-site vs. referral methods of care

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J. Saxon, MD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16565634
Citation
Saxon AJ, Malte CA, Sloan KL, Baer JS, Calsyn DA, Nichol P, Chapko MK, Kivlahan DR. Randomized trial of onsite versus referral primary medical care for veterans in addictions treatment. Med Care. 2006 Apr;44(4):334-42. doi: 10.1097/01.mlr.0000204052.95507.5c.
Results Reference
result
PubMed Identifier
12127467
Citation
Davis TM, Carpenter KM, Malte CA, Carney M, Chambers S, Saxon AJ. Women in addictions treatment: comparing VA and community samples. J Subst Abuse Treat. 2002 Jul;23(1):41-8. doi: 10.1016/s0740-5472(02)00242-8.
Results Reference
result
Citation
Saxon A, Sloan K, Nichol P, Howell D, Bush K, Calsyn D, Baer J, Felker B, Kivlahan D. Substance Dependent Individuals Often Lack Awareness of Their Medical Conditions. Drug and Alcohol Dependence. 2002 Oct 15; 66:S156-S156.
Results Reference
result
PubMed Identifier
15488340
Citation
Calsyn DA, Saxon AJ, Bush KR, Howell DN, Baer JS, Sloan KL, Malte CA, Kivlahan DR. The Addiction Severity Index medical and psychiatric composite scores measure similar domains as the SF-36 in substance-dependent veterans: concurrent and discriminant validity. Drug Alcohol Depend. 2004 Nov 11;76(2):165-71. doi: 10.1016/j.drugalcdep.2004.04.018.
Results Reference
result
PubMed Identifier
16223056
Citation
Zarkin GA, Bray JW, Mitra D, Cisler RA, Kivlahan DR. Cost methodology of COMBINE. J Stud Alcohol Suppl. 2005 Jul;(15):50-5; discussion 33. doi: 10.15288/jsas.2005.s15.50.
Results Reference
result
Citation
Saxon A, Calsyn D, Sloan K, Baer J, Kivlahan D, Felker B, Nichol P, Paden G, DeMarco F. Primary care attendance of substance dependent patients. Drug and Alcohol Dependence. 2001 Jun 1; 63:S1.
Results Reference
result
PubMed Identifier
18855809
Citation
Caldeiro RM, Malte CA, Calsyn DA, Baer JS, Nichol P, Kivlahan DR, Saxon AJ. The association of persistent pain with out-patient addiction treatment outcomes and service utilization. Addiction. 2008 Dec;103(12):1996-2005. doi: 10.1111/j.1360-0443.2008.02358.x. Epub 2008 Oct 8.
Results Reference
result
PubMed Identifier
20592005
Citation
Buchholz JR, Malte CA, Calsyn DA, Baer JS, Nichol P, Kivlahan DR, Caldeiro RM, Saxon AJ. Associations of housing status with substance abuse treatment and service use outcomes among veterans. Psychiatr Serv. 2010 Jul;61(7):698-706. doi: 10.1176/ps.2010.61.7.698.
Results Reference
result

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Onsite Versus Referral Models of Primary Care for Substance Abusing Patients

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