Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057096
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2003-03-27
Brief Title:
Onsite Versus Referral Models of Primary Care for Substance Abusing Patients
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Onsite Versus Referral Models of Primary Care for Substance Abusing Patients
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3312004 Currently data analysis is ongoing
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 3312004 Currently data analysis is ongoing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None