Substance AbuseNCT00057096
Onsite Versus Referral Models of Primary Care for Substance Abusing Patients
A study testing On-site vs. referral methods of care in people with Substance Abuse and Primary Medical Care, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse, Primary Medical Care
- What is being tested?
- On-site vs. referral methods of care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolling in addictions treatment, has no primary care provider currently and has some ongoing medical concern that would benefit from primary care.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
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.
Read the 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.
- Conditions
- Substance Abuse, Primary Medical Care
- Being tested
- On-site vs. referral methods of care
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-site vs. referral methods of careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Procedure: On-site vs. referral methods of care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2003 (estimated)
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Andrew J. Saxon, MD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057096
- Sponsor's protocol ID
- SUI 99-109
- Status last verified
- Feb 2007
- First submitted
- 27 Mar 2003
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16565634Davis 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.
PubMed 12127467Saxon 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.
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.
PubMed 15488340Zarkin 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.
PubMed 16223056Saxon 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.
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.
PubMed 18855809Buchholz 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.
PubMed 20592005
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onsite Versus Referral Models of Primary Care for Substance Abusing Patients
- ClinicalTrials.gov ID
- NCT00057096
- Acronym / sponsor ID
- SUI 99-109
- Conditions
- Substance Abuse, Primary Medical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Mar 2004 (actual)
- First posted
- 28 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: On-site vs. referral methods of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolling in addictions treatment, has no primary care provider currently and has some ongoing medical concern that would benefit from primary care.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-site vs. referral methods of care | Procedure or surgery | Arm 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 16565634Saxon 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 publication: PubMed 12127467Davis 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 publicationSaxon 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 publication: PubMed 15488340Calsyn 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 publication: PubMed 16223056Zarkin 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 publicationSaxon 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 publication: PubMed 18855809Caldeiro 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 publication: PubMed 20592005Buchholz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J. Saxon, MD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-site vs. referral methods of care in people with Substance Abuse and Primary Medical Care, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00057096, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.