- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00057096
Onsite Versus Referral Models of Primary Care for Substance Abusing Patients
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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:
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Arm 1
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Andrew J. Saxon, MD, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SUI 99-109
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