Effectiveness of a Hospital Addiction Service in Treating Opioid and Alcohol Addiction (H-SOAP)
10. desember 2014 oppdatert av: Meldon Kahan, Women's College Hospital
Randomized Controlled Trial on the Effectiveness of Immediate Versus Delayed Access to Hospital-based Addiction Services
Hypothesis: Patients who are addicted to opioids or alcohol will have reduced substance use, health care utilization if they have immediate and convenient access to pharmacotherapy and addiction counselling.
Summary: This randomized trial will compare two different interventions for 124 alcohol and opioid-addicted patients admitted to either Women's Own Detox (WOD) at the University Health Network or the Withdrawal Management Service (WMS) at Saint Michael's Hospital (SMH. The Delayed Intervention group will receive a card with contact information for the St. Michael's Hospital and Women's College Hospital addiction medicine services. The Rapid Intervention group will be seen by an addiction physician from one of these services, within a day or two of their admission to the WOD or the SMH WMS. The addiction physician will prescribe buprenorphine or anti-alcohol medications, and the physician, nurse and/or therapist will provide ongoing counseling, follow-up and shared care with the family physician. Outcomes (measured at 6 and 12 months) include treatment retention, health care utilization and cost, medications prescribed, and alcohol and opioid use.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
124
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5S 1B1
- Rekruttering
- Women's College Hospital
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Ta kontakt med:
- Kahan
- E-post: meldon.kahan@wchospital.ca
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Hovedetterforsker:
- Meldon Kahan, MDCCFP FRCPC
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- a possible alcohol use disorder, as determined by a score of 8 or above on the AUDIT (Alcohol Use Disorders Identification Test); or, a possible opioid use disorder, as determined by positive responses on the eligibility form: within the past 30 days, opioid use has been a problem, and at least one harmful consequence of opioid use has been present, eg withdrawal symptoms, or problems with family, friends, work, money etc. If the addiction physician who assesses the patient at the first visit to the addiction service concludes that these screening tests were falsely positive and the patient does not have an alcohol or opioid use disorder, the physician will contact the RA to discharge the patient from the study.
- Interested in receiving treatment at an addiction medicine service.
- is alert and able to provide informed consent (ie is not confused, agitated, hostile, intoxicated, sedated or in severe withdrawal)
- Has attended a hospital Emergency Department or has been admitted to hospital in Ontario within the past year.
- Can speak and read English.
Exclusion Criteria:
- Pregnant
- Currently receiving methadone or buprenorphine treatment
- Cognitively impaired
- Unable to speak or read English
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: Opioid dependent
Subjects with a possible opioid use disorder, as determined by positive responses on the eligibility form: has used opioids within the past 30 days, opioid use has been a problem, and at least one harmful consequence of opioid use has been present (eg.
withdrawal symptoms, or problems with family, friends, work, money etc.).
|
Subjects randomized to the DI group will be given a card with the number for the usual Substance Use Service, where they will be seen within 2-4 weeks (standard practice).
If they attend the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.
Subjects randomized to the RI group will be seen in the Substance Use Service at within 1-2 days of study enrolment.
The Research Assistant will book the appointment and arrange transportation.
At the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.
|
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Annen: Alcohol dependent
Patients who indicate they have a problem with alcohol will be asked to complete the AUDIT, a validated, 10-item instrument that measures the severity of an alcohol problem.
The AUDIT enquires about core features of alcohol dependence, such as failure to fulfill obligations.
A score of 8 or more indicates possible alcohol dependence.
|
Subjects randomized to the DI group will be given a card with the number for the usual Substance Use Service, where they will be seen within 2-4 weeks (standard practice).
If they attend the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.
Subjects randomized to the RI group will be seen in the Substance Use Service at within 1-2 days of study enrolment.
The Research Assistant will book the appointment and arrange transportation.
At the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment retention
Tidsramme: 12 months
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The number of subjects in each group that attend the addiction service, and the mean number of visits per subject.
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12 months
|
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Healthcare utilization and cost
Tidsramme: 36 months
|
For each subject the ICES (Institute for Clinical Evaluative Sciences) linked administrative databases will be used to track, from 24 months before to 12 months after the initial visit: a) the number of hospitalizations and number of hospital days (Canadian Institute for Health Information (CIHI) Discharge Abstract Database), b) Emergency Department (ED) visits (CIHI National Ambulatory Care Reporting System), c) primary care visits and outpatient laboratory services (Ontario Health Information Plan Database).
During the monthly telephone calls and at the 6 and 12 month visits, the Research Assistant (RA) will ask subjects about recent ED visits, hospitalizations and outpatient medical visits
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36 months
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Prescriptions
Tidsramme: 36 months
|
For patients eligible for pharmacotherapy, ICES will be used to evaluate pre-post (prescribing from 24 months before study entry to 12 months after) changes in opioid and benzodiazepine prescribing, and prescribing of buprenorphine, methadone, and anti-alcohol drugs.
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36 months
|
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Substance use
Tidsramme: 12 months
|
The research assistant will conduct interviews at baseline, 6, and 12 months during which subjects will be asked about changes in substance use.
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Meldon Kahan, MDCCFP FRCPC, Women's College Hospital
- Hovedetterforsker: Anita Srivastava, MD MSc CCFP, St. Joseph's Health Centre
- Hovedetterforsker: Rajesh Gupta, MD MEd FRCPC, Unity Health Toronto
- Hovedetterforsker: Leslie Buckley, MD, MPH, University Health Network, Toronto
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- Soeffing JM, Martin LD, Fingerhood MI, Jasinski DR, Rastegar DA. Buprenorphine maintenance treatment in a primary care setting: outcomes at 1 year. J Subst Abuse Treat. 2009 Dec;37(4):426-30. doi: 10.1016/j.jsat.2009.05.003. Epub 2009 Jun 23.
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- Aszalos R, McDuff DR, Weintraub E, Montoya I, Schwartz R. Engaging hospitalized heroin-dependent patients into substance abuse treatment. J Subst Abuse Treat. 1999 Jul-Sep;17(1-2):149-58. doi: 10.1016/s0740-5472(98)00075-0.
- Shanahan CW, Beers D, Alford DP, Brigandi E, Samet JH. A transitional opioid program to engage hospitalized drug users. J Gen Intern Med. 2010 Aug;25(8):803-8. doi: 10.1007/s11606-010-1311-3. Epub 2010 Mar 17.
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- Mark TL, Montejano LB, Kranzler HR, Chalk M, Gastfriend DR. Comparison of healthcare utilization among patients treated with alcoholism medications. Am J Manag Care. 2010;16(12):879-88.
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- Kahan M, Borgundvaag B, Midmer D, Borsoi D, Edwards C, Ladhani N. Treatment variability and outcome differences in the emergency department management of alcohol withdrawal. CJEM. 2005 Mar;7(2):87-92. doi: 10.1017/s1481803500013038.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Forventet)
1. april 2015
Studiet fullført (Forventet)
1. april 2015
Datoer for studieregistrering
Først innsendt
29. august 2013
Først innsendt som oppfylte QC-kriteriene
29. august 2013
Først lagt ut (Anslag)
4. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BRIDGES
- MOHLTC (Annen identifikator: University of Toronto, Ontario Ministry of Health)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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