Effectiveness of a Hospital Addiction Service in Treating Opioid and Alcohol Addiction (H-SOAP)
2014年12月10日 更新者：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.
研究概览
研究类型
介入性
注册 (预期的)
124
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5S 1B1
- 招聘中
- Women's College Hospital
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接触：
- Kahan
- 邮箱：meldon.kahan@wchospital.ca
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首席研究员：
- Meldon Kahan, MDCCFP FRCPC
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：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.).
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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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其他：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.
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment retention
大体时间：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
大体时间：36 months
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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
大体时间：36 months
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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
大体时间：12 months
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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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Meldon Kahan, MDCCFP FRCPC、Women's College Hospital
- 首席研究员：Anita Srivastava, MD MSc CCFP、St. Joseph's Health Centre
- 首席研究员：Rajesh Gupta, MD MEd FRCPC、Unity Health Toronto
- 首席研究员：Leslie Buckley, MD, MPH、University Health Network, Toronto
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年9月1日
初级完成 (预期的)
2015年4月1日
研究完成 (预期的)
2015年4月1日
研究注册日期
首次提交
2013年8月29日
首先提交符合 QC 标准的
2013年8月29日
首次发布 (估计)
2013年9月4日
研究记录更新
最后更新发布 (估计)
2014年12月11日
上次提交的符合 QC 标准的更新
2014年12月10日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.