Pain and Medication Use Following Surgery (SODAS)
2017年9月8日 更新者：Chad Brummett、University of Michigan
Safe Opioid Disposal After Surgery Trial
Patients will be randomized to one of two interventions intended to facilitate safe disposal of opioids after cessation following surgery.
For pragmatic reasons, participants will be randomized by day to either the information sheet or the disposal bag using a block randomization schedule.
To ensuring adequate sample size, patients will be enrolled for a ~4-week period following the 2-week usual care run in period.
In the event that the sample size estimate has not been reached after the 4-week intervention period, additional patients will be enrolled accordingly.
研究概览
详细说明
The lack of evidence-based guidelines for postoperative opioid prescribing has contributed to a surplus of opioid pills within our patients' homes and communities, increasing the potential for diversion and nonmedical use. A recent study suggests that for outpatient general surgery procedures, roughly 72% of prescribed opioids go unused. Current opioid disposal options are limited to DEA-authorized opioid collectors, including select law enforcement agencies, pharmacies, or organized pill drop events, and many patients remain unaware of these avenues. Several studies have found that few patients have knowledge about opioid disposal options and even fewer dispose of their unconsumed opioids.
Unconsumed opioids pose a diversion risk. In the 2011 National Survey on Drug Use and Health, 70.8% of those who used a prescription medication non-medically obtained the medication from a friend or relative, with or without their knowledge. Additionally, nonmedical prescription opioid use is a common pathway to heroin use. Importantly, over 80% of young intravenous drug users report initiation of prescription opioid misuse prior to heroin.
Considering that 40% of the prescriptions written by surgeons are for opioids and patients frequently have excess opioids and limited options for and/or knowledge of opioid disposal, the present study will provide patients with information and novel options for opioid disposal as part of the surgical care pathway.
研究类型
介入性
注册 (实际的)
391
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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Michigan
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Ann Arbor、Michigan、美国、48109
- East Ann Arbor Ambulatory Surgery & Medical Procedures Center - Michigan Medicine
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Scheduled for surgery at Michigan Medicine's East Ann Arbor Ambulatory Surgery & Medical Procedures Center
Exclusion Criteria:
- Unable to speak English
- Inability to understand or complete the surveys
- Other conditions that preclude meaningful participation in the study
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：其他
- 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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无干预：Usual Care
For the first two weeks, there will be no intervention or changes to the usual discharge instructions
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有源比较器：Information Sheet
At discharge, patients will receive an informational sheet detailing options for safe drug disposal
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Patients will receive an informational sheet about how to dispose of leftover opioid medication during discharge.
Nurses will provide this information sheet and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.
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有源比较器：Deterra Drug Deactivation System
At discharge, patients will receive a Deterra Drug Deactivation System.
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Patients will receive an informational sheet about how to dispose of leftover opioid medication during discharge.
Nurses will provide this information sheet and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.
This system is a pouch that deactivates prescription drugs, rendering them ineffective for misuse and safe for regular garbage disposal.
It uses a patented activated carbon technology to deactivate drugs, including pills, liquids, and patches, and has been found to be 99% percent effective in studies funded by the National Institute of Drug Abuse (NIDA).
Additionally, the pouches are made from environmentally friendly materials and contain active ingredients that are considered non-toxic and pose minimal risk, according to their MSDS.
Nurses will provide the Deterra bag and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.
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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 |
|---|---|---|
|
Drug disposal
大体时间：4 weeks post-surgery
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Patient-reported disposal of left-over opioid medications in any manner
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4 weeks post-surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Opioid disposal technique
大体时间：4 weeks post-surgery
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Patient-reported technique for disposal of left-over opioid medications specifically assessing for safe disposal using recommended disposal methods
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4 weeks post-surgery
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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：Chad Brummett, MD、Michigan Medicine, Department of Anesthesiology
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
- Lewis ET, Cucciare MA, Trafton JA. What do patients do with unused opioid medications? Clin J Pain. 2014 Aug;30(8):654-62. doi: 10.1097/01.ajp.0000435447.96642.f4.
- Levy B, Paulozzi L, Mack KA, Jones CM. Trends in Opioid Analgesic-Prescribing Rates by Specialty, U.S., 2007-2012. Am J Prev Med. 2015 Sep;49(3):409-13. doi: 10.1016/j.amepre.2015.02.020. Epub 2015 Apr 18.
- Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
- Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3.
- Lankenau SE, Teti M, Silva K, Jackson Bloom J, Harocopos A, Treese M. Initiation into prescription opioid misuse amongst young injection drug users. Int J Drug Policy. 2012 Jan;23(1):37-44. doi: 10.1016/j.drugpo.2011.05.014. Epub 2011 Jun 20.
- Reddy A, de la Cruz M, Rodriguez EM, Thames J, Wu J, Chisholm G, Liu D, Frisbee-Hume S, Yennurajalingam S, Hui D, Cantu H, Marin A, Gayle V, Shinn N, Xu A, Williams J, Bruera E. Patterns of storage, use, and disposal of opioids among cancer outpatients. Oncologist. 2014 Jul;19(7):780-5. doi: 10.1634/theoncologist.2014-0071. Epub 2014 May 27.
- Egan KL, Gregory E, Sparks M, Wolfson M. From dispensed to disposed: evaluating the effectiveness of disposal programs through a comparison with prescription drug monitoring program data. Am J Drug Alcohol Abuse. 2017 Jan;43(1):69-77. doi: 10.1080/00952990.2016.1240801. Epub 2016 Oct 31.
- Tanabe P, Paice JA, Stancati J, Fleming M. How do emergency department patients store and dispose of opioids after discharge? A pilot study. J Emerg Nurs. 2012 May;38(3):273-9. doi: 10.1016/j.jen.2011.09.023. Epub 2011 Dec 26.
- McCabe SE, West BT, Boyd CJ. Leftover prescription opioids and nonmedical use among high school seniors: a multi-cohort national study. J Adolesc Health. 2013 Apr;52(4):480-5. doi: 10.1016/j.jadohealth.2012.08.007. Epub 2012 Nov 22.
- Voepel-Lewis T, Wagner D, Tait AR. Leftover prescription opioids after minor procedures: an unwitting source for accidental overdose in children. JAMA Pediatr. 2015 May;169(5):497-8. doi: 10.1001/jamapediatrics.2014.3583. No abstract available.
- Vaughn MG, Nelson EJ, Salas-Wright CP, Qian Z, Schootman M. Racial and ethnic trends and correlates of non-medical use of prescription opioids among adolescents in the United States 2004-2013. J Psychiatr Res. 2016 Feb;73:17-24. doi: 10.1016/j.jpsychires.2015.11.003. Epub 2015 Nov 11.
- Boyd CJ, Esteban McCabe S, Teter CJ. Medical and nonmedical use of prescription pain medication by youth in a Detroit-area public school district. Drug Alcohol Depend. 2006 Jan 4;81(1):37-45. doi: 10.1016/j.drugalcdep.2005.05.017. Epub 2005 Jul 22.
- Fortuna RJ, Robbins BW, Caiola E, Joynt M, Halterman JS. Prescribing of controlled medications to adolescents and young adults in the United States. Pediatrics. 2010 Dec;126(6):1108-16. doi: 10.1542/peds.2010-0791. Epub 2010 Nov 29.
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 (实际的)
2017年6月6日
初级完成 (实际的)
2017年9月1日
研究完成 (实际的)
2017年9月1日
研究注册日期
首次提交
2017年6月5日
首先提交符合 QC 标准的
2017年6月5日
首次发布 (实际的)
2017年6月7日
研究记录更新
最后更新发布 (实际的)
2017年9月11日
上次提交的符合 QC 标准的更新
2017年9月8日
最后验证
2017年9月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- HUM00129418
- MA-2017 (其他赠款/资助编号：Michigan Department of Health and Human Services)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Information Sheet的临床试验
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Yan JinXijing Hospital; Tang-Du Hospital未知
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University Hospital, LilleMinistry of Health, France完全的