- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03179566
Pain and Medication Use Following Surgery (SODAS)
Safe Opioid Disposal After Surgery Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- East Ann Arbor Ambulatory Surgery & Medical Procedures Center - Michigan Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: Usual Care
For the first two weeks, there will be no intervention or changes to the usual discharge instructions
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Comparador Ativo: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Drug disposal
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Opioid disposal technique
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chad Brummett, MD, Michigan Medicine, Department of Anesthesiology
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- HUM00129418
- MA-2017 (Número de outro subsídio/financiamento: Michigan Department of Health and Human Services)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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