Pain and Medication Use Following Surgery

NCT03179566 | Completed

• 2 other identifiers: HUM00129418MA-2017
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use

Keywords

drug disposal

Outcome Measures

Primary Outcomes (1)

• Drug disposal

  Patient-reported disposal of left-over opioid medications in any manner

  4 weeks post-surgery

Secondary Outcomes (1)

• Opioid disposal technique

  4 weeks post-surgery

Study Arms (3)

Usual Care

NO INTERVENTION

For the first two weeks, there will be no intervention or changes to the usual discharge instructions

Information Sheet

ACTIVE COMPARATOR

At discharge, patients will receive an informational sheet detailing options for safe drug disposal

Behavioral: Information Sheet

Deterra Drug Deactivation System

ACTIVE COMPARATOR

At discharge, patients will receive a Deterra Drug Deactivation System.

Behavioral: Information Sheet; Behavioral: Deterra Drug Deactivation System

Interventions

Information Sheet BEHAVIORAL

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.

Deterra Drug Deactivation System; Information Sheet

Deterra Drug Deactivation System BEHAVIORAL

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.

Deterra Drug Deactivation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for surgery at Michigan Medicine's East Ann Arbor Ambulatory Surgery \& Medical Procedures Center

You may not qualify if:

• Unable to speak English
• Inability to understand or complete the surveys
• Other conditions that preclude meaningful participation in the study

Sponsors & Collaborators

• University of Michigan: lead
• Michigan Department of Health and Human Services: collaborator

Study Sites (1)

East Ann Arbor Ambulatory Surgery & Medical Procedures Center - Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (13)

• 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.

  PMID: 26720857 BACKGROUND

• 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.

  PMID: 25896191 BACKGROUND

• 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.

  PMID: 27631771 BACKGROUND

• 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.

  PMID: 24868100 BACKGROUND

• 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.

  PMID: 27797283 BACKGROUND

• 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.

  PMID: 22204885 BACKGROUND

• 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.

  PMID: 24281287 BACKGROUND

• 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.

  PMID: 23298996 BACKGROUND

• 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.

  PMID: 25798880 BACKGROUND

• 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.

  PMID: 26679761 BACKGROUND

• 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.

  PMID: 16040201 BACKGROUND

• 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.

  PMID: 21115581 BACKGROUND

• 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.

  PMID: 21689917 BACKGROUND

Study Officials

• Chad Brummett, MD

  Michigan Medicine, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: A run-in period will precede the randomization sequence. Individuals will be randomized to one of two groups based on the day of their surgery.

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: June 6, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)