Distribution of Medication Disposal Packets - Acute Opioid Prescribing

NCT05169281 | Completed

• 1 other identifier: 827461_1
• Study Type: interventional
• Target: 657
• Locations: 1 country
• Sites: 1

Brief Summary

Many prescription opioids following surgery are left unused and are at risk of being misused or diverted. Encouraging proper disposal is important, yet motivating this behavior remains challenging as patients must understand the risks of opioids, the benefits of disposal, and identify opportunities and places to dispose of them safely. Alternative disposal techniques can improve disposal rates but may be lost or forgotten. Applying behavioral economics techniques may lower the barriers and promote disposal. The objective is to test the effect of a specifically timed, mailed, at-home kit on disposal rates following surgery.

Conditions

Orthopedic Surgery; Neurosurgery; Surgery; Opioid Use; Opioid Misuse

Keywords

Opioid Prescribing; Mobile Health; Quality Improvement; Learning Health Systems

Outcome Measures

Primary Outcomes (1)

• Self-Reported Opioid Disposal

  The opioid disposal kits provided patients with a timely, easy, and safe disposal technique which was sent to them between post-operative day 4-7 which corresponds with historical trends in declining opioid use. This primary outcome is self-reported opioid disposal which is obtained via an automated text message sent to patients on post operative day 7.

  The duration of the study; two months

Study Arms (2)

Control

NO INTERVENTION

Usual care consisted of a text message hyperlink to nearby disposal locations.

Intervention

EXPERIMENTAL

Intervention participants were mailed an at-home disposal packet timed to arrive between post-operative days four and seven based on prior data collection on reported use.

Other: Medication Disposal Packet

Interventions

Medication Disposal Packet OTHER

The disposal packet (DisposeRx Inc.) contains a powder that sequesters unused opioids in a polymer gel. The kits reached patients four days following their surgery based on prior data to leverage availability bias, or a tendency to think or act on things that are most present in one's mind, and provided patients with a disposal technique when they were likely to be finished with their opioids. The process of mailing the disposal packet is simple, low cost (\~$1.50/ mailed packet) and scalable.

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 or older
• Undergoing an orthopedic or urologic procedure
• Prescribed an opioid
• SMS capable mobile device
• English speaking

You may not qualify if:

• Under 18
• Does not own a text message capable mobile phone
• non-English speaking

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (6)

• 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

• Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA Surg. 2017 Nov 1;152(11):1066-1071. doi: 10.1001/jamasurg.2017.0831.

  PMID: 28768328 BACKGROUND

• Kennedy-Hendricks A, Gielen A, McDonald E, McGinty EE, Shields W, Barry CL. Medication Sharing, Storage, and Disposal Practices for Opioid Medications Among US Adults. JAMA Intern Med. 2016 Jul 1;176(7):1027-9. doi: 10.1001/jamainternmed.2016.2543. No abstract available.

  PMID: 27295629 BACKGROUND

• Brummett CM, Steiger R, Englesbe M, Khalsa C, DeBlanc JJ, Denton LR, Waljee J. Effect of an Activated Charcoal Bag on Disposal of Unused Opioids After an Outpatient Surgical Procedure: A Randomized Clinical Trial. JAMA Surg. 2019 Jun 1;154(6):558-561. doi: 10.1001/jamasurg.2019.0155.

  PMID: 30916733 BACKGROUND

• Agarwal Anish K., Ali Zarina S., Sennett Brian, et al. An Automated Text Messaging Program to Inform Postoperative Opioid Prescribing. NEJM Catal [Internet] [cited 2021 Feb 18];2(3). Available from: https://doi.org/10.1056/CAT.20.0440

  BACKGROUND

• Agarwal AK, Lee D, Ali Z, Sennett B, Xiong R, Hemmons J, Spencer E, Abdel-Rahman D, Kleinman R, Lacko H, Horan A, Dooley M, Hume E, Mehta S, Delgado MK. Patient-Reported Opioid Consumption and Pain Intensity After Common Orthopedic and Urologic Surgical Procedures With Use of an Automated Text Messaging System. JAMA Netw Open. 2021 Mar 1;4(3):e213243. doi: 10.1001/jamanetworkopen.2021.3243.

  PMID: 33764425 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anish Agarwal, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Daniel Lee, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Zarina Ali, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to their random assignment into the control or treatment (medication disposal packet) group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Chief Wellness Officer | Department of Emergency Medicine

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 23, 2021
• Study Start: March 24, 2021
• Primary Completion: April 28, 2021
• Study Completion: May 26, 2021
• Last Updated: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)