Distribution of Medication Disposal Packets - Acute Opioid Prescribing

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT05169281
Collaborator
(none)
657
1
2
2.1
317.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Medication Disposal Packet
N/A

Detailed Description

A pragmatic, cluster-randomized quality improvement study embedded in an existing automated, post-operative text messaging program to capture patient-reported outcomes (e.g., pain score, opioid use, ability to manage pain) and disposal as part of usual care. It was approved by the University of Pennsylvania Institutional Review Board with a waiver of informed consent.

All patients, 18 years or older, undergoing an orthopedic or urologic procedure and prescribed an opioid were approached and consented via text messaging. Patients without access to a text message capable device or non-English speaking were excluded. Participants were block randomized to usual care or a mailed at-home disposal packet. Usual care consisted of a text message hyperlink to nearby disposal locations. 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. The disposal packet (DisposeRx Inc.) contains a powder that sequesters unused opioids in a polymer gel. Patients self-reported disposal via the automated system.

Study Design

Study Type:
Interventional
Actual Enrollment :
657 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participant will be blinded to their random assignment into the control or treatment (medication disposal packet) group
Primary Purpose:
Prevention
Official Title:
Cluster Randomized Trial of a Mailed At-home Kit on Disposal of Unused Opioids Following Surgery
Actual Study Start Date :
Mar 24, 2021
Actual Primary Completion Date :
Apr 28, 2021
Actual Study Completion Date :
May 26, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

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

Experimental: Intervention

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
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.

Outcome Measures

Primary Outcome Measures

  1. Self-Reported Opioid Disposal [The duration of the study; two months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adults 18 or older

  • Undergoing an orthopedic or urologic procedure

  • Prescribed an opioid

  • SMS capable mobile device

  • English speaking

Exclusion Criteria:
  • Under 18

  • Does not own a text message capable mobile phone

  • non-English speaking

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

  • Principal Investigator: Anish Agarwal, MD, University of Pennsylvania
  • Principal Investigator: Daniel Lee, MD, University of Pennsylvania
  • Principal Investigator: Zarina Ali, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Anish Agarwal, MD, MPH, MS, Assistant Professor & Chief Wellness Officer | Department of Emergency Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05169281
Other Study ID Numbers:
  • 827461_1
First Posted:
Dec 23, 2021
Last Update Posted:
Dec 23, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anish Agarwal, MD, MPH, MS, Assistant Professor & Chief Wellness Officer | Department of Emergency Medicine, University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 23, 2021