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OpenTrials
Completed

NCT Number: NCT05169281

Distribution of Medication Disposal Packets - Acute Opioid Prescribing

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Self-Reported Opioid Disposal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Cluster Randomized Trial of a Mailed At-home Kit on Disposal of Unused Opioids Following Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2021
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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