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Orthopedic SurgeryNCT05169281

Distribution of Medication Disposal Packets - Acute Opioid Prescribing

A study testing Medication Disposal Packet in people with Orthopedic Surgery and Neurosurgery, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Orthopedic Surgery, Neurosurgery, Surgery
What is being tested?
Medication Disposal Packet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
657 participants
Where
1 siteUnited States
Study dates
24 Mar 2021to 26 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Medication Disposal Packet
Keywords
Opioid Prescribing, Mobile Health, Quality Improvement, Learning Health Systems
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication Disposal PacketOther

    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.

Study groups in NCT05169281
Study groupRoleWhat they receive
ControlNo interventionUsual care consisted of a text message hyperlink to nearby disposal locations.
InterventionExperimentalIntervention 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.
Receives: Other: Medication Disposal Packet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: The duration of the study; two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start24 Mar 2021
  3. Primary completion28 Apr 2021
  4. Study completion26 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
657 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05169281
Sponsor's protocol ID
827461_1
Status last verified
Jun 2023
First submitted
19 Nov 2021
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: individual participant data will not be shared.

Publications

  • 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.

    PubMed 27631771

  • 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.

    PubMed 28768328

  • 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.

    PubMed 27295629

  • 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.

    PubMed 30916733

  • 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

  • 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.

    PubMed 33764425

Questions about this trial

What is this clinical trial studying?

A study testing Medication Disposal Packet in people with Orthopedic Surgery and Neurosurgery, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Reported Opioid Disposal (time frame: The duration of the study; two months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05169281, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.

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