search
Back to results

Distribution of Medication Disposal Packets - Acute Opioid Prescribing

Primary Purpose

Orthopedic Surgery, Neurosurgery, Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication Disposal Packet
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Orthopedic Surgery focused on measuring Opioid Prescribing, Mobile Health, Quality Improvement, Learning Health Systems

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2021
Last Updated
June 1, 2023
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT05169281
Brief Title
Distribution of Medication Disposal Packets - Acute Opioid Prescribing
Official Title
Cluster Randomized Trial of a Mailed At-home Kit on Disposal of Unused Opioids Following Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Surgery, Neurosurgery, Surgery, Opioid Use, Opioid Misuse
Keywords
Opioid Prescribing, Mobile Health, Quality Improvement, Learning Health Systems

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participant will be blinded to their random assignment into the control or treatment (medication disposal packet) group
Allocation
Randomized
Enrollment
657 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care consisted of a text message hyperlink to nearby disposal locations.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medication Disposal Packet
Intervention Description
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 Outcome Measure Information:
Title
Self-Reported Opioid Disposal
Description
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.
Time Frame
The duration of the study; two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anish Agarwal, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Lee, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zarina Ali, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
individual participant data will not be shared.
Citations:
PubMed Identifier
27631771
Citation
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.
Results Reference
background
PubMed Identifier
28768328
Citation
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.
Results Reference
background
PubMed Identifier
27295629
Citation
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.
Results Reference
background
PubMed Identifier
30916733
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
33764425
Citation
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.
Results Reference
background

Learn more about this trial

Distribution of Medication Disposal Packets - Acute Opioid Prescribing

We'll reach out to this number within 24 hrs