eMethods. Study Population, Data Collection, Statistical Analysis, and Study Flowchart
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Agarwal AK, Lee D, Ali Z, et al. Effect of Mailing an At-home Disposal Kit on Unused Opioid Disposal After Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(5):e2210724. doi:10.1001/jamanetworkopen.2022.10724
Many prescription opioids after surgery are left unused and are at risk of being misused.1,2 Encouraging proper disposal is important, yet motivating this behavior remains challenging because patients must understand the risks of opioid use and the benefits of disposal and identify methods of safe disposal.3 We sought to test the effect of a mailed at-home disposal kit on disposal rates of unused opioids after surgery.
This 2-arm, randomized clinical trial compared usual care vs a mailed at-home disposal kit that was embedded in an existing postoperative text messaging program designed to capture patient-reported outcomes data and self-reported disposal.4 The trial protocol is available in Supplement 1. The study was approved by the University of Pennsylvania Institutional Review Board with a waiver of informed consent. The trial took place from April 19 to June 1, 2021, and followed the CONSORT reporting guideline.
All patients 18 years or older undergoing an orthopedic or urologic procedure and prescribed an opioid replied through a text messaging platform using an established protocol.5 Patients without access to a short messaging service–capable device or who did not speak English were excluded. Participants were electronically block randomized in groups of 2 or 4 to usual care or a mailed at-home disposal kit immediately after consent (eMethods in Supplement 2). Usual care consisted of a text message hyperlink to nearby disposal locations. Intervention participants were mailed an at-home disposal kit timed to arrive on postoperative day 4 to 7 based on prior data and designed to provide patients with a disposal method when they were most likely to be finished taking opioids.5 The disposal kit (DisposeRx Inc.) sequesters tablets in a polymer gel. Patients self-reported disposal via text messaging. Baseline self-reported disposal rates were 25% to 30%. We estimated 75 patients per group, assuming a 2-sided α = .025, a β of 80%, and a 50% relative increase in self-reported disposal. The primary outcome of interest was self-reported disposal. All randomized participants were included in an intention-to-treat analysis, and statistical analyses were performed using Fisher exact and χ2 tests via R, version 3.60 (R Project for Statistical Computing).
Of 657 patients invited to participate, 302 (46.0%) consented. Demographic information was obtained from the electronic health record to evaluate characteristics of respondents and nonrespondents. Participants had a median age of 56.5 (IQR, 40.0-65.8) years; 136 (45.0%) were women and 166 (55.0%) were men; 240 (79.5%) were White and 44 (14.6%) were Black; and 235 (77.8%) completed all questions. Consenting participants were younger than individuals who declined or did not respond (median age, 59.0 [IQR, 47.0-68.0] years), and more consenting participants than nonparticipants were White (215 of 355 [60.6%]). Participants were more likely than nonparticipants to be opioid naive (225 of 302 [74.5%] vs 225 of 355 [63.4%]) (Table 1). The odds of self-reported disposal were 2.01 (95% CI, 1.2-3.4) times higher in the intervention group. Among the 235 participants who completed all questions, 47 of 110 (42.7%) in the usual care group self-reported disposal, compared with 75 of 125 (60.0%) in the intervention group (Table 2). An estimated additional 480 unused opioid tablets were disposed of in the intervention group.
Opioid disposal remains important, but motivating disposal remains challenging. In this randomized clinical trial, a mailed at-home disposal kit increased self-reported opioid disposal rates after common surgical procedures. Efforts to encourage disposal are growing, yet research in scalable and patient-centered approaches is lacking. The demonstrated impact has high potential for a low cost solution. This study is limited in that it relied on self-reported disposal and reflects a single center’s experience; in addition, consenting patients were more likely to be younger and White, which limits generalizability. However, the findings build on literature suggesting that providing patients with at-home disposal options can improve self-reported disposal rates.6 The process of mailing the disposal kit is simple, inexpensive (approximately $1.50 per mailed kit), and scalable.
Accepted for Publication: March 19, 2022.
Published: May 6, 2022. doi:10.1001/jamanetworkopen.2022.10724
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Agarwal AK et al. JAMA Network Open.
Corresponding Author: Anish K. Agarwal, MD, MPH, MS, Department of Emergency Medicine, University of Pennsylvania, 423 Guardian Dr, 428 Blockley Hall, Philadelphia, PA 19104 (email@example.com).
Author Contributions: Dr Agarwal had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Agarwal, Lee, Ali, Coniglio, Uritsky, Delgado.
Acquisition, analysis, or interpretation of data: Agarwal, Lee, Wu, Delgado.
Drafting of the manuscript: Agarwal, Lee, Wu.
Critical revision of the manuscript for important intellectual content: Agarwal, Lee, Ali, Coniglio, Uritsky, Delgado.
Statistical analysis: Agarwal, Wu.
Obtained funding: Agarwal, Ali, Coniglio, Delgado.
Administrative, technical, or material support: Agarwal, Lee, Coniglio.
Supervision: Agarwal, Lee, Delgado.
Conflict of Interest Disclosures: Dr Agarwal reported receiving grants from the US Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, the Patient-Centered Outcomes Research Institute, and the University of Pennsylvania Institute for Translational Medicine and Therapeutics during the conduct of the study. Dr Uritsky reported receiving a stipend for serving on the advisory board of AcelRx Pharmaceuticals Inc outside the submitted work. Dr Delgado reported receiving grants from the FDA, the National Institutes of Health, and Abramson Family Foundation during the conduct of the study. No other disclosures were reported.
Funding/Support: This study was supported by grant HHSF223201810209C from the FDA (University of Pennsylvania Institute for Translational Medicine and Therapeutics). DisposeRx Inc previously provided disposal kits to the University of Pennsylvania Health System as an in-kind donation.
Role of the Funder/Sponsor: DisposeRx and the sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Trial Registration: ClinicalTrials.gov Identifier: NCT05169281
Data Sharing Statement: See Supplement 3.