SAVE Trial: SAfe Opioid Use Video Education

Overview

The study will assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid epidemic, the judicious use of opioids, and the proper disposal of opioids. This trial is a single-institution, randomized controlled trial comparing total post-discharge opioid use in breast reconstruction patients who view an educational video on proper opioid use to patients who do not receive intentional education (the current standard of care). This will be the first project to inform opioid prescribing guidelines for breast reconstruction patients based on actual opioid use data and will describe a patient-centered intervention that is easily incorporated into current postoperative workflows. Broadly, the results of the study aim to set the foundation to incorporate cost-effective educational interventions across multiple surgical specialties that require postoperative opioid prescription.

Detailed description

Opioids are widely overprescribed and overused after surgery, contributing to the current opioid misuse crisis which affects more than 10 million Americans annually. In the breast reconstruction after mastectomy population, studies report as many as 47% of patients go on to become prolonged users of opioids.

The primary goal is to assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid epidemic, the judicious use of opioids, and the proper disposal of opioids. The proposed study is a single-institution, randomized controlled trial comparing total post-discharge opioid use in breast reconstruction patients who view an educational video on proper opioid use to patients who do not receive intentional education (the current standard of care). This project is directly relevant to the mission of the AHRQ to "improve health care patient safety and to provide a 360-degree view of the patient." Specifically, this will be the first project to inform opioid prescribing guidelines for breast reconstruction patients based on actual opioid use data and will describe a patient-centered intervention that is easily incorporated into current postoperative workflows. Broadly, the results of the study aim to set the foundation to incorporate cost-effective educational interventions across multiple surgical specialties that require postoperative opioid prescription.

Patients will be randomized to an opioid video vs. no opioid video cohort by a block randomization scheme based on a predefined computer-generated sequence (six blocks, six numbers per block) in a 1:1 intervention: no intervention ratio. Patients in the opioid video cohort will watch a 3-minute education video on proper opioid use preoperatively. The video includes information on (1) how to consume appropriate over-the-counter pain medication alongside opioids for optimal pain control, (2) how prescribed opioids should be used only to treat pain related to the surgery, and (3) the proper disposal of unused opioids. The video was created through the University of Utah Office of Patient Experience. Feedback regarding the educational content was provided by surgeons, pain management physicians, and pharmacists throughout the process.

Interventions

• Behavioral Opioid Educational Video
  The video includes information on (1) how to consume appropriate over-the-counter pain medication alongside opioids for optimal pain control, (2) how prescribed opioids should be used only to treat pain related to the surgery, and (3) the proper disposal of unused opioids. The video was created through the University of Utah Office of Patient Experience. Feedback regarding the educational content was provided by surgeons, pain management physicians, and pharmacists throughout the process.

Primary outcome measures

• Total Opioid Consumption [Time frame: up to 2 weeks postoperative]
• Days to Opioid Cessation [Time frame: up to 2 weeks postoperative]

Secondary outcome measures (5)

• Opioids Prescribed Consumed [Time frame: up to 2 weeks postoperative]
• Non-Opioid Analgesics Consumed [Time frame: up to 2 weeks postoperative]
• Days to Non-Opioid Analgesics Cessation [Time frame: up to 2 weeks postoperative]
• Patient-reported Daily Pain Scores [Time frame: up to 2 weeks postoperative]
• Complication Types [Time frame: up to 2 weeks postoperative]

Eligibility criteria

Inclusion criteria

• Female patients 18 years of age or older
• Patients undergoing abdominally based autologous free flap breast reconstruction after mastectomy for breast cancer or cancer prophylaxis

Exclusion criteria

• Patients undergoing reoperations such as autologous breast reconstruction as a revision procedure following failed implant-based reconstruction
• Patients undergoing multiple procedures such as mastectomy and immediate reconstruction
• Patients with documented chronic opioid use prior to procedure, chronic pain condition

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Utah Huntsman Cancer Institute — Salt Lake City

Publications

• Statistics NCfDA. Opioid Epidemic: Addiction Statistics. Accessed February 16, 2024, https://drugabusestatistics.org/opioid-epidemic/
• Marcusa DP, Mann RA, Cron DC, Fillinger BR, Rzepecki AK, Kozlow JH, Momoh A, Englesbe M, Brummett C, Waljee JF. Prescription Opioid Use among Opioid-Naive Women Undergoing Immediate Breast Reconstruction. Plast Reconstr Surg. 2017 Dec;140(6):1081-1090. doi: 10.1097/PRS.0000000000003832. PMID 29176408
• Samuel AR, Fuhr L, DeGeorge BR Jr, Black J, Campbell C, Stranix JT. Prolonged Opioid Use Among Opioid-Naive Women Undergoing Breast Reconstructive Surgery. Arch Plast Surg. 2022 May 27;49(3):339-345. doi: 10.1055/s-0042-1744419. eCollection 2022 May. PMID 35832151
• (OPEN) OPEN. OPEN Prescribing Recommendations. This document was retrieved from a website with the URL: https://doi.org/10.56137/OPEN.000054
• Batdorf NJ, Lemaine V, Lovely JK, Ballman KV, Goede WJ, Martinez-Jorge J, Booth-Kowalczyk AL, Grubbs PL, Bungum LD, Saint-Cyr M. Enhanced recovery after surgery in microvascular breast reconstruction. J Plast Reconstr Aesthet Surg. 2015 Mar;68(3):395-402. doi: 10.1016/j.bjps.2014.11.014. Epub 2014 Nov 21. PMID 25488326
• Muetterties CE, Taylor JM, Kaeding DE, Morales RR, Nguyen AV, Kwan L, Tseng CY, Delong MR, Festekjian JH. Enhanced Recovery after Surgery Protocol Decreases Length of Stay and Postoperative Narcotic Use in Microvascular Breast Reconstruction. Plast Reconstr Surg Glob Open. 2023 Dec 14;11(12):e5444. doi: 10.1097/GOX.0000000000005444. eCollection 2023 Dec. PMID 38098953
• Pierzchajlo N, Zibitt M, Hinson C, Stokes JA, Neil ZD, Pierzchajlo G, Gendreau J, Buchanan PJ. Enhanced recovery after surgery pathways for deep inferior epigastric perforator flap breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2023 Dec;87:259-272. doi: 10.1016/j.bjps.2023.10.058. Epub 2023 Oct 15. PMID 37924717
• Temple-Oberle C, Shea-Budgell MA, Tan M, Semple JL, Schrag C, Barreto M, Blondeel P, Hamming J, Dayan J, Ljungqvist O; ERAS Society. Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations. Plast Reconstr Surg. 2017 May;139(5):1056e-1071e. doi: 10.1097/PRS.0000000000003242. PMID 28445352

Identifiers

NCT: NCT07044583 · HCI186179

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗