Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2022-09-27
2023-09-11
Brief Summary
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1. Does perioperative education pathway reduce opioid refill requests?
2. Is education pathway that focuses on pain management provided in-person and via video in repeated sessions more effective than current standard of care education consisting of a single exposure given as part of a broader preoperative presentation covering multiple topics?
3. Is there a difference between education provided in-person vs video?
4. Does perioperative education improve compliance with multimodal analgesia?
5. Does perioperative education improve appropriate opioid storage?
6. Does perioperative education improve appropriate opioid disposal?
Enrolled patients will be assigned at random to one of 3 study groups. Group 1 (control): Patients are referred to the hospital's standard 1-hour virtual patient education webinar prior to surgery.
Group 2 (in-person): Patients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive portable document format (pdf) handouts about opioid and pain management.
Group 3 (video): Patients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioid and pain management.
Detailed Description
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The current education process at HSS involves patient referral to a virtual webinar which is optional. Pain topics are covered within a broader 50-minute presentation on numerous topics related to surgery. Information on pain topics may be difficult to process and retain because it is a single exposure that is combined with multiple unrelated topics, and there is no repetition or reference provided. The aim of this study is to explore how a comprehensive educational pathway focusing on aspects of pain control and proper opioid use with repeated sessions will affect outcomes after total knee arthroplasty by comparing three groups - 1) patients who attend the virtual webinar, 2) an in-person session with a portable document format (PDF), and 3) a video session with PDF.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control Group
Patients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery.
No interventions assigned to this group
In-person and PDF
Patients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management.
Opioid education in person
The presentation and handouts contain information regarding the following topics:
* Reviewing opioids and strategies for analgesia
* Defining and identifying opioids
* Goals for postoperative pain management and utilizing opioids to treat pain
* Alternative modes of treating pain
* Regional anesthesia/analgesia defined
* Side effects and risks of opioids
* Common side effects of opioids
* Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use
* Proper use and handling of opioids
* Safe practices when taking opioids
* Weaning off opioids
* Safe storage and disposal of opioids
Video and PDF
Patients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management.
Opioid education via video
The video and handouts contain information regarding the following topics:
* Reviewing opioids and strategies for analgesia
* Defining and identifying opioids
* Goals for postoperative pain management and utilizing opioids to treat pain
* Alternative modes of treating pain
* Regional anesthesia/analgesia defined
* Side effects and risks of opioids
* Common side effects of opioids
* Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use
* Proper use and handling of opioids
* Safe practices when taking opioids
* Weaning off opioids
* Safe storage and disposal of opioids
Interventions
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Opioid education in person
The presentation and handouts contain information regarding the following topics:
* Reviewing opioids and strategies for analgesia
* Defining and identifying opioids
* Goals for postoperative pain management and utilizing opioids to treat pain
* Alternative modes of treating pain
* Regional anesthesia/analgesia defined
* Side effects and risks of opioids
* Common side effects of opioids
* Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use
* Proper use and handling of opioids
* Safe practices when taking opioids
* Weaning off opioids
* Safe storage and disposal of opioids
Opioid education via video
The video and handouts contain information regarding the following topics:
* Reviewing opioids and strategies for analgesia
* Defining and identifying opioids
* Goals for postoperative pain management and utilizing opioids to treat pain
* Alternative modes of treating pain
* Regional anesthesia/analgesia defined
* Side effects and risks of opioids
* Common side effects of opioids
* Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use
* Proper use and handling of opioids
* Safe practices when taking opioids
* Weaning off opioids
* Safe storage and disposal of opioids
Eligibility Criteria
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Inclusion Criteria
* Undergoing primary total knee replacement surgery at Hospital for Special Surgery
* English speaking
Exclusion Criteria
* Opioid use within the past 3 months
* Contraindication to NSAIDs or acetaminophen
* Contraindication or allergy to opioids
* Contraindication to any study medications (i.e., fentanyl, ketamine, versed, acetaminophen, ketorolac, zofran, decadron)
* Discharge to rehab or skilled nursing facility (opioids are not prescribed by HSS providers)
* Contraindication or refusal to receive neuraxial anesthesia or peripheralnerve blocks (PNB)
* Revision surgery
* Ambulatory surgery
* Patients who are pregnant
18 Years
80 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Bradley H Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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References
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Lee BH, Wu CL. Educating Patients Regarding Pain Management and Safe Opioid Use After Surgery: A Narrative Review. Anesth Analg. 2020 Mar;130(3):574-581. doi: 10.1213/ANE.0000000000004436.
Syed UAM, Aleem AW, Wowkanech C, Weekes D, Freedman M, Tjoumakaris F, Abboud JA, Austin LS. Neer Award 2018: the effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Shoulder Elbow Surg. 2018 Jun;27(6):962-967. doi: 10.1016/j.jse.2018.02.039. Epub 2018 Mar 26.
Egan KG, De Souza M, Muenks E, Nazir N, Korentager R. Opioid Consumption Following Breast Surgery Decreases with a Brief Educational Intervention: A Randomized, Controlled Trial. Ann Surg Oncol. 2020 Sep;27(9):3156-3162. doi: 10.1245/s10434-020-08432-7. Epub 2020 Apr 13.
Horn A, Kaneshiro K, Tsui BCH. Preemptive and Preventive Pain Psychoeducation and Its Potential Application as a Multimodal Perioperative Pain Control Option: A Systematic Review. Anesth Analg. 2020 Mar;130(3):559-573. doi: 10.1213/ANE.0000000000004319.
Memtsoudis SG, Poeran J, Zubizarreta N, Cozowicz C, Morwald EE, Mariano ER, Mazumdar M. Association of Multimodal Pain Management Strategies with Perioperative Outcomes and Resource Utilization: A Population-based Study. Anesthesiology. 2018 May;128(5):891-902. doi: 10.1097/ALN.0000000000002132.
Stepan JG, Sacks HA, Verret CI, Wessel LE, Kumar K, Fufa DT. Standardized Perioperative Patient Education Decreases Opioid Use after Hand Surgery: A Randomized Controlled Trial. Plast Reconstr Surg. 2021 Feb 1;147(2):409-418. doi: 10.1097/PRS.0000000000007574.
Nahhas CR, Hannon CP, Yang J, Gerlinger TL, Nam D, Della Valle CJ. Education Increases Disposal of Unused Opioids After Total Joint Arthroplasty: A Cluster-Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Jun 3;102(11):953-960. doi: 10.2106/JBJS.19.01166.
Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
Sheetz M, Puglisi A, Trentalange M, Reichel J, Chalmers B, Gonzalez Della Valle A, Sideris A, Lee BH. Comparing modalities of opioid education in patients undergoing total knee arthroplasty: a randomized pilot trial. Reg Anesth Pain Med. 2024 Sep 26:rapm-2024-105701. doi: 10.1136/rapm-2024-105701. Online ahead of print.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2022-1286
Identifier Type: -
Identifier Source: org_study_id