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The goal of this experimental study is to compare different education intervention on opioid education for patients undergoing total knee arthroplasty. The specific research questions to address are:
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.
Patients undergoing surgery are frequently unaware of how to properly use opioids for pain management which may result in poor compliance with pain regimens, worse pain control and functional outcomes, and improper storage and disposal. There is evidence that educational interventions in various formats may improve pain and promote proper opioid handling. In addition, multimodal analgesia has been shown to be effective in total joint arthroplasty, and setting appropriate expectations may reduce anxiety, postoperative recovery time, and post surgical acute pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Patients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery. | |
| In-person and PDF | Experimental | 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. |
|
| Video and PDF | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid education in person | Other | The presentation and handouts contain information regarding the following topics:
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid refill at POD 30 | Patients will be asked if they have refilled their opioid prescription and the number of opioid refills. | Post operative day (POD) 30 |
| Opioid refill at POD 60 | Patients will be asked if they have refilled their opioid prescription and the number of opioid refills. | Post operative day (POD) 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | The total amount of time spent in-patient following their surgery. | From the time patient enters the post-anesthesia care unit (PACU entry) until the time patient is discharged from the hospital (discharge time), assessed up to 168 hours (1 week) |
| Patient's health and recovery status following their surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley H Lee, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31567320 | Result | 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. | |
| 29599038 | Result | 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. |
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There is no plan to make IPD available to other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2022 | Sep 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Opioid education via video | Other | The video and handouts contain information regarding the following topics:
|
|
A survey titled: quality of recovery 15 (QoR15) is a patient- reported outcome measure measuring quality of recovery after surgery and anesthesia. Each of the following question on the survey will be assessed on a 0-10 scale, with 0 meaning "none of the time" and 10 meaning "all of the time". How have you been feeling in the last 24 hours?
|
| Pre-operative (when patient is in the holding area being prepped for surgery), Post-operative day 1, Post-operative day 7, Post-operative day 14 |
| Numerical Rating Scale | Patients are asked to report a number between 0 and 10 that best measures their pain intensity. Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'. | Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14 |
| Opioid consumption | The amount of opioid consumption by the patient (in oral morphine equivalents). | Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14 |
| Rates of compliance with multimodal regimen | Patients will keep "pain diary" to record use of each medication (acetaminophen, NSAIDs, and opioid). Compliance will be defined as the percentage of prescribed medication (acetaminophen or NSAID) that is actually taken. | Post-operative day 1, Post-operative day 7, Post-operative day 14 |
| Rates of proper opioid storage | Patients will be asked to report how they are storing their opioids (i.e., stored "locked and hidden"). | Post-operative day 7 |
| Rates of proper opioid disposal | Patients will be asked to report how they are disposing of their unused opioids (i.e., reporting they dispose using one of the accepted proper disposal methods). | Post-operative day 21 |
| 32285282 | Result | 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. |
| 31335400 | Result | 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. |
| 29498951 | Result | 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. |
| 33235041 | Result | 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. |
| 32251139 | Result | 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. |
| 16079372 | Result | 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. |
| 39327049 | Derived | 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. 2026 Jan 5;51(1):60-68. doi: 10.1136/rapm-2024-105701. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |