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Opioid Education in Total Knee Arthroplasty

Primary Purpose

Arthropathy of Knee, Post Operative Pain, Opioid Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid education in person
Opioid education via video
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee focused on measuring Opioid Education

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between age 18 and 80 years old
  • Undergoing primary total knee replacement surgery at Hospital for Special Surgery
  • English speaking

Exclusion Criteria:

  • History of chronic opioid use (continuous opioid use for 3 or more months)
  • 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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

In-person and PDF

Video and PDF

Arm Description

Patients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery.

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.

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.

Outcomes

Primary Outcome Measures

Opioid refill at POD 30
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Opioid refill at POD 60
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.

Secondary Outcome Measures

Hospital length of stay
The total amount of time spent in-patient following their surgery.
Patient's health and recovery status following their surgery
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? Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with family or friends Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being Have you had any of the following in the last 24 hours? Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed
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'.
Opioid consumption
The amount of opioid consumption by the patient (in oral morphine equivalents).
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.
Rates of proper opioid storage
Patients will be asked to report how they are storing their opioids (i.e., stored "locked and hidden").
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).

Full Information

First Posted
September 30, 2022
Last Updated
September 27, 2023
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT05593341
Brief Title
Opioid Education in Total Knee Arthroplasty
Official Title
Effect of Perioperative Opioid Education on Outcomes After Total Knee Arthroplasty: A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
September 11, 2023 (Actual)
Study Completion Date
September 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

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
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: Does perioperative education pathway reduce opioid refill requests? 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? Is there a difference between education provided in-person vs video? Does perioperative education improve compliance with multimodal analgesia? Does perioperative education improve appropriate opioid storage? 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee, Post Operative Pain, Opioid Use, Opioid Abuse, Opioid Misuse
Keywords
Opioid Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery.
Arm Title
In-person and PDF
Arm Type
Experimental
Arm Description
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.
Arm Title
Video and PDF
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Opioid education in person
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Opioid education via video
Intervention Description
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
Primary Outcome Measure Information:
Title
Opioid refill at POD 30
Description
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Time Frame
Post operative day (POD) 30
Title
Opioid refill at POD 60
Description
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Time Frame
Post operative day (POD) 60
Secondary Outcome Measure Information:
Title
Hospital length of stay
Description
The total amount of time spent in-patient following their surgery.
Time Frame
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)
Title
Patient's health and recovery status following their surgery
Description
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? Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with family or friends Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being Have you had any of the following in the last 24 hours? Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed
Time Frame
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
Title
Numerical Rating Scale
Description
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'.
Time Frame
Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
Title
Opioid consumption
Description
The amount of opioid consumption by the patient (in oral morphine equivalents).
Time Frame
Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
Title
Rates of compliance with multimodal regimen
Description
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.
Time Frame
Post-operative day 1, Post-operative day 7, Post-operative day 14
Title
Rates of proper opioid storage
Description
Patients will be asked to report how they are storing their opioids (i.e., stored "locked and hidden").
Time Frame
Post-operative day 7
Title
Rates of proper opioid disposal
Description
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).
Time Frame
Post-operative day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between age 18 and 80 years old Undergoing primary total knee replacement surgery at Hospital for Special Surgery English speaking Exclusion Criteria: History of chronic opioid use (continuous opioid use for 3 or more months) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley H Lee, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available to other researchers.
Citations:
PubMed Identifier
31567320
Citation
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.
Results Reference
result
PubMed Identifier
29599038
Citation
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.
Results Reference
result
PubMed Identifier
32285282
Citation
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.
Results Reference
result
PubMed Identifier
31335400
Citation
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.
Results Reference
result
PubMed Identifier
29498951
Citation
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.
Results Reference
result
PubMed Identifier
33235041
Citation
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.
Results Reference
result
PubMed Identifier
32251139
Citation
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.
Results Reference
result
PubMed Identifier
16079372
Citation
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.
Results Reference
result

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Opioid Education in Total Knee Arthroplasty

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