Opioid Education in Total Knee Arthroplasty

Study Overview
=================
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.

Official Title
-----------------
Effect of Perioperative Opioid Education on Outcomes After Total Knee Arthroplasty: A Randomized Study

Conditions
-----------------
Arthropathy of Knee, Post Operative Pain, Opioid Use, Opioid Abuse, Opioid Misuse

Intervention / Treatment
-----------------
* Other: Opioid education in person
* Other: Opioid education via video


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery. | |
| Experimental: In-person and PDF<br>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. | Other: Opioid education in person<br>* 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<br>|
| Experimental: Video and PDF<br>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. | Other: Opioid education via video<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid Education