Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

This will be a randomized controlled clinical trial in patients who have undergone primary unilateral total knee arthroplasty at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center. Study subjects will receive either a shared decision aid (SDA) about pain management or standard of care at the time of discharge. The impact of the SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7 will be assessed.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Knee Arthroplasty, Total; Opioid Use, Unspecified
• Intervention / Treatment: Other: Shared Decision Making

Detailed Description

This study will be a randomized controlled trial for primary, unilateral total knee arthroplasty (TKA) patients at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center to determine the impact of using a SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7.

The SDA includes factual information about the World Health Organization pain ladder, the 0-10 NRS pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in TKA patients. The SDA has been developed by the principal investigator solely for the purpose of this study.

Patients will be enrolled on postoperative day 0 or 1 and randomized to intervention or control groups. The intervention group will view the SDA slides on the study iPad. SDA viewing will be guided by the research assistant, who will read a pre-written script as each slide is viewed. Following the guided viewing of the SDA, subjects in the intervention group will have the opportunity to ask questions to the research assistant to confirm their comprehension of the presented facts. The control group will receive no intervention and will receive standard of care and standard discharge prescriptions. The intervention group subjects will choose the number of opioid pills they wish to include in their discharge opioid prescription (anywhere from 0 to the maximum allowable as determined by clinical practice and/or state law).

Daily analgesic intake, adverse effects and numeric rating scale (NRS) pain scores will be collected and analyzed.

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naida Cole, MD; Phone Number: 9176576692; Email: nmcole@bsd.uchicago.edu
• Study Contact Backup: Name: Laura Mendez, MD; Phone Number: 8574004065; Email: lmendez-pino@bwh.harvard.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
      • Contact: Naida Cole, MD; Email: nmcole@bsd.uchicago.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Jose Zeballos, MD; Email: jzeballos@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary unilateral TKA under spinal anesthesia at Brigham & Women's Faulkner Hospital (BWFH), Brigham and Women's Hospital or University of Chicago Medical Center by a participating surgeon
• >18 years of age

• Planned discharge with the typical analgesic medications prescribed at discharge:

  • standing around-the clock Tylenol with or without an NSAID
  • tramadol PRN
  • hydromorphone (dilaudid) or oxycodone PRN

Exclusion Criteria:

• Diagnosis of dementia
• <18 years old
• Contraindication or allergy to opioids
• Contraindication or allergy to Tylenol
• Contraindication or allergy to gabapentin
• History of substance use disorder
• Preoperative pain requiring a >1-month prescription for >/=45 daily MMEs
• 4 or more preoperative analgesic prescriptions
• Hospital admission >1 day
• Discharge to a skilled nursing facility/inpatient rehabilitation center
• Non-English speaking patients
• Requirement for general anesthesia intra-operatively

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decision Aid; The shared decision aid (SDA) includes factual information about the World Health Organization pain ladder, the 0-10 numeric rating score pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in total knee arthroplasty patients. Subjects in the decision aid group will view the decision aid and have the opportunity to participate in shared decision-making for their discharge opioid prescriptions.	Other: Shared Decision Making; The intervention group will receive a shared decision-making intervention including a decision aid and conversation with a study investigator. The intervention group will have the opportunity to choose the number of opioid pills they receive at discharge from hospital after total knee arthroplasty.
No Intervention: Control; Subjects in the control group will undergo standard care and discharge practices. Baseline pain and psychosocial factors will be documented as well as postoperative pain and analgesic consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Leftover opioid pills	30 days postoperatively
Average 0-10 NRS pain score	postoperative day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Quantity of opioid consumed	30 days postoperatively
Satisfaction with pain management	30 days postoperatively
Quantity of opioid pills prescribed	postoperative day 1 at hospital discharge

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Naida Cole, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020P002342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No