Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

Not Applicable

• Conditions: Knee Arthroplasty, Total; Analgesia; Opioid Use, Unspecified
• Interventions: Other: Shared Decision Making

• Registration Number: NCT04564729
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-25
• Study Start: 2020-11-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-27
• Primary Completion: 2022-08-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decision Aid	Shared Decision Making	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.

Primary Outcome Measures

Name	Time	Method
Average 0-10 NRS pain score	postoperative day 7
Leftover opioid pills	30 days postoperatively

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States