NCT04564729

Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Arthroplasty, Total
• Analgesia
• Opioid Use, Unspecified

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-02
• Primary completion: 2022-08-30
• Completion: 2022-09-30
• First posted: 2020-09-25
• Last updated: 2022-05-27

Locations

2 sites across 1 country: United States