UnknownNot Applicable

Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

United States142 participantsStarted 2020-11-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Leftover opioid pills

Timeframe: 30 days postoperatively

Average 0-10 NRS pain score

Timeframe: postoperative day 7

Trial details

NCT IDNCT04564729

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-30

Contact for this trial

Naida Cole, MD

9176576692 nmcole@bsd.uchicago.edu

View on ClinicalTrials.gov More Knee Arthroplasty, Total trials