Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

NCT04564729 | Unknown

• 1 other identifier: 2020P002342
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Arthroplasty, Total; Analgesia; Opioid Use, Unspecified

Outcome Measures

Primary Outcomes (2)

• Leftover opioid pills

  30 days postoperatively

• Average 0-10 NRS pain score

  postoperative day 7

Secondary Outcomes (3)

• 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

Study Arms (2)

Decision Aid

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Shared Decision Making OTHER

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.

Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Naida Cole, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naida Cole, MD

CONTACT

9176576692; nmcole@bsd.uchicago.edu

Laura Mendez, MD

CONTACT

8574004065; lmendez-pino@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators not involved in administering the SDA and data collection will be blinded. The study subject and investigator(s) involved in administering the SDA and collecting outcomes data will be unblinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: November 2, 2020
• Primary Completion: August 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)