Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

Analgesia Clinical Trial

Official title:

Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04564729
• Other study ID #: 2020P002342
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2022
• Source: Brigham and Women's Hospital
• Contact: Naida Cole, MD
• Phone: 9176576692
• Email: nmcole[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: September 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leftover opioid pills		30 days postoperatively
Primary	Average 0-10 NRS pain score		postoperative day 7
Secondary	Quantity of opioid consumed		30 days postoperatively
Secondary	Satisfaction with pain management		30 days postoperatively
Secondary	Quantity of opioid pills prescribed		postoperative day 1 at hospital discharge