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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04564729
Other study ID # 2020P002342
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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