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Shared Decision Making for Pain relief

N/A
Recruiting
Led By Naida Cole, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days postoperatively
Awards & highlights

Study Summary

This trial will test whether a shared decision aid given to patients at discharge after primary unilateral total knee arthroplasty can help manage pain better.

Eligible Conditions
  • Pain relief
  • Total Knee Replacement
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average 0-10 NRS pain score
Leftover opioid pills
Secondary outcome measures
Quantity of opioid consumed
Quantity of opioid pills prescribed
Satisfaction with pain management

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Decision AidExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 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.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,606 Previous Clinical Trials
11,467,164 Total Patients Enrolled
Naida Cole, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
Naida Margaret Cole 2020. "Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04564729.
~32 spots leftby Apr 2025
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