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Comprehensive Post-Surgery Care for Preventing Opioid Addiction
N/A
Waitlist Available
Led By Jeffrey L Schnipper, MD, MPH
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 180 days after discharge
Awards & highlights
Study Summary
This trial is testing a new way to help patients who are prescribed opioids after surgery to reduce the risk of developing opioid use disorder.
Who is the study for?
This trial is for adults in Massachusetts who are undergoing certain orthopedic surgeries at Brigham and Women's Hospital. It includes both opioid-naïve patients and those with prior opioid use, provided they're not currently using illicit opioids or have a condition requiring opioids post-surgery. Participants must be able to consent and speak English or Spanish.Check my eligibility
What is being tested?
The study tests a comprehensive approach to manage pain after major surgery, aiming to prevent long-term opioid use and addiction. This includes pharmacist-led counseling at discharge, standardized prescribing practices, follow-up visits for pain management, and an app for monitoring pain outcomes.See study design
What are the potential side effects?
Since this trial focuses on prevention strategies rather than medication side effects per se, the main risks involve potential privacy concerns with the app data collection and possible stress due to additional follow-up requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days after discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days after discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Persistent Opioid Use
Secondary outcome measures
Function
Long-term Opioid Episodes
Opioid Use on Discharge
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment4 Interventions
Discharge counseling; discharge opioid order set; post-discharge pain management follow up; patient pain management app.
Group II: Usual careActive Control1 Intervention
inpatient pharmacists as available; standard discharge orders; standard follow up visit.
Find a Location
Who is running the clinical trial?
Ohio State UniversityOTHER
821 Previous Clinical Trials
500,931 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,599 Previous Clinical Trials
11,462,310 Total Patients Enrolled
Jeffrey L Schnipper, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital
7 Previous Clinical Trials
4,539 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using illegal opioids.You need another surgery or have a medical condition that requires taking opioids for the 6 months following the study.You must speak either English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on participant numbers for this clinical trial?
"Affirmative. According to clinicaltrials.gov, recruitment for this research is ongoing and began on the 2nd of July 2021; with the last update occurring on October 19th 2022. This study requires 270 participants at a single site."
Answered by AI
Are there opportunities for people to join this research endeavor?
"Clinicaltrials.gov confirms that this medical experiment is presently enrolling participants, with the first posting occurring on July 2nd 2021 and its last update carried out on October 19th 2022."
Answered by AI
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