Status:
COMPLETED
Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
Lead Sponsor:
Yale University
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Opioid Use
Opioid Prescribing
Eligibility:
All Genders
18+ years
Brief Summary
This study will characterize patient pain and opioid use after an initial opioid prescription for acute pain.
Detailed Description
The purpose of this study is to characterize patient pain and opioid use after an initial opioid prescription for acute pain. The investigators aim to enroll a total of 300 patients receiving a prescr...
Eligibility Criteria
Inclusion
- English- or Spanish-speaking
- Experiencing acute pain of less than 8 weeks duration at the time the opioid is prescribed
- Received prescription for opioid analgesic at visit; opioids included in the study will be all FDA-approved enteral, transdermal, and transmucosal opioid analgesics including the most common: hydrocodone (except cough and anti-diarrheal medications), oxycodone, codeine (except cough medications), tramadol, morphine, hydromorphone. Receipt of a prescription for the following is not an exclusion: buprenorphine (as an analgesic), butorphanol, dihydrocodeine, fentanyl, meperidine, methadone (as an analgesic), oxymorphone, pentazocine, sufentanil, and tapentadol. All of these opioids are included in any combinations with acetaminophen, aspirin, ibuprofen, naloxone, etc.
- Self-report of no opioid use (no use of prescribed opioids or illicit opioids, including medical or non-medical use) in the past 6 months
- Willing and able to give consent and participate in study
- Able to access a device with web access (laptop, desktop, smartphone, or tablet) daily to complete study surveys
- Willing to connect Fitbit to a mobile device (smartphone or tablet) that can regularly link to Hugo for data transfer
- Willing to use the health data sharing platform
- Released/discharged to home after their visit.
Exclusion
- Pain thought to be caused by a systemic disease very likely to progress to chronic pain (e.g., sickle cell disease, fibromyalgia, lupus, multiple sclerosis, etc.);
- Cancer or end-of-life pain;
- Unable to give consent and be enrolled within 3 days of their visit.
Key Trial Info
Start Date :
September 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
1709 Patients enrolled
Trial Details
Trial ID
NCT04509115
Start Date
September 11 2020
End Date
November 30 2023
Last Update
December 5 2023
Active Locations (5)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
2
Cedars Sinai
Los Angeles, California, United States, 90048
3
Yale-New Haven Health
New Haven, Connecticut, United States, 06510
4
Mayo Clinic
Rochester, Minnesota, United States, 55905