Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations

Overview

About this study

This is a prospective observational cohort study.

This study will address important gaps in knowledge that hamper the development of evidence-based guidelines for acute pain management by prospectively following patients for 180 days and collecting detailed information on patients’ self-reported experience of pain and their corresponding analgesic use.

This study will invite opioid-naïve patients receiving an opioid prescription for the treatment of acute pain in primary or urgent care, an emergency department, or a dental office. Opioid naive patients are those who self-report no opioid use in the prior 6 months. For the purpose of the study, acute pain is defined as pain that started less than 8 weeks before entry in the study. The study will follow consented patients prospectively for 180 days, tracking their pain and treatment patterns using a novel patient-centered health data sharing platform – Hugo – that will consolidate data from patient-reported outcomes, pharmacy records, and electronic health records.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 15 and over (15+ will only occur in dental setting).
  • 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.
    • We do not anticipate many opioid-naïve people receiving an opioid analgesic for acute pain will receive the following drugs, however, we will not exclude otherwise eligible patients who receive one of the following drugs: 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.
  • Opioid naive (no use of prescribed opioids or illicit opioids, including medical or non-medical use, in the past 6 months) by self-report.
  • Willing and able to give consent and participate in study.
  • Able to access a mobile device (smartphone or tablet) with web access every day to complete study surveys.
  • Willing to connect Fitbit to a device 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 Criteria: 

  • 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Molly Jeffery, Ph.D.

Closed for enrollment

Contact information:

Emma Behnken

(507) 293-0177

Behnken.Emma@mayo.edu

More information

Publications

Publications are currently not available