Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
2 other identifiers
observational
1,709
1 country
5
Brief Summary
This study will characterize patient pain and opioid use after an initial opioid prescription for acute pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2020
CompletedFirst Posted
Study publicly available on registry
August 11, 2020
CompletedStudy Start
First participant enrolled
September 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedDecember 5, 2023
December 1, 2023
3.2 years
August 7, 2020
December 1, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Opioid Pain medication use
Number of days using any opioid medications
From baseline up to 180 days
Non-Opioid pain medication and treatment use
Number of days using any non-opioid drugs/treatments
From baseline up to 180 days
Pain medication use concordant with directions for use
Comparison of directions for use and actual use: For each day the person takes opioids, measure whether the number of pills taken falls within the range prescribed, below the prescribed range, or above the prescribed range. The overall proportion of days taking less than the prescribed range, within the prescribed range, and over the prescribed range will be calculated for each patient and the distribution of these measures will be plotted as histograms and reported as the median, 25th percentile and 75th percentile.
From baseline up to 180 days
Secondary Outcomes (15)
Time to opioid discontinuation
From initial opioid use to the day on which the last opioid was taken, up to 180 days.
Time to pain resolution
From baseline up to 180 days
Average activity levels
From baseline up to 180 days
Treatment satisfaction
From baseline up to 180 days
Barriers to treatment
From baseline up to 180 days
- +10 more secondary outcomes
Study Arms (1)
Patients given short-acting opioid prescription
Patients not currently using opioids who receive a new short-acting opioid prescription for acute pain will be recruited.
Interventions
Patients not currently using opioids who receive a new short-acting opioid prescription as part of routine care for acute pain will be recruited and followed prospectively for 180 days.
Eligibility Criteria
The investigators will recruit a total of 1,550 patients receiving primary and urgent care, emergency department care, inpatient care (child birth and total knee arthroplasty), and dental care in 5 healthcare systems. Participants must be 18 years or older, be English- or Spanish-speaking, and be willing and able to consent for themselves.
You may qualify if:
- English- or Spanish-speaking
- Experiencing acute pain of less than 8 weeks duration at the time the opioid is prescribed
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Food and Drug Administration (FDA)collaborator
Study Sites (5)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Cedars Sinai
Los Angeles, California, 90048, United States
Yale-New Haven Health
New Haven, Connecticut, 06510, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Monument Health
Rapid City, South Dakota, 57701, United States
Related Publications (1)
Jeffery MM, Ahadpour M, Allen S, Araojo R, Bellolio F, Chang N, Ciaccio L, Emanuel L, Fillmore J, Gilbert GH, Koussis P, Lee C, Lipkind H, Mallama C, Meyer T, Moncur M, Nuckols T, Pacanowski MA, Page DB, Papadopoulos E, Ritchie JD, Ross JS, Shah ND, Soukup M, St Clair CO, Tamang S, Torbati S, Wallace DW, Zhao Y, Heckmann R. Acute pain pathways: protocol for a prospective cohort study. BMJ Open. 2022 Jul 5;12(7):e058782. doi: 10.1136/bmjopen-2021-058782.
PMID: 35790333DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Ross, MD, MHS
Yale University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2020
First Posted
August 11, 2020
Study Start
September 11, 2020
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
December 5, 2023
Record last verified: 2023-12