NCT04509115

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,709 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 prescription for an opioid in primary and urgent care, inpatient care (child birth and total knee arthroplasty), and in the emergency department. Patients not currently using opioids who receive a new short-acting opioid prescription for acute pain will be recruited and followed prospectively for 180 days to assess pain trajectories, analgesic and non-pharmacologic treatment use, activity, and health care service use. The patient-centered health data sharing platform (Hugo) will be used to collect patient-reported outcomes and structured data from pharmacy and electronic health records patient portals as well as patient-generated data collected through personal digital devices (Fitbit). Specific aims 1. To assess patients' pain and opioid use patterns in episodes of acute pain for which opioids were prescribed, characterizing pain severity and persistence, as well as other prescription and over-the-counter pain medication use 2. To examine associations between patient demographic, clinical and emotional characteristics and outcomes of pain severity and persistence, opioid and non-opioid treatment patterns, satisfaction with care, and barriers to care 3. To assess how patients handled unused opioids

Conditions

• Opioid Use
• Opioid Prescribing

Interventions

Type	Name	Description
DRUG	Short-acting opioid prescription for acute pain	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.

Timeline

• Start date: 2020-09-11
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2020-08-11
• Last updated: 2023-12-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study