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

Yale University

Status: Completed

Conditions: Opioid Prescribing; Opioid Use

Treatments: Drug: Short-acting opioid prescription for acute pain

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04509115

2000027561

2U01FD005938-03

Details and patient eligibility

About

This study will characterize patient pain and opioid use after an initial opioid prescription for acute pain.

Full 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

Enrollment: 1,709 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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.

Trial design

1,709 participants in 1 patient group

Patients given short-acting opioid prescription

Description:

Patients not currently using opioids who receive a new short-acting opioid prescription for acute pain will be recruited.

Treatment:

Drug: Short-acting opioid prescription for acute pain