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

Yale University1,709 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

1,709

Conditions

Opioid Use Opioid Prescribing

Interventions

Short-acting opioid prescription for acute painDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

University of Alabama Birmingham

Birmingham, Alabama, United States

Cedars Sinai

Los Angeles, California, United States

Yale-New Haven Health

New Haven, Connecticut, United States

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Opioid Pain medication use

Number of days using any opioid medications

Time frame: From baseline up to 180 days

Non-Opioid pain medication and treatment use

Number of days using any non-opioid drugs/treatments

Time frame: 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.

Time frame: From baseline up to 180 days

Secondary Outcomes

Time to opioid discontinuation

Discontinuation defined as 30 days with no opioid use. . If 30 days pass with no opioid use, but the participant takes an opioid on the 31st day, a new episode of opioid use will be considered to have started and the time to opioid discontinuation will again be measured.

Time frame: From initial opioid use to the day on which the last opioid was taken, up to 180 days.

Time to pain resolution

Pain resolution will be defined as patient no longer indicating pain in the body area initially treated, as indicated by either a) an overall pain rating of 0 on the brief pain inventory scale from 0 to 10, with 0 being no pain and 10 the worst pain imaginable, or b) the patient no longer selects the body area initially treated when completing the body map of areas where patient is experiencing pain).

Time frame: From baseline up to 180 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.