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

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

Study Overview

• Status: Completed
• Conditions: Opioid Use; Opioid Prescribing
• Intervention / Treatment: Drug: Short-acting 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

• Study Type: Observational
• Enrollment (Actual): 1709

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Birmingham
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	From baseline up to 180 days
Average activity levels	Trajectory of the average steps per day registered by the Fitbit Inspire over time (decreasing, increasing, stable) for the periods between enrollment and stopping opioids, enrollment and pain resolution	From baseline up to 180 days
Treatment satisfaction	Patient-reported satisfaction with health care received to treat pain: distribution of responses. "Treatment satisfaction: In general, how satisfied are you with the health care you received to treat your pain? Very satisfied; Somewhat satisfied; Somewhat dissatisfied; Very dissatisfied"	From baseline up to 180 days
Barriers to treatment	Reported barriers to accessing additional treatment: proportion reporting difficulty with one or more of the following: getting a refill, difficulty getting a pharmacy to fill, getting insurance to pay for treatment, being able to afford to pay for treatment.	From baseline up to 180 days
Description of pain medications used	Use patterns of different pain medications (opioid and any combination ingredients), including the strength, and number of pills dispensed (in MME)	From baseline up to 180 days
Patient opioid use progression	Proportion of patients progressing to: long-term use of opioids (90+ days of use or 120+ days' supply filled)	From baseline up to 180 days
Patient chronic pain progression	Proportion of patients progressing to chronic pain (pain lasts 90+ days)	From baseline up to 180 days
Patient-Reported Outcomes Measurement Information System (PROMIS) Prescription Pain Medication Misuse short-form; selected items	We will assess this outcome with 5 survey items drawn from the Patient-Reported Outcomes Measurement Information System (PROMIS) Prescription Pain Medication Misuse short-form. The total score for these 5 items ranges from 5 to 25 with 25 signaling greatest misuse.	From baseline up to 180 days
Storage and disposal guidance	Proportion of patients that report receiving: information on how to properly dispose of medication, and/or on the importance of disposing of unused medication.	From baseline up to 180 days
Opioid Storage Methods	Proportion of patients that report storing opioids in: a locked location (proportion reporting always or almost always), a latched location (proportion reporting always or almost always), in the original bottle (proportion reporting always or almost always)	From baseline up to 180 days
Unused Opioids	Number of opioids left over after opioid discontinuation and estimated amount used during study period Measured in absolute amounts-e.g., mg of oxycodone-as well as MME and tablets	From baseline up to 180 days
Estimated Opioid Use	Based on left over opioids, amount used during study period Measured in absolute amounts-e.g., mg of oxycodone-as well as MME and tablets	From baseline up to 180 days
Opioid Disposal	Proportion of patients reporting each disposal method including disposing of drug in garbage, flushed down toilet, returned to police, returned to pharmacy, passed on to someone else, kept for future use/did not dispose, used up all opioids. Motivations for disposing of or keeping leftover drugs, proportion reporting each survey response.	From baseline up to 180 days
Motivations for disposing or keeping leftover drugs	We will assess this outcome with 16 survey items drawn from the University of South Florida and Purdue Pharma study of disposal. We will report on the proportion of participants endorsing each item. Representative items include inconvenience, risk of disposal, and potential need for opioids in the future	From baseline up to 180 days

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Joseph Ross, MD, MHS, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 2000027561; 2U01FD005938-03 (U.S. FDA Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes