Skip to main content
OpenTrials
Completed

NCT Number: NCT04509115

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Use Opioid Prescribing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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

  • 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
  • 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
  • To assess how patients handled unused opioids

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Short-acting opioid prescription for acute pain

Drug

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.

Primary outcomes

  1. Opioid Pain medication use

    Time frame: From baseline up to 180 days

    Number of days using any opioid medications

  2. Non-Opioid pain medication and treatment use

    Time frame: From baseline up to 180 days

    Number of days using any non-opioid drugs/treatments

  3. Pain medication use concordant with directions for use

    Time frame: From baseline up to 180 days

    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.

Secondary outcomes

  1. Time to opioid discontinuation

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

    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.

  2. Time to pain resolution

    Time frame: From baseline up to 180 days

    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).

  3. Average activity levels

    Time frame: From baseline up to 180 days

    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

  4. Treatment satisfaction

    Time frame: From baseline up to 180 days

    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"

  5. Barriers to treatment

    Time frame: From baseline up to 180 days

    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.

  6. Description of pain medications used

    Time frame: From baseline up to 180 days

    Use patterns of different pain medications (opioid and any combination ingredients), including the strength, and number of pills dispensed (in MME)

  7. Patient opioid use progression

    Time frame: From baseline up to 180 days

    Proportion of patients progressing to: long-term use of opioids (90+ days of use or 120+ days' supply filled)

  8. Patient chronic pain progression

    Time frame: From baseline up to 180 days

    Proportion of patients progressing to chronic pain (pain lasts 90+ days)

  9. Patient-Reported Outcomes Measurement Information System (PROMIS) Prescription Pain Medication Misuse short-form; selected items

    Time frame: From baseline up to 180 days

    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.

  10. Storage and disposal guidance

    Time frame: From baseline up to 180 days

    Proportion of patients that report receiving: information on how to properly dispose of medication, and/or on the importance of disposing of unused medication.

  11. Opioid Storage Methods

    Time frame: From baseline up to 180 days

    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)

  12. Unused Opioids

    Time frame: From baseline up to 180 days

    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

  13. Estimated Opioid Use

    Time frame: From baseline up to 180 days

    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

  14. Opioid Disposal

    Time frame: From baseline up to 180 days

    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.

  15. Motivations for disposing or keeping leftover drugs

    Time frame: From baseline up to 180 days

    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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2020
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.