An observational study in Opioid Use and Opioid Prescribing, sponsored by Yale University. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Yale University · Observational
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
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 1,709 is above the median of 150 across 113 observational studies indexed under Acute Pain.
Browse Acute Pain studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
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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.
Exclusion Criteria:
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.
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
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
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
Time frame: 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"
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: From baseline up to 180 days
Patient chronic pain progression
Proportion of patients progressing to chronic pain (pain lasts 90+ days)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: From baseline up to 180 days
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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