Clinical trial NCT04509115: Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
Official title: Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Opioid Prescribing
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2020-08-11
Enrollment: 1709
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: This study will characterize patient pain and opioid use after an initial 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

Eligibility criteria: 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.

Primary outcomes:
measure: Opioid Pain medication use
timeFrame: From baseline up to 180 days
measure: Non-Opioid pain medication and treatment use
timeFrame: From baseline up to 180 days
measure: Pain medication use concordant with directions for use
timeFrame: From baseline up to 180 days
Secondary outcomes:
measure: Time to opioid discontinuation
timeFrame: From initial opioid use to the day on which the last opioid was taken, up to 180 days.
measure: Time to pain resolution
timeFrame: From baseline up to 180 days
measure: Average activity levels
timeFrame: From baseline up to 180 days
measure: Treatment satisfaction
timeFrame: From baseline up to 180 days
measure: Barriers to treatment
timeFrame: From baseline up to 180 days
measure: Description of pain medications used
timeFrame: From baseline up to 180 days
measure: Patient opioid use progression
timeFrame: From baseline up to 180 days
measure: Patient chronic pain progression
timeFrame: From baseline up to 180 days
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Prescription Pain Medication Misuse short-form; selected items
timeFrame: From baseline up to 180 days
measure: Storage and disposal guidance
timeFrame: From baseline up to 180 days
measure: Opioid Storage Methods
timeFrame: From baseline up to 180 days
measure: Unused Opioids
timeFrame: From baseline up to 180 days
measure: Estimated Opioid Use
timeFrame: From baseline up to 180 days
measure: Opioid Disposal
timeFrame: From baseline up to 180 days
measure: Motivations for disposing or keeping leftover drugs
timeFrame: From baseline up to 180 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: New Haven
country: United States
facility: Yale-New Haven Health
state: Connecticut
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rapid City
country: United States
facility: Monument Health
state: South Dakota
Study officials:
affiliation: Yale University
name: Joseph Ross, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.