Opioid UseNCT04509115
Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
An observational study of Opioid Use and Opioid Prescribing, run by Yale University at 5 sites in United States.
Trial summary
This study will characterize patient pain and opioid use after an initial opioid prescription for acute pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioid Prescribing
- What is being tested?
- Short-acting opioid prescription for acute pain
- How many people
- 1,709 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Sep 2020to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama Birmingham
Birmingham, Alabama, 35233
Cedars Sinai
Los Angeles, California, 90048
Yale-New Haven Health
New Haven, Connecticut, 06510
Monument Health
Rapid City, South Dakota, 57701
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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
- 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
- Conditions
- Opioid Use, Opioid Prescribing
- Being tested
- Short-acting opioid prescription for acute pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Short-acting opioid prescription for acute pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Pain medication use
Number of days using any opioid medications
Measured: From baseline up to 180 days
Non-Opioid pain medication and treatment use
Number of days using any non-opioid drugs/treatments
Measured: 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.
Measured: From baseline up to 180 days
Secondary outcomes (15)
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.
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).
Measured: 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
Measured: 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"
Measured: 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.
Measured: 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)
Measured: 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)
Measured: From baseline up to 180 days
Patient chronic pain progression
Proportion of patients progressing to chronic pain (pain lasts 90+ days)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: From baseline up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start11 Sep 2020
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,709 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Joseph Ross, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509115
- Sponsor's protocol ID
- 2000027561
- Other IDs
- 2U01FD005938-03
- Status last verified
- Dec 2023
- First submitted
- 7 Aug 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 35790333
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
- ClinicalTrials.gov ID
- NCT04509115
- Acronym / sponsor ID
- 2000027561
- Conditions
- Opioid Use, Opioid Prescribing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,709 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients given short-acting opioid prescription | – | Drug: Short-acting opioid prescription for acute painPatients not currently using opioids who receive a new short-acting opioid prescription for acute pain will be recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-acting opioid prescription for acute painPatients 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. | Drug | Patients given short-acting opioid prescription |
Primary outcome
Opioid Pain medication use
Time frame: From baseline up to 180 days
Number of days using any opioid medications
Non-Opioid pain medication and treatment use
Time frame: From baseline up to 180 days
Number of days using any non-opioid drugs/treatments
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.
15 secondary outcomes
Time to opioid discontinuation
Time frame: From initial opioid use to the day on which the last opioid was taken, up to 180 days.
Time to pain resolution
Time frame: From baseline up to 180 days
Average activity levels
Time frame: From baseline up to 180 days
Treatment satisfaction
Time frame: From baseline up to 180 days
Barriers to treatment
Time frame: From baseline up to 180 days
Description of pain medications used
Time frame: From baseline up to 180 days
Patient opioid use progression
Time frame: From baseline up to 180 days
Patient chronic pain progression
Time frame: From baseline up to 180 days
Patient-Reported Outcomes Measurement Information System (PROMIS) Prescription Pain Medication Misuse short-form; selected items
Time frame: From baseline up to 180 days
Storage and disposal guidance
Time frame: From baseline up to 180 days
Opioid Storage Methods
Time frame: From baseline up to 180 days
Unused Opioids
Time frame: From baseline up to 180 days
Estimated Opioid Use
Time frame: From baseline up to 180 days
Opioid Disposal
Time frame: From baseline up to 180 days
Motivations for disposing or keeping leftover drugs
Time frame: From baseline up to 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 35790333Jeffery 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Ross, MD, MHS principal investigator
Yale University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Opioid Prescribing, run by Yale University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Pain medication use (time frame: From baseline up to 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.