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| ID | Type | Description | Link |
|---|---|---|---|
| 2U01FD005938-03 | U.S. FDA Grant/Contract | View source |
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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Ross, MD, MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Cedars Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35790333 | Derived | 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. |
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| 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 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Yale-New Haven Health | New Haven | Connecticut | 06510 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Monument Health | Rapid City | South Dakota | 57701 | United States |