An interventional study of Opioid naive and At-risk for long term use in Opioid Use, Unspecified, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by University of Southern California · Not applicable, Interventional, and Health services research
There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. The objective of the R21 pilot phase of the Application of Economics \& Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain. Interventions will leverage the electronic health record (EHR) to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.
There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. In 2017, the Centers for Disease Control and Prevention (CDC) issued the "CDC Guideline for Prescribing Opioids for Chronic Pain" to encourage safe and effective alternatives to opioids, discontinuation of opioids when patients do not resume normal activities and prudent dosing strategies. However, poor guideline adherence is a general concern and may impede uptake. Our prior studies have used insights from behavioral economics and social psychology to increase guideline adherence. The objective of the R21 pilot phase of the Application of Economics \& Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain. At the time of opioid prescribing, clinicians will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three mutually exclusive categories: Opioid naïve, At-risk for long term use, or Long-term opioid recipient. The primary outcome is average weekly morphine milligram equivalents (MME) prescribed per-clinician.
University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical decision support nudges within the electronic health record to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice. Participating clinicians will receive any of three nudges when eligibility criteria are met within a patient's chart.
Behavioral: Opioid naive · Behavioral: At-risk for long term use · Behavioral: Long-term opioid recipient
Visit where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days
Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days
Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days
Average Weekly Milligram Morphine Equivalent (MME)
Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention
Time frame: 34 weeks
41 primary care clinicians from 3 clinics at Northwestern Medicine in Chicago, Illinois were enrolled.
| Milestone | Clinical Decision Support Nudges |
|---|---|
| Started | 41 |
| Completed | 41 |
| Not completed | 0 |
| Milestone | Clinical Decision Support Nudges |
|---|---|
| Started | 41 |
| Completed | 36 |
| Not completed | 5 |
| Withdrew: 5 clinicians were excluded from analysis due to lack of prescribing data | 5 |
Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention
| Weekly MME per clinician | Clinical Decision Support Nudges |
|---|---|
| Opioid naïve | 34.62 ± 97.13 |
| At-risk for long term use | 22.37 ± 102.67 |
| Long-term opioid recipient | NA ± NA |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clinical Decision Support Nudges | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
41 clinicians from 3 Northwestern Medicine clinics were enrolled
| Age, Categorical(Participants) | Clinical Decision Support |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 33 |
| >=65 years | 8 |
| Sex: Female, Male(Participants) | Clinical Decision Support |
|---|---|
| Female | 26 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | Clinical Decision Support |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 41 |
| Race and Ethnicity Not Collected(Participants) | Clinical Decision Support |
|---|
| Region of Enrollment(participants) | Clinical Decision Support |
|---|---|
| United States | 41 |
| Average weekly milligram morphine equivalent (MME)(Weekly MME) | Clinical Decision Support |
|---|---|
| Opioid naive | 34.88 ± 86.07 |
| At risk for long term use | 34.44 ± 168.03 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Southern California