- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03773484
Application of Economics & Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase (AESOPS)
February 9, 2023 updated by: Jason Doctor, University of Southern California
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- NM clinic that sees patients ≥ 18 years old whose leadership agrees to participate
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Clinical Decision Support
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Weekly Milligram Morphine Equivalent (MME)
Time Frame: 34 weeks
|
Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention
|
34 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 25, 2019
Primary Completion (ACTUAL)
November 30, 2019
Study Completion (ACTUAL)
November 30, 2019
Study Registration Dates
First Submitted
December 10, 2018
First Submitted That Met QC Criteria
December 10, 2018
First Posted (ACTUAL)
December 12, 2018
Study Record Updates
Last Update Posted (ESTIMATE)
February 14, 2023
Last Update Submitted That Met QC Criteria
February 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-CG-17-00019
- R21AG057395-01 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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