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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03773484
Other study ID # HS-CG-17-00019
Secondary ID R21AG057395-01
Status Completed
Phase N/A
First received
Last updated
Start date March 25, 2019
Est. completion date November 30, 2019

Study information

Verified date February 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date November 30, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - NM clinic that sees patients = 18 years old whose leadership agrees to participate Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Opioid naive
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
At-risk for long term use
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
Long-term opioid recipient
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

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (5)

Lead Sponsor Collaborator
University of Southern California AltaMed Health Services Corporation, National Institute on Aging (NIA), Northwestern University, The Children's Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kelley MA, Persell SD, Linder JA, Friedberg MW, Meeker D, Fox CR, Goldstein NJ, Knight TK, Zein D, Rowe TA, Sullivan MD, Doctor JN. The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety Trial 1 (AESOPS-1): Electronic health record nudges. Contemp Clin Trials. 2021 Apr;103:106329. doi: 10.1016/j.cct.2021.106329. Epub 2021 Feb 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Average Weekly Milligram Morphine Equivalent (MME) Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention 34 weeks
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