Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges

Opioid Abuse, Unspecified Clinical Trial

— AESOPS-T1  

Official title:

Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: Electronic Health Record Nudges

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477304
• Other study ID #: R33AG057395
• Secondary ID: R33AG057395
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: August 6, 2023

Study information

• Verified date: June 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The opioid epidemic has had a tremendous negative impact on the health of persons in the U.S. The objective of the trial 1 of Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-T1), is to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.

Description:

A multisite study, AESOPS-T1 randomizes clinics to behavioral intervention or control. Clinics randomized to the behavioral intervention arm receive electronic health record (EHR)-based nudges. Eligible participants are clinicians who practice ambulatory primary care at the participating clinical sites in Illinois and California. At the time of opioid prescribing, clinicians in clinics randomized to the intervention group 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. These EHR-based nudges include accountable justification, defaults and precommitments. The control arm receives no EHR-based intervention. Both arms receive guideline education. The primary outcome is the change in clinician aggregate weekly milligram morphine equivalent (MME) dose and the secondary outcome is the proportion of dosages that equal or exceed 50 MME per day. These outcomes will be estimated by treatment arm with an intent-to-treat difference-in-differences framework using a mixed-effects regression model on clinician MME daily dose. The intervention period will be 18-months, with a 6-month follow-up period to measure the persistence of effects after the interventions conclude.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: August 6, 2023
• Est. primary completion date: August 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Providers of clinics that see patients = 18 years old and for whom clinic leadership agrees to participate.

Exclusion Criteria:

• Visits will be excluded from intervention when the patient has active cancer.

Related Conditions & MeSH terms

• Opioid Abuse, Unspecified
• Opioid-Related Disorders

Intervention

Behavioral:
• Opioid Naive, OR
Visits 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 and clinician is on the clinic list as a treating member of the clinic
• At-risk for long-term use, OR
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 and clinician is on the clinic list as a treating member of the clinic
• 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 and clinician is on the clinic list as a treating member of the clinic

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (4)

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

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
Other	Change in clinician aggregate weekly milligram morphine equivalents (MME)	Change in clinician aggregate weekly MME will be evaluated separately for two groups: (i) 50 MME and above, and (ii) below 50 MME daily dose orders.	19-24 months
Other	Change in proportion of patients prescribed opioids of > 50 MME/day	We will evaluate the proportion of dosages that equal or exceed 50 MME per day	19-24 months
Primary	Change in clinician aggregate weekly milligram morphine equivalents (MME)	Change in clinician aggregate weekly MME will be evaluated separately for two groups: (i) 50 MME and above, and (ii) below 50 MME daily dose orders.	18 months
Secondary	Change in proportion of patients prescribed opioids of > 50 MME/day	We will evaluate the proportion of dosages that equal or exceed 50 MME per day	18 months