AESOPS Trial 2 (AESOPS-2): Availability of Opioid Harm (AESOPS-2)

September 18, 2025 updated by: Jason Doctor, University of Southern California

Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 2 (AESOPS-2): Availability of Opioid Harm

The opioid epidemic is the largest man-made public health crisis the United States has faced. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) study, is to discourage unnecessary opioid prescribing by increasing the salience of negative patient outcomes associated with opioid use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In AESOPS-2, a multi-site study, random assignment determines if prescribers to persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual-care (control). The AESOPS-2 trial will take place in 3 diverse health systems in the U.S. - Northwestern Medicine, AltaMed Health Services, and The Children's Clinic. At Northwestern Medicine, clinicians in the intervention group receive a letter notifying them of their patient's fatal or nonfatal ED overdose. At AltaMed Health Services, and The Children's Clinic, clinicians in the intervention group receive a letter notifying them of their patient's nonfatal ED overdose. The primary outcome is the change in clinician weekly milligram morphine equivalent (MME) dose prescribed in 6-month periods before and after receiving the letter. The secondary outcome is the change in the proportion of patients prescribed at least 50 daily MME. Group differences in these outcomes will be compared using an intent-to-treat difference-in-differences framework with a mixed-effects regression model to estimate clinician MME weekly dose. The AESOPS-2 trial will provide new knowledge about whether increasing prescribers' awareness of patients' opioid-related overdoses leads to a reduction in opioid prescribing. Additionally, this trial may better inform how to reduce opioid use disorder and opioid overdoses by lowering unnecessary population exposure to these drugs.

Study Type

Interventional

Enrollment (Actual)

61

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

  • United States
    • 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

Description

Inclusion Criteria:

  • 1) The clinician prescribed a qualifying scheduled drug to a patient in the 12 months prior to their non-fatal or fatal overdose 2) the patient is 18 years old or older at the time of the overdose, 3) the provider practices within a health system enrolled in the study, and 4) the overdose occurs during the 12-month observation period. Qualifying prescriptions include those for one of the following scheduled drugs: opioids, benzodiazepines, muscle relaxants or sedative-hypnotics.

Exclusion Criteria:

  • Prescriptions to patients in hospice or with active cancer

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Physicians in the control group will receive no notification of their patient's fatal or nonfatal overdose.
Experimental: Overdose Notification Group
The overdose notifications will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses.
Behavioral: Overdose Notification
We will identify overdoses from state vital records and insurance claims data linked to emergency departments. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a non-fatal or fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the deceased or surviving patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Daily Average Number of 5 MME Pill Counts
Time Frame: 13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)
The primary outcome is the change in daily average number of 5 morphine milligram equivalent (MME) pill counts ordered by clinicians during the last week of baseline (week 26) and the last week of the intervention period (week 53) letter intervention.
13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinician-level, Pre-to-post Mean Proportion of High Dose (=> 50 MME) Patient Visits
Time Frame: 13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)
The change in the clinician-level, pre-to-post mean proportion of high dose (=> 50 MME) patient visits by study arm. The numerator is whether a patient visit was => 50 MME, and the denominator is the number of opioids. We quantified this measure using logistic regression. Higher dose prescriptions are not recommended and are associated with the potential for greater patient harm.
13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Northwestern University
National Institute on Aging (NIA)
AltaMed Health Services Corporation

Investigators

  • Principal Investigator: Jason Doctor, PhD, University of Southern California

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.

General Publications

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)

January 23, 2023

Primary Completion (Actual)

March 18, 2024

Study Completion (Actual)

March 18, 2024

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP-20-01330
  • R33AG057395 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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