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

NCT04758637 | Completed Results DMC

• 2 other identifiers: UP-20-01330R33AG057395
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Abuse

Keywords

opioid use disorder; randomized control trial; behavioral economics; nudges

Outcome Measures

Primary Outcomes (1)

• Change in Daily Average Number of 5 MME Pill Counts

  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 Outcomes (1)

• Change in Clinician-level, Pre-to-post Mean Proportion of High Dose (=> 50 MME) Patient Visits

  13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)

Study Arms (2)

Control Group

NO INTERVENTION

Physicians in the control group will receive no notification of their patient's fatal or nonfatal overdose.

Overdose Notification Group

EXPERIMENTAL

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

Interventions

Overdose Notification BEHAVIORAL

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.

Overdose Notification Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• Prescriptions to patients in hospice or with active cancer

Sponsors & Collaborators

• University of Southern California: lead
• Northwestern University: collaborator
• AltaMed Health Services Corporation: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Kelley MA, Persell SD, Linder JA, Friedberg MW, Meeker D, Fox CR, Goldstein NJ, Knight TK, Zein D, Sullivan MD, Doctor JN. The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety trial 2 (AESOPS-2): Availability of opioid harm. Contemp Clin Trials. 2022 Jan;112:106650. doi: 10.1016/j.cct.2021.106650. Epub 2021 Dec 8.

  PMID: 34896295 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Jason Doctor
• Organization: University of Southern California

jdoctor@usc.edu

213.821.8142

Study Officials

• Jason Doctor, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: January 23, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: October 7, 2025
• Results First Posted: October 7, 2025

Record last verified: 2025-09

Locations

US (1)