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

Not Applicable

Completed

• Conditions: Opioid Abuse
• Interventions: Behavioral: Overdose Notification

• Registration Number: NCT04758637
• Lead Sponsor: University of Southern California

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.

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 Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Study Start: 2023-01-23
• Primary Completion: 2024-03-18
• Study Completion: 2024-03-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Overdose Notification Group	Overdose Notification	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.

Primary Outcome Measures

Name	Time	Method
Change in Weekly MME	13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)	The primary outcome is the change in weekly morphine milligram equivalent (MME) ordered by clinicians pre- and post- letter intervention.

Secondary Outcome Measures

Name	Time	Method
Change in the Proportion of Patients Prescribed at least 50 Daily MME	13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)	The change in the proportion of patients on at least 50 MME/day between the pre- and post-period will be measured as the number of patient visits in which a prescription of at least 50 MME/day was written by that clinician in that 6-month period in the numerator and the number of patient visits involving an opioid prescription written by that clinician in that 6-month time period as the denominator. The difference between these proportions from the pre- to post-period will be quantified using logistic regression.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States