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

Opioid Abuse Clinical Trial

— AESOPS-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04758637
• Other study ID #: UP-20-01330
• Secondary ID: R33AG057395
• Status: Completed
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: February 18, 2024

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 18, 2024
• Est. primary completion date: February 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Abuse
• Opioid-Related Disorders

Intervention

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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weekly MME	The primary outcome is the change in weekly morphine milligram equivalent (MME) ordered by clinicians pre- and post- letter intervention.	13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)
Secondary	Change in the Proportion of Patients Prescribed at least 50 Daily MME	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.	13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)