Clinical trial NCT04758637: AESOPS Trial 2 (AESOPS-2): Availability of Opioid Harm
Official title: Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 2 (AESOPS-2): Availability of Opioid Harm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Abuse
Keywords: opioid use disorder
randomized control trial
behavioral economics
nudges
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: AltaMed Health Services Corporation
name: National Institute on Aging (NIA)
First posted: 2021-02-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Weekly MME
timeFrame: 13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)
Secondary outcomes:
measure: Change in the Proportion of Patients Prescribed at least 50 Daily MME
timeFrame: 13 months (6 months pre-intervention, 30-day washout period, 6 months post-intervention)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: University of Southern California
name: Jason Doctor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.