Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges

NCT ID: NCT04477304

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 555 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-08-06

Brief Summary

The opioid epidemic has had a tremendous negative impact on the health of persons in the U.S. The objective of the trial 1 of Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-T1), is to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.

Detailed Description

A multisite study, AESOPS-T1 randomizes clinics to behavioral intervention or control. Clinics randomized to the behavioral intervention arm receive electronic health record (EHR)-based nudges. Eligible participants are clinicians who practice ambulatory primary care at the participating clinical sites in Illinois and California. At the time of opioid prescribing, clinicians in clinics randomized to the intervention group will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three mutually exclusive categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient. These EHR-based nudges include accountable justification, defaults and precommitments. The control arm receives no EHR-based intervention. Both arms receive guideline education. The primary outcome is the change in clinician aggregate weekly milligram morphine equivalent (MME) dose and the secondary outcome is the proportion of dosages that equal or exceed 50 MME per day. These outcomes will be estimated by treatment arm with an intent-to-treat difference-in-differences framework using a mixed-effects regression model on clinician MME daily dose. The intervention period will be 18-months, with a 6-month follow-up period to measure the persistence of effects after the interventions conclude.

Conditions

Opioid Abuse, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Behavioral Intervention Arm

Clinicians in clinics randomized to the intervention group will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient. These EHR-based nudges include elements of accountable justification, defaults and precommitments. Clinicians will also receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.

Group Type: EXPERIMENTAL

Opioid Naive, OR

Intervention Type: BEHAVIORAL

Visits where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days and clinician is on the clinic list as a treating member of the clinic

At-risk for long-term use, OR

Intervention Type: BEHAVIORAL

Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days and clinician is on the clinic list as a treating member of the clinic

Long-term opioid recipient

Intervention Type: BEHAVIORAL

Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days and clinician is on the clinic list as a treating member of the clinic

Control

Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Opioid Naive, OR

Visits where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days and clinician is on the clinic list as a treating member of the clinic

Intervention Type: BEHAVIORAL

At-risk for long-term use, OR

Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days and clinician is on the clinic list as a treating member of the clinic

Intervention Type: BEHAVIORAL

Long-term opioid recipient

Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days and clinician is on the clinic list as a treating member of the clinic

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Providers of clinics that see patients ≥ 18 years old and for whom clinic leadership agrees to participate.

Exclusion Criteria

• Visits will be excluded from intervention when the patient has active cancer.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

AltaMed Health Services Corporation

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Jason Doctor

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason N Doctor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

Kelley MA, Persell SD, Linder JA, Friedberg MW, Meeker D, Fox CR, Goldstein NJ, Knight TK, Zein D, Rowe TA, Sullivan MD, Doctor JN. The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety Trial 1 (AESOPS-1): Electronic health record nudges. Contemp Clin Trials. 2021 Apr;103:106329. doi: 10.1016/j.cct.2021.106329. Epub 2021 Feb 24.

Reference Type: BACKGROUND

PMID: 33636344 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://doi.org/10.1016/j.cct.2021.106329

Related Info

Other Identifiers

R33AG057395

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R33AG057395

Identifier Type: NIH

Identifier Source: org_study_id

View Link