Application of Economics & Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase

NCT ID: NCT03773484

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2019-11-30

Brief Summary

There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. The objective of the R21 pilot phase of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain. Interventions will leverage the electronic health record (EHR) to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.

Detailed Description

There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. In 2017, the Centers for Disease Control and Prevention (CDC) issued the "CDC Guideline for Prescribing Opioids for Chronic Pain" to encourage safe and effective alternatives to opioids, discontinuation of opioids when patients do not resume normal activities and prudent dosing strategies. However, poor guideline adherence is a general concern and may impede uptake. Our prior studies have used insights from behavioral economics and social psychology to increase guideline adherence. The objective of the R21 pilot phase of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain. At the time of opioid prescribing, clinicians 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. The primary outcome is average weekly morphine milligram equivalents (MME) prescribed per-clinician.

Conditions

Opioid Use, Unspecified

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Clinical Decision Support

Clinical decision support nudges within the electronic health record to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice. Participating clinicians will receive any of three nudges when eligibility criteria are met within a patient's chart.

Group Type: EXPERIMENTAL

Opioid naive

Intervention Type: BEHAVIORAL

Visit 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

At-risk for long term use

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

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

Interventions

Opioid naive

Visit 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

Intervention Type: BEHAVIORAL

At-risk for long term use

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

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• NM clinic that sees patients ≥ 18 years old whose leadership agrees to participate

Exclusion Criteria

• None

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

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

AltaMed Health Services Corporation

OTHER

Sponsor Role: collaborator

The Children's Clinic

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Jason Doctor

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

Other Identifiers

R21AG057395-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS-CG-17-00019

Identifier Type: -

Identifier Source: org_study_id