NCT03773484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 16, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

December 10, 2018

Results QC Date

July 7, 2021

Last Update Submit

February 9, 2023

Conditions

Opioid Use, Unspecified

Keywords

OpioidsBehavioral Research

Outcome Measures

Primary Outcomes (1)

  • Average Weekly Milligram Morphine Equivalent (MME)

    Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention

    34 weeks

Study Arms (1)

Clinical Decision Support

EXPERIMENTAL

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.

Behavioral: Opioid naiveBehavioral: At-risk for long term useBehavioral: Long-term opioid recipient

Interventions

Opioid naiveBEHAVIORAL

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

Clinical Decision Support
At-risk for long term useBEHAVIORAL

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

Clinical Decision Support
Long-term opioid recipientBEHAVIORAL

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

Clinical Decision Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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.

    PMID: 33636344BACKGROUND

Results Point of Contact

Title
Dr. Jason Doctor
Organization
University of Southern California
jdoctor@usc.edu
213-821-8142

Study Officials

  • Jason N Doctor, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 12, 2018

Study Start

March 25, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

February 14, 2023

Results First Posted

August 16, 2022

Record last verified: 2023-02

Locations

US(1)