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Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges (AESOPS-T1)

Primary Purpose

Opioid Abuse, Unspecified

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid Naive, OR
At-risk for long-term use, OR
Long-term opioid recipient
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Abuse, Unspecified focused on measuring opioid use disorder, randomized control trial, behavioral economics, nudges

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral Intervention Arm

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in clinician aggregate weekly milligram morphine equivalents (MME)
Change in clinician aggregate weekly MME will be evaluated separately for two groups: (i) 50 MME and above, and (ii) below 50 MME daily dose orders.

Secondary Outcome Measures

Change in proportion of patients prescribed opioids of > 50 MME/day
We will evaluate the proportion of dosages that equal or exceed 50 MME per day

Full Information

First Posted
July 14, 2020
Last Updated
September 25, 2023
Sponsor
University of Southern California
Collaborators
Northwestern University, AltaMed Health Services Corporation, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04477304
Brief Title
Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges
Acronym
AESOPS-T1
Official Title
Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: Electronic Health Record Nudges
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
August 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Northwestern University, AltaMed Health Services Corporation, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Abuse, Unspecified
Keywords
opioid use disorder, randomized control trial, behavioral economics, nudges

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
555 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Opioid Naive, OR
Intervention Description
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
Intervention Name(s)
At-risk for long-term use, OR
Intervention Description
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
Intervention Name(s)
Long-term opioid recipient
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in clinician aggregate weekly milligram morphine equivalents (MME)
Description
Change in clinician aggregate weekly MME will be evaluated separately for two groups: (i) 50 MME and above, and (ii) below 50 MME daily dose orders.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in proportion of patients prescribed opioids of > 50 MME/day
Description
We will evaluate the proportion of dosages that equal or exceed 50 MME per day
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Change in clinician aggregate weekly milligram morphine equivalents (MME)
Description
Change in clinician aggregate weekly MME will be evaluated separately for two groups: (i) 50 MME and above, and (ii) below 50 MME daily dose orders.
Time Frame
19-24 months
Title
Change in proportion of patients prescribed opioids of > 50 MME/day
Description
We will evaluate the proportion of dosages that equal or exceed 50 MME per day
Time Frame
19-24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason N Doctor, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33636344
Citation
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.
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Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges

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