Opioid Abuse, UnspecifiedAESOPS-T1NCT04477304

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

A study testing Opioid Naive, OR, At-risk for long-term use, OR and Long-term opioid recipient in people with Opioid Abuse, Unspecified, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Abuse, Unspecified
What is being tested?: Opioid Naive, OR, At-risk for long-term use, OR and Long-term opioid recipient
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 555 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2020to 6 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: Electronic Health Record Nudges

Read the 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
Being tested: Opioid Naive, OR, At-risk for long-term use, OR, Long-term opioid recipient
Keywords: opioid use disorder, randomized control trial, behavioral economics, nudges
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Opioid Naive, ORBehavioural
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, ORBehavioural
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 recipientBehavioural
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

Study groups in NCT04477304
Study group	Role	What they receive
Behavioral Intervention Arm	Experimental	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. Receives: Behavioral: Opioid Naive, OR; Behavioral: At-risk for long-term use, OR; Behavioral: Long-term opioid recipient
Control	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs)
Change = (18-month intervention average of natural log MME summed per-clinician, per-week - 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)
Measured: 6-month baseline and 18-month intervention
Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)
Change = (18-month intervention average of natural log MME summed per-clinician, per-week - 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)
Measured: 6-month baseline and 18-month intervention

Secondary outcomes (1)

Change in Average Per-clinician Weekly Proportion of Chronic Patients Prescribed a High Dose Opioid (=> 50 MME Daily Dose Rxs) Between Baseline and Intervention
Change = (18-month intervention average per-clinician weekly proportion - 6-month baseline average per-clinician weekly proportion). Proportion = number of chronic patients who received Rx => 50 MME per-clinician, per-week/total patients who received opioid Rx per-clinician, per-week
Measured: 6-month baseline and 18-month intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20206 Aug 2023

First posted20 Jul 2020
Study start1 Dec 2020
Primary completion6 Aug 2023
Study completion6 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid Abuse, UnspecifiedStudies of the same condition, open and under way.
More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 555 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04477304
Sponsor's protocol ID: R33AG057395
Other IDs: R33AG057395
Acronym: AESOPS-T1
Status last verified: Jul 2025
First submitted: 14 Jul 2020
Last updated: 7 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 33636344

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: Electronic Health Record Nudges
ClinicalTrials.gov ID: NCT04477304
Acronym / sponsor ID: AESOPS-T1 / R33AG057395
Conditions: Opioid Abuse, Unspecified
Keywords: opioid use disorder, randomized control trial, behavioral economics, nudges
Study type: Interventional
Recruitment status: Completed
Enrolment: 555 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Collaborators: Northwestern University, AltaMed Health Services Corporation, National Institute on Aging (NIA)
Study start: 1 Dec 2020 (actual)
Primary completion: 6 Aug 2023 (actual)
Study completion: 6 Aug 2023 (actual)
First posted: 20 Jul 2020 (actual)
Results: Posted 6 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Behavioral Intervention Arm	Experimental	Behavioral: Opioid Naive, OR, Behavioral: At-risk for long-term use, OR, Behavioral: Long-term opioid recipientClinicians 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.
Control	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Opioid Naive, ORVisits 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	Behavioural	Behavioral Intervention Arm
At-risk for long-term use, ORVisit 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	Behavioural	Behavioral Intervention Arm
Long-term opioid recipientTotal 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	Behavioural	Behavioral Intervention Arm

Primary outcome

Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs)
Time frame: 6-month baseline and 18-month intervention
Change = (18-month intervention average of natural log MME summed per-clinician, per-week - 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)
Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)
Time frame: 6-month baseline and 18-month intervention
Change = (18-month intervention average of natural log MME summed per-clinician, per-week - 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)

1 secondary outcome

Change in Average Per-clinician Weekly Proportion of Chronic Patients Prescribed a High Dose Opioid (=> 50 MME Daily Dose Rxs) Between Baseline and Intervention
Time frame: 6-month baseline and 18-month intervention

Results and safety

Results posted to the registry on 6 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Behavioral Intervention Arm	322	275
Control	233	207

Primary outcome: Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs)

Time frame: 6-month baseline and 18-month intervention. Mean (Standard Deviation). Unit: chg in avg per-clin log total weekly MME

Measure	Behavioral Intervention Arm n = 275	Control n = 207
Value	-0.14 (0.01)	-0.05 (0.01)

Behavioral Intervention Arm vs Control: Mean Difference (Net): -0.09 (95% CI -0.12 to -0.07), p <0.001, Mixed Models Analysis

Population analysed: Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx \< 50 MME during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.

Primary outcome: Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)

Time frame: 6-month baseline and 18-month intervention. Mean (Standard Deviation). Unit: chg in avg per-clin log total weekly MME

Measure	Behavioral Intervention Arm n = 185	Control n = 129
Value	-0.21 (0.02)	-0.02 (0.01)

Behavioral Intervention Arm vs Control: Mean Difference (Net): -0.19 (95% CI -0.23 to -0.16), p <0.001, Mixed Models Analysis

Population analysed: Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx =\> 50 MME during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 18 month intervention period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Behavioral Intervention Arm	0 of 322 (0%)	0 of 322 (0%)	0 of 322
Control	0 of 233 (0%)	0 of 233 (0%)	0 of 233

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33636344Kelley 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.
Related InfoLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason N Doctor, PhD principal investigator

University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs) (time frame: 6-month baseline and 18-month intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04477304, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.