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

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ClinicalTrials.gov Identifier: NCT04477304
Recruitment Status : Completed
First Posted : July 20, 2020
Last Update Posted : September 26, 2023
Sponsor:
Collaborators:
Northwestern University
AltaMed Health Services Corporation
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jason Doctor, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Opioid Abuse, Unspecified Behavioral: Opioid Naive, OR Behavioral: At-risk for long-term use, OR Behavioral: Long-term opioid recipient Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: Electronic Health Record Nudges
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : February 6, 2023
Actual Study Completion Date : August 6, 2023

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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

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

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

No Intervention: 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.



Primary Outcome Measures :
  1. Change in clinician aggregate weekly milligram morphine equivalents (MME) [ Time Frame: 18 months ]
    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 :
  1. Change in proportion of patients prescribed opioids of > 50 MME/day [ Time Frame: 18 months ]
    We will evaluate the proportion of dosages that equal or exceed 50 MME per day


Other Outcome Measures:
  1. Change in clinician aggregate weekly milligram morphine equivalents (MME) [ Time Frame: 19-24 months ]
    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.

  2. Change in proportion of patients prescribed opioids of > 50 MME/day [ Time Frame: 19-24 months ]
    We will evaluate the proportion of dosages that equal or exceed 50 MME per day



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477304


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
University of Southern California
Northwestern University
AltaMed Health Services Corporation
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jason N Doctor, PhD University of Southern California
Publications:
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Responsible Party: Jason Doctor, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT04477304    
Other Study ID Numbers: R33AG057395 ( U.S. NIH Grant/Contract )
R33AG057395 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Doctor, University of Southern California:
opioid use disorder
randomized control trial
behavioral economics
nudges
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents