<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477304</url>
  </required_header>
  <id_info>
    <org_study_id>R33AG057395</org_study_id>
    <secondary_id>R33AG057395</secondary_id>
    <nct_id>NCT04477304</nct_id>
  </id_info>
  <brief_title>Application of Economics &amp; Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges</brief_title>
  <acronym>AESOPS-T1</acronym>
  <official_title>Application of Economics &amp; Social Psychology to Improve Opioid Prescribing Safety Trial 1: Electronic Health Record Nudges</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AltaMed Health Services Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The opioid epidemic has had a tremendous negative impact on the health of persons in the U.S.&#xD;
      The objective of the trial 1 of Application of Economics &amp; Social psychology to improve&#xD;
      Opioid Prescribing Safety (AESOPS-T1), is to discourage unnecessary opioid prescribing&#xD;
      through the application of &quot;behavioral insights&quot;-empirically-tested social and psychological&#xD;
      interventions that affect choice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multisite study, AESOPS-T1 randomizes clinics to behavioral intervention or control.&#xD;
      Clinics randomized to the behavioral intervention arm receive electronic health record&#xD;
      (EHR)-based nudges. Eligible participants are clinicians who practice ambulatory primary care&#xD;
      at the participating clinical sites in Illinois and California. At the time of opioid&#xD;
      prescribing, clinicians in clinics randomized to the intervention group will be prompted with&#xD;
      an EHR nudge when the prescribing history for the patient falls into one of the following&#xD;
      three mutually exclusive categories: Opioid naïve, At-risk for long-term use, or Long-term&#xD;
      opioid recipient. These EHR-based nudges include accountable justification, defaults and&#xD;
      precommitments. The control arm receives no EHR-based intervention. Both arms receive&#xD;
      guideline education. The primary outcome is the change in clinician aggregate weekly&#xD;
      milligram morphine equivalent (MME) dose and the secondary outcome is the proportion of&#xD;
      dosages that equal or exceed 50 MME per day. These outcomes will be estimated by treatment&#xD;
      arm with an intent-to-treat difference-in-differences framework using a mixed-effects&#xD;
      regression model on clinician MME daily dose. The intervention period will be 18-months, with&#xD;
      a 6-month follow-up period to measure the persistence of effects after the interventions&#xD;
      conclude.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">August 6, 2023</completion_date>
  <primary_completion_date type="Actual">February 6, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in clinician aggregate weekly milligram morphine equivalents (MME)</measure>
    <time_frame>18 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in proportion of patients prescribed opioids of &gt; 50 MME/day</measure>
    <time_frame>18 months</time_frame>
    <description>We will evaluate the proportion of dosages that equal or exceed 50 MME per day</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in clinician aggregate weekly milligram morphine equivalents (MME)</measure>
    <time_frame>19-24 months</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in proportion of patients prescribed opioids of &gt; 50 MME/day</measure>
    <time_frame>19-24 months</time_frame>
    <description>We will evaluate the proportion of dosages that equal or exceed 50 MME per day</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">555</enrollment>
  <condition>Opioid Abuse, Unspecified</condition>
  <arm_group>
    <arm_group_label>Behavioral Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Opioid Naive, OR</intervention_name>
    <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</description>
    <arm_group_label>Behavioral Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>At-risk for long-term use, OR</intervention_name>
    <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</description>
    <arm_group_label>Behavioral Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Long-term opioid recipient</intervention_name>
    <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</description>
    <arm_group_label>Behavioral Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Providers of clinics that see patients ≥ 18 years old and for whom clinic leadership&#xD;
             agrees to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visits will be excluded from intervention when the patient has active cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason N Doctor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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 &amp; 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.</citation>
    <PMID>33636344</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Jason Doctor</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>opioid use disorder</keyword>
  <keyword>randomized control trial</keyword>
  <keyword>behavioral economics</keyword>
  <keyword>nudges</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477304
org study id: R33AG057395
secondary id: R33AG057395
nct id: NCT04477304
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in clinician aggregate weekly milligram morphine equivalents (MME)
time frame: 18 months
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.
measure: Change in proportion of patients prescribed opioids of > 50 MME/day
time frame: 18 months
description: We will evaluate the proportion of dosages that equal or exceed 50 MME per day
measure: Change in clinician aggregate weekly milligram morphine equivalents (MME)
time frame: 19-24 months
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.
measure: Change in proportion of patients prescribed opioids of > 50 MME/day
time frame: 19-24 months
description: We will evaluate the proportion of dosages that equal or exceed 50 MME per day
arm group label: Behavioral Intervention Arm
arm group type: Experimental
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 group label: Control
arm group type: No Intervention
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: Opioid Naive, OR
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
arm group label: Behavioral Intervention Arm
intervention type: Behavioral
intervention name: At-risk for long-term use, OR
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
arm group label: Behavioral Intervention Arm
intervention type: Behavioral
intervention name: Long-term opioid recipient
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
arm group label: Behavioral Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason N Doctor, PhD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
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.
PMID: 33636344
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Jason Doctor
investigator title: Associate Professor
mesh term: Opioid-Related Disorders
mesh term: Analgesics, Opioid