<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/NCT03773484</url>
  </required_header>
  <id_info>
    <org_study_id>HS-CG-17-00019</org_study_id>
    <secondary_id>R21AG057395-01</secondary_id>
    <nct_id>NCT03773484</nct_id>
  </id_info>
  <brief_title>Application of Economics &amp; Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase</brief_title>
  <acronym>AESOPS</acronym>
  <official_title>Application of Economics &amp; Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <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>The Children's Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</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>
      There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and&#xD;
      an abundance of evidence of harm. The objective of the R21 pilot phase of the Application of&#xD;
      Economics &amp; Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and&#xD;
      test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid&#xD;
      prescribing for persons with noncancer pain. Interventions will leverage the electronic&#xD;
      health record (EHR) to discourage unnecessary opioid prescribing through the application of&#xD;
      &quot;behavioral insights&quot;-empirically-tested social and psychological interventions that affect&#xD;
      choice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and&#xD;
      an abundance of evidence of harm. In 2017, the Centers for Disease Control and Prevention&#xD;
      (CDC) issued the &quot;CDC Guideline for Prescribing Opioids for Chronic Pain&quot; to encourage safe&#xD;
      and effective alternatives to opioids, discontinuation of opioids when patients do not resume&#xD;
      normal activities and prudent dosing strategies. However, poor guideline adherence is a&#xD;
      general concern and may impede uptake. Our prior studies have used insights from behavioral&#xD;
      economics and social psychology to increase guideline adherence. The objective of the R21&#xD;
      pilot phase of the Application of Economics &amp; Social psychology to improve Opioid Prescribing&#xD;
      Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain&#xD;
      and CDC guidelines for opioid prescribing for persons with noncancer pain. At the time of&#xD;
      opioid prescribing, clinicians will be prompted with an EHR nudge when the prescribing&#xD;
      history for the patient falls into one of the following three mutually exclusive categories:&#xD;
      Opioid naïve, At-risk for long term use, or Long-term opioid recipient. The primary outcome&#xD;
      is average weekly morphine milligram equivalents (MME) prescribed per-clinician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Weekly Milligram Morphine Equivalent (MME)</measure>
    <time_frame>34 weeks</time_frame>
    <description>Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Opioid Use, Unspecified</condition>
  <arm_group>
    <arm_group_label>Clinical Decision Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinical decision support nudges within the electronic health record to discourage unnecessary opioid prescribing through the application of &quot;behavioral insights&quot;-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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Opioid naive</intervention_name>
    <description>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</description>
    <arm_group_label>Clinical Decision Support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>At-risk for long term use</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</description>
    <arm_group_label>Clinical Decision Support</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</description>
    <arm_group_label>Clinical Decision Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NM clinic that sees patients ≥ 18 years old whose leadership agrees to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>February 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <results_first_submitted>July 7, 2021</results_first_submitted>
  <results_first_submitted_qc>July 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 16, 2022</results_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 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>Professor</investigator_title>
  </responsible_party>
  <keyword>Opioids</keyword>
  <keyword>Behavioral Research</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03773484/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>41 primary care clinicians from 3 clinics at Northwestern Medicine in Chicago, Illinois were enrolled.</recruitment_details>
      <pre_assignment_details>Only clinicians listed as a treating member of the clinic receive the intervention.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Clinical Decision Support Nudges</title>
          <description>Opioid naïve: 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&#xD;
At-risk for long term use: 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&#xD;
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</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre-intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Post-intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>5 clinicians were excluded from analysis due to lack of prescribing data</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>41 clinicians from 3 Northwestern Medicine clinics were enrolled</population>
      <group_list>
        <group group_id="B1">
          <title>Clinical Decision Support</title>
          <description>Participating clinicians will receive any of three clinical decision support nudges within the electronic health record when eligibility criteria are met within a patient's chart:&#xD;
Opioid naïve: 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&#xD;
At risk for long term use: 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&#xD;
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</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average weekly milligram morphine equivalent (MME)</title>
          <units>Weekly MME</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Opioid naive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.88" spread="86.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At risk for long term use</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.44" spread="168.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Weekly Milligram Morphine Equivalent (MME)</title>
        <description>Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention</description>
        <time_frame>34 weeks</time_frame>
        <population>Of the 41 clinicians enrolled in the study, 5 were excluded due to lack of prescribing information.</population>
        <group_list>
          <group group_id="O1">
            <title>Clinical Decision Support Nudges</title>
            <description>Opioid naïve&#xD;
At-risk for long term use&#xD;
Long-term opioid recipient&#xD;
Details can be found in the Arms and Interventions section.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Weekly Milligram Morphine Equivalent (MME)</title>
          <description>Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention</description>
          <population>Of the 41 clinicians enrolled in the study, 5 were excluded due to lack of prescribing information.</population>
          <units>Weekly MME per clinician</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Opioid naïve</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.62" spread="97.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At-risk for long term use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.37" spread="102.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Long-term opioid recipient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">MME cannot be calculated because the algorithm for long term opioids was not fully built at the conclusion of the study pilot. It was built and deployed for our full RCT (NCT04477304)</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Pre post comparison for Opioid Naïve patients</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.43</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Slope</param_type>
            <param_value>-0.008</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.011</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Pre-post comparison for at-risk for long term use patients</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.24</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Slope</param_type>
            <param_value>-0.019</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.016</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.051</ci_lower_limit>
            <ci_upper_limit>0.013</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Clinical Decision Support Nudges</title>
          <description>Opioid naïve&#xD;
At-risk for long term use&#xD;
Long-term opioid recipient&#xD;
Details can be found in the Arms and Interventions section.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jason Doctor</name_or_title>
      <organization>University of Southern California</organization>
      <phone>213-821-8142</phone>
      <email>jdoctor@usc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03773484
org study id: HS-CG-17-00019
secondary id: R21AG057395-01
nct id: NCT03773484
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and
      an abundance of evidence of harm. In 2017, the Centers for Disease Control and Prevention
      (CDC) issued the "CDC Guideline for Prescribing Opioids for Chronic Pain" to encourage safe
      and effective alternatives to opioids, discontinuation of opioids when patients do not resume
      normal activities and prudent dosing strategies. However, poor guideline adherence is a
      general concern and may impede uptake. Our prior studies have used insights from behavioral
      economics and social psychology to increase guideline adherence. 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. At the time of
      opioid prescribing, clinicians 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. The primary outcome
      is average weekly morphine milligram equivalents (MME) prescribed per-clinician.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Average Weekly Milligram Morphine Equivalent (MME)
time frame: 34 weeks
description: Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention
arm group label: Clinical Decision Support
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Opioid naive
description: 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
arm group label: Clinical Decision Support
intervention type: Behavioral
intervention name: At-risk for long term use
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
arm group label: Clinical Decision Support
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
arm group label: Clinical Decision Support
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: Professor
mesh term: Analgesics, Opioid
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 