<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/NCT03021759</url>
  </required_header>
  <id_info>
    <org_study_id>826125</org_study_id>
    <nct_id>NCT03021759</nct_id>
  </id_info>
  <brief_title>Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence</brief_title>
  <acronym>PRESCRIBE</acronym>
  <official_title>Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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>
      In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled&#xD;
      trial to evaluate an active choice intervention with and without social comparison feedback&#xD;
      to increase physician statin prescribing rates for eligible patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United&#xD;
      States. Strong evidence indicates that statin medications can reduce the risk of CVD and for&#xD;
      those with CVD statins have been shown to reduce mortality. Despite this evidence, statins&#xD;
      are under-prescribed. In this study, the investigators will test the effectiveness of nudges&#xD;
      targeted to physicians using active choice and social comparisons feedback to increasing the&#xD;
      rate at which statin medications are prescribed to patients eligible based on national&#xD;
      practice guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">April 21, 2017</completion_date>
  <primary_completion_date type="Actual">April 21, 2017</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Statin Prescribing Rate</measure>
    <time_frame>Two Months</time_frame>
    <description>Percentage of patients eligible for a statin that have been prescribed a statin</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">4774</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active choice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active choice with social comparison feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active choice</intervention_name>
    <description>Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin</description>
    <arm_group_label>Active choice</arm_group_label>
    <arm_group_label>Active choice with social comparison feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social comparison feedback</intervention_name>
    <description>Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers</description>
    <arm_group_label>Active choice with social comparison feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has a primary care physician at University of Pennsylvania Health System&#xD;
&#xD;
          -  Patient meets 2013 AHA/ACC guidelines for statin therapy but no record of a statin&#xD;
             prescription in the electronic health record&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has an allergy or adverse reaction to statins documented in the electronic&#xD;
             health record&#xD;
&#xD;
          -  Patient has glomerular filtration rate less than 30 mL/min&#xD;
&#xD;
          -  Physicians (and their respective patients) will be excluded if they have less than 10&#xD;
             patients among their entire panel that are eligible for a statin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitesh Patel, MD, MBA, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>October 30, 2018</results_first_submitted>
  <results_first_submitted_qc>March 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 20, 2019</results_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_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>January 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03021759/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>No informed consent was obtained from the participants in this study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>No intervention</description>
        </group>
        <group group_id="P2">
          <title>Active Choice</title>
          <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.&#xD;
Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin</description>
        </group>
        <group group_id="P3">
          <title>Active Choice With Social Comparison Feedback</title>
          <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers&#xD;
Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin.&#xD;
Social comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1566"/>
                <participants group_id="P2" count="1743"/>
                <participants group_id="P3" count="1465"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1566">32 primary care physicians were randomized to this arm and analyzed.</participants>
                <participants group_id="P2" count="1743">32 primary care physicians were randomized to this arm and analyzed.</participants>
                <participants group_id="P3" count="1465">32 primary care physicians were randomized to this arm and analyzed.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>No intervention</description>
        </group>
        <group group_id="B2">
          <title>Active Choice</title>
          <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.&#xD;
Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin</description>
        </group>
        <group group_id="B3">
          <title>Active Choice With Social Comparison Feedback</title>
          <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers&#xD;
Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin&#xD;
Social comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1566"/>
            <count group_id="B2" value="1743"/>
            <count group_id="B3" value="1465"/>
            <count group_id="B4" value="4774"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.1" spread="8.5"/>
                    <measurement group_id="B2" value="62.4" spread="8.2"/>
                    <measurement group_id="B3" value="62.5" spread="8.2"/>
                    <measurement group_id="B4" value="62.4" spread="8.3"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="738"/>
                    <measurement group_id="B2" value="710"/>
                    <measurement group_id="B3" value="701"/>
                    <measurement group_id="B4" value="2149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="828"/>
                    <measurement group_id="B2" value="1033"/>
                    <measurement group_id="B3" value="764"/>
                    <measurement group_id="B4" value="2625"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1004"/>
                    <measurement group_id="B2" value="1110"/>
                    <measurement group_id="B3" value="926"/>
                    <measurement group_id="B4" value="3040"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="420"/>
                    <measurement group_id="B2" value="479"/>
                    <measurement group_id="B3" value="419"/>
                    <measurement group_id="B4" value="1318"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="142"/>
                    <measurement group_id="B2" value="154"/>
                    <measurement group_id="B3" value="120"/>
                    <measurement group_id="B4" value="416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Annual Household Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;50,000 US$</title>
                  <measurement_list>
                    <measurement group_id="B1" value="435"/>
                    <measurement group_id="B2" value="563"/>
                    <measurement group_id="B3" value="406"/>
                    <measurement group_id="B4" value="1404"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50,000 - 100,000 US$</title>
                  <measurement_list>
                    <measurement group_id="B1" value="784"/>
                    <measurement group_id="B2" value="960"/>
                    <measurement group_id="B3" value="733"/>
                    <measurement group_id="B4" value="2477"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;100,000 US$</title>
                  <measurement_list>
                    <measurement group_id="B1" value="341"/>
                    <measurement group_id="B2" value="206"/>
                    <measurement group_id="B3" value="312"/>
                    <measurement group_id="B4" value="859"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Statin Prescribing Rate</title>
        <description>Percentage of patients eligible for a statin that have been prescribed a statin</description>
        <time_frame>Two Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>No intervention</description>
          </group>
          <group group_id="O2">
            <title>Active Choice</title>
            <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.&#xD;
Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin</description>
          </group>
          <group group_id="O3">
            <title>Active Choice With Social Comparison Feedback</title>
            <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers&#xD;
Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin&#xD;
Social comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers</description>
          </group>
        </group_list>
        <measure>
          <title>Statin Prescribing Rate</title>
          <description>Percentage of patients eligible for a statin that have been prescribed a statin</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1566"/>
                <count group_id="O2" value="1743"/>
                <count group_id="O3" value="1465"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="116"/>
                    <measurement group_id="O3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>No intervention</description>
        </group>
        <group group_id="E2">
          <title>Active Choice</title>
          <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.&#xD;
Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin</description>
        </group>
        <group group_id="E3">
          <title>Active Choice With Social Comparison Feedback</title>
          <description>Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers&#xD;
Active choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin&#xD;
Social comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers</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="1566"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1743"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1465"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1566"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1743"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1465"/>
              </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="1566"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1743"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1465"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>Physicians and patients were from a single health care system and we did not have data on prescription fill rates.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Rebecca Pepe</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>215-360-0951</phone>
      <email>peper@pennmedicine.upenn.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/NCT03021759
org study id: 826125
nct id: NCT03021759
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled
      trial to evaluate an active choice intervention with and without social comparison feedback
      to increase physician statin prescribing rates for eligible patients.
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United
      States. Strong evidence indicates that statin medications can reduce the risk of CVD and for
      those with CVD statins have been shown to reduce mortality. Despite this evidence, statins
      are under-prescribed. In this study, the investigators will test the effectiveness of nudges
      targeted to physicians using active choice and social comparisons feedback to increasing the
      rate at which statin medications are prescribed to patients eligible based on national
      practice guidelines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: Statin Prescribing Rate
time frame: Two Months
description: Percentage of patients eligible for a statin that have been prescribed a statin
arm group label: Control
arm group type: No Intervention
description: No intervention
arm group label: Active choice
arm group type: Experimental
description: Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.
arm group label: Active choice with social comparison feedback
arm group type: Experimental
description: Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers
intervention type: Behavioral
intervention name: Active choice
description: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin
arm group label: Active choice
arm group label: Active choice with social comparison feedback
intervention type: Behavioral
intervention name: Social comparison feedback
description: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers
arm group label: Active choice with social comparison feedback
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mitesh Patel, MD, MBA, MS
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Physicians and patients were from a single health care system and we did not have data on prescription fill rates.
point of contact: 