<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/NCT03271931</url>
  </required_header>
  <id_info>
    <org_study_id>827983</org_study_id>
    <nct_id>NCT03271931</nct_id>
  </id_info>
  <brief_title>Active Choice in the EHR to Promote Statin Therapy</brief_title>
  <official_title>Using Active Choice in the EHR to Promote Cardiologists to Prescribe Evidence-Based Statin Therapy</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>
      Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins&#xD;
      have been demonstrated to be an effective tool for reducing CV events and mortality, but&#xD;
      statins are often either not prescribed or under-prescribed for patients that meet&#xD;
      evidence-based guidelines. In this study, we will evaluate a health system initiative using&#xD;
      active and passive choice prompts in the electronic health record to prompt cardiologists to&#xD;
      prescribe evidence-based statin therapy. In partnership with the health system, this will be&#xD;
      conducted as a randomized, controlled trial to evaluate its effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will use a randomized, controlled trial to evaluate a health system initiative.&#xD;
      Cardiologists randomly assigned to the control arm will receive no interventions. For&#xD;
      cardiologists randomly assigned to the active choice intervention, the electronic health&#xD;
      record will be used to prompt cardiologists to initiate or change statin therapy for patients&#xD;
      not on evidenced-based guidelines based on the 2013 American College of Cardiology / American&#xD;
      Heart Association (ACC/AHA) and the National Lipid Association (NLA) through a &quot;best practice&#xD;
      alert&quot; in Epic which appears on the screen and forces a decision before the clinician can&#xD;
      move on. For cardiologists randomly assigned to the passive choice intervention, the&#xD;
      electronic health record will be used to create a passive alert using the same evidence-based&#xD;
      guidelines. The passive alert will not block clinician workflow and instead will be available&#xD;
      in the background for the cardiologist to open and then use to make a prescribing decision.&#xD;
      The intervention period will be 6 months in duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2018</start_date>
  <completion_date type="Actual">June 5, 2019</completion_date>
  <primary_completion_date type="Actual">June 5, 2019</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines</measure>
    <time_frame>6 Months</time_frame>
    <description>Among patients not on guideline-based statin dosages, the percent that are prescribed guideline-based therapy at appropriate dose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in percentage of eligible patients prescribed a statin, at any dose.</measure>
    <time_frame>6 Months</time_frame>
    <description>Among patients not on a statin, the percent that are prescribed guideline-based therapy, at any dose.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">23066</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Cardiologists in this arm will receive no interventions and will act as usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active choice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cardiologists in this arm will be exposed to an active choice intervention through the electronic health record (EHR) using an alert to prompt recommendations for statin therapy for patients not on guideline-based therapy. Cardiologists will be have to make an active choice to prescribe a statin at the recommended dose or not.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Passive choice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cardiologists in this arm will be exposed to a passive choice alert within the EHR, using the same evidence-based guidelines as in the active choice arm. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active choice</intervention_name>
    <description>EHR alert prompting cardiologists to make an active choice to prescribe a statin or not.</description>
    <arm_group_label>Active choice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Passive choice</intervention_name>
    <description>EHR passive alert to cardiologists about prescribing a statin</description>
    <arm_group_label>Passive choice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a cardiologist at the University of Pennsylvania Health System&#xD;
&#xD;
          -  Meets 2013 ACC/AHA or NLA guidelines for statin prescription&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to statins&#xD;
&#xD;
          -  Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30&#xD;
             mL/min or on dialysis&#xD;
&#xD;
          -  Adverse reaction to statins including a) myopathy, b)rhabdomyolysis, c)hepatitis&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  On a PCSK9 Inhibitor medication&#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>Mitesh Patel, MD, MBA, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</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>July 2019</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03271931
org study id: 827983
nct id: NCT03271931
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins
      have been demonstrated to be an effective tool for reducing CV events and mortality, but
      statins are often either not prescribed or under-prescribed for patients that meet
      evidence-based guidelines. In this study, we will evaluate a health system initiative using
      active and passive choice prompts in the electronic health record to prompt cardiologists to
      prescribe evidence-based statin therapy. In partnership with the health system, this will be
      conducted as a randomized, controlled trial to evaluate its effect.
This study will use a randomized, controlled trial to evaluate a health system initiative.
      Cardiologists randomly assigned to the control arm will receive no interventions. For
      cardiologists randomly assigned to the active choice intervention, the electronic health
      record will be used to prompt cardiologists to initiate or change statin therapy for patients
      not on evidenced-based guidelines based on the 2013 American College of Cardiology / American
      Heart Association (ACC/AHA) and the National Lipid Association (NLA) through a "best practice
      alert" in Epic which appears on the screen and forces a decision before the clinician can
      move on. For cardiologists randomly assigned to the passive choice intervention, the
      electronic health record will be used to create a passive alert using the same evidence-based
      guidelines. The passive alert will not block clinician workflow and instead will be available
      in the background for the cardiologist to open and then use to make a prescribing decision.
      The intervention period will be 6 months in duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines
time frame: 6 Months
description: Among patients not on guideline-based statin dosages, the percent that are prescribed guideline-based therapy at appropriate dose.
measure: Change in percentage of eligible patients prescribed a statin, at any dose.
time frame: 6 Months
description: Among patients not on a statin, the percent that are prescribed guideline-based therapy, at any dose.
arm group label: Usual care
arm group type: No Intervention
description: Cardiologists in this arm will receive no interventions and will act as usual care
arm group label: Active choice
arm group type: Experimental
description: Cardiologists in this arm will be exposed to an active choice intervention through the electronic health record (EHR) using an alert to prompt recommendations for statin therapy for patients not on guideline-based therapy. Cardiologists will be have to make an active choice to prescribe a statin at the recommended dose or not.
arm group label: Passive choice
arm group type: Experimental
description: Cardiologists in this arm will be exposed to a passive choice alert within the EHR, using the same evidence-based guidelines as in the active choice arm. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision.
intervention type: Behavioral
intervention name: Active choice
description: EHR alert prompting cardiologists to make an active choice to prescribe a statin or not.
arm group label: Active choice
intervention type: Behavioral
intervention name: Passive choice
description: EHR passive alert to cardiologists about prescribing a statin
arm group label: Passive choice
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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
sharing ipd: No