<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/NCT01734135</url>
  </required_header>
  <id_info>
    <org_study_id>CHFQUERI-1101</org_study_id>
    <nct_id>NCT01734135</nct_id>
  </id_info>
  <brief_title>Provider Notification for High B-type Natriuretic Peptide Values</brief_title>
  <official_title>Trial of Provider Notification for Patients With High B-type Natriuretic Peptide and no Imaging to Identify Unsuspected Heart Failure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Palo Alto Health Care System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposal examines use of a clinical reminder to the primary provider of patient with a&#xD;
      high B type natriuretic peptide but no prior imaging.&#xD;
&#xD;
      Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve&#xD;
      Heart Failure Management in Patients with High BNP Values and Unknown LVEF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: B type natriuretic peptide is known to be elevated (&gt; 100 pg/ml) in patients with&#xD;
      heart failure. Furthermore, treatments are available to improve survival and reduce&#xD;
      hospitalization if the left ventricular ejection fraction (LVEF) is &lt; 40%. Accordingly,&#xD;
      guidelines recommend an LVEF measure for patients with suspected heart failure. Prior work&#xD;
      has demonstrated that patients with high BNP values do not always have a measure of left&#xD;
      ventricular ejection.&#xD;
&#xD;
      Hypothesis: A reminder to patients with BNP and no imaging may prompt providers to order&#xD;
      appropriate imaging potentially leading to 1) identification of unsuspected depressed&#xD;
      ejection fraction and 2) more appropriate treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of left ventricular ejection fraction</measure>
    <time_frame>6 months after randomization</time_frame>
    <description>numerator: Measurement of left ventricular ejection fraction within 6 months of randomization.&#xD;
denominator: All randomized patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of LVEF &lt; 40%</measure>
    <time_frame>6 months following randomizaiton</time_frame>
    <description>Numerator: number of patients identified with an LVEF&lt; 40% Denominator: all randomized patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment of Low LVEF</measure>
    <time_frame>6 months following randomization</time_frame>
    <description>Numerator: number of patients with an LVEF &lt; 40% and treatment with either an angiotensin converting enzyme inhibitor, angiotensin receptor blocker or evidence based beta-blocker (carvedilol, metoprolol succinate, bisoprolol).&#xD;
Denominator: all randomized patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical Reminder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Reminder</intervention_name>
    <description>A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.</description>
    <arm_group_label>Clinical Reminder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BNP &gt;= 200 pg/ml in last 2 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Measure of LVEF in the last 12 months&#xD;
&#xD;
          -  Last measure of LVEF &lt; 40%&#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>Paul A Heidenreich, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Palo Alto HCS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>April 26, 2016</last_update_submitted>
  <last_update_submitted_qc>April 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Palo Alto Health Care System</investigator_affiliation>
    <investigator_full_name>Paul Heidenreich</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>B type natriuretic peptide</keyword>
  <keyword>heart failure</keyword>
  <keyword>cardiac imaging</keyword>
  <keyword>quality of care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_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/NCT01734135
org study id: CHFQUERI-1101
nct id: NCT01734135
lead sponsor: 
has dmc: No
This proposal examines use of a clinical reminder to the primary provider of patient with a
      high B type natriuretic peptide but no prior imaging.

      Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve
      Heart Failure Management in Patients with High BNP Values and Unknown LVEF.
Rationale: B type natriuretic peptide is known to be elevated (> 100 pg/ml) in patients with
      heart failure. Furthermore, treatments are available to improve survival and reduce
      hospitalization if the left ventricular ejection fraction (LVEF) is < 40%. Accordingly,
      guidelines recommend an LVEF measure for patients with suspected heart failure. Prior work
      has demonstrated that patients with high BNP values do not always have a measure of left
      ventricular ejection.

      Hypothesis: A reminder to patients with BNP and no imaging may prompt providers to order
      appropriate imaging potentially leading to 1) identification of unsuspected depressed
      ejection fraction and 2) more appropriate treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Measurement of left ventricular ejection fraction
time frame: 6 months after randomization
description: numerator: Measurement of left ventricular ejection fraction within 6 months of randomization.
denominator: All randomized patients
measure: Identification of LVEF < 40%
time frame: 6 months following randomizaiton
description: Numerator: number of patients identified with an LVEF< 40% Denominator: all randomized patients
measure: Treatment of Low LVEF
time frame: 6 months following randomization
description: Numerator: number of patients with an LVEF < 40% and treatment with either an angiotensin converting enzyme inhibitor, angiotensin receptor blocker or evidence based beta-blocker (carvedilol, metoprolol succinate, bisoprolol).
Denominator: all randomized patients.
arm group label: Usual Care
arm group type: No Intervention
description: Usual care
arm group label: Clinical Reminder
arm group type: Experimental
description: A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.
intervention type: Other
intervention name: Clinical Reminder
description: A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.
arm group label: Clinical Reminder
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul A Heidenreich, MD, MS
role: Principal Investigator
affiliation: VA Palo Alto HCS
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA Palo Alto Health Care System
investigator full name: Paul Heidenreich
investigator title: Investigator
mesh term: Heart Failure