<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/NCT04476524</url>
  </required_header>
  <id_info>
    <org_study_id>KCHRF-ER2EP-0004</org_study_id>
    <nct_id>NCT04476524</nct_id>
  </id_info>
  <brief_title>Clinical and Economic Impact of an Organized Treatment Pathway on AFib Patient Management From the ER</brief_title>
  <acronym>ER2EP</acronym>
  <official_title>Clinical and Economic Impact of an Organized Treatment Pathway on Atrial Fibrillation Patient Management From the Emergency Room</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas City Heart Rhythm Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kansas City Heart Rhythm Research Foundation</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>
      Investigators developed a multidimensional protocol for the management of AF in the emergency&#xD;
      department. Investigators aimed to assess if this new ER AF management protocol would result&#xD;
      in better outcomes compared to routine care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Management variation such as selecting rate vs rhythm control, timing and need for&#xD;
      thromboembolic treatment, ER vs inpatient treatment and cardiology consultation could lead to&#xD;
      disparate care of patients. Therefore, there is a need for future studies to standardize&#xD;
      practice leading to improved management, decreased rates of hospitalization and overall cost.&#xD;
      Investigators developed a multidimensional protocol for the management of AF in the emergency&#xD;
      department. Investigators aimed to assess if this new ER AF management protocol would result&#xD;
      in better outcomes compared to routine care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative resource utilization in dollars</measure>
    <time_frame>15 months</time_frame>
    <description>Primary Outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to definitive therapy (AAD and or Ablation)</measure>
    <time_frame>15 months</time_frame>
    <description>Primary Outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Hospital/clinic visits</measure>
    <time_frame>15 months</time_frame>
    <description>Primary Outcome</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cardiac Arrhythmia</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Study Arm</arm_group_label>
    <description>Patients who present with AF as the primary diagnosis to the ER will have their chart reviewed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical Cohort</arm_group_label>
    <description>Historical control arm will be selected from chart review of emergency department prior to the commencement of this study after propensity matching with age and sex.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality improvement</intervention_name>
    <description>All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER. Patients will be followed up and outcomes will be compared between two groups at 1, 3, 6 and 12 months.</description>
    <arm_group_label>Historical Cohort</arm_group_label>
    <arm_group_label>Study Arm</arm_group_label>
    <other_name>All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER.</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        i) Study arm: Patients &gt; 18 years of age (both males and females) who present with AF as&#xD;
        the primary diagnosis to the ER will have their chart reviewed.&#xD;
&#xD;
        ii) Historical control arm:Historical control arm will be selected from chart review of&#xD;
        emergency department prior to the commencement of this study after propensity matching with&#xD;
        age and sex. All patients &gt; 18 years of age (both males and females) who presented with AF&#xD;
        as primary diagnosis to the ER of the participating centers within last 2 years will be&#xD;
        selected if they meet the inclusion/exclusion criteria mentioned below&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients &gt; 18 years of age who comes to the ER with AF as the primary&#xD;
             diagnosis and is treated according to study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with established cardiology or electrophysiology care.&#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>Dhanunjaya Lakkireddy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City Heart Rhythm Research Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donita Atkins</last_name>
    <phone>816-651-1969</phone>
    <email>datkins@kchrf.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kansas City Heart Rhythm Institute</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donita Atkins</last_name>
      <phone>816-651-1969</phone>
      <email>datkins@kchrf.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.</citation>
    <PMID>24345399</PMID>
  </reference>
  <reference>
    <citation>Savelieva I, Camm J. Update on atrial fibrillation: part I. Clin Cardiol. 2008 Feb;31(2):55-62. doi: 10.1002/clc.20138.</citation>
    <PMID>18257025</PMID>
  </reference>
  <reference>
    <citation>Dagres N, Chao TF, Fenelon G, Aguinaga L, Benhayon D, Benjamin EJ, Bunch TJ, Chen LY, Chen SA, Darrieux F, de Paola A, Fauchier L, Goette A, Kalman J, Kalra L, Kim YH, Lane DA, Lip GYH, Lubitz SA, Marquez MF, Potpara T, Pozzer DL, Ruskin JN, Savelieva I, Teo WS, Tse HF, Verma A, Zhang S, Chung MK; ESC Scientific Document Group. European Heart Rhythm Association (EHRA)/Heart Rhythm Society (HRS)/Asia Pacific Heart Rhythm Society (APHRS)/Latin American Heart Rhythm Society (LAHRS) expert consensus on arrhythmias and cognitive function: what is the best practice? Europace. 2018 Sep 1;20(9):1399-1421. doi: 10.1093/europace/euy046. No abstract available.</citation>
    <PMID>29562326</PMID>
  </reference>
  <reference>
    <citation>Tse G, Lip GYH, Liu T. The CHADS2 and CHA2DS2-VASc scores for predicting healthcare utilization and outcomes: Observations on the Appropriate Use and Misuse of Risk scores. Int J Cardiol. 2017 Oct 15;245:181-182. doi: 10.1016/j.ijcard.2017.07.109. No abstract available.</citation>
    <PMID>28874290</PMID>
  </reference>
  <reference>
    <citation>Rozen G, Hosseini SM, Kaadan MI, Biton Y, Heist EK, Vangel M, Mansour MC, Ruskin JN. Emergency Department Visits for Atrial Fibrillation in the United States: Trends in Admission Rates and Economic Burden From 2007 to 2014. J Am Heart Assoc. 2018 Jul 20;7(15):e009024. doi: 10.1161/JAHA.118.009024.</citation>
    <PMID>30030215</PMID>
  </reference>
  <reference>
    <citation>Scheuermeyer FX, Innes G, Pourvali R, Dewitt C, Grafstein E, Heslop C, MacPhee J, Ward J, Heilbron B, McGrath L, Christenson J. Missed opportunities for appropriate anticoagulation among emergency department patients with uncomplicated atrial fibrillation or flutter. Ann Emerg Med. 2013 Dec;62(6):557-565.e2. doi: 10.1016/j.annemergmed.2013.04.004. Epub 2013 May 24.</citation>
    <PMID>23711880</PMID>
  </reference>
  <reference>
    <citation>Funk AM, Kocher KE, Rohde JM, West BT, Crawford TC, Froehlich JB, Saberi S. Variation in practice patterns among specialties in the acute management of atrial fibrillation. BMC Cardiovasc Disord. 2015 Mar 12;15:21. doi: 10.1186/s12872-015-0009-1.</citation>
    <PMID>25880061</PMID>
  </reference>
  <reference>
    <citation>Rogenstein C, Kelly AM, Mason S, Schneider S, Lang E, Clement CM, Stiell IG. An international view of how recent-onset atrial fibrillation is treated in the emergency department. Acad Emerg Med. 2012 Nov;19(11):1255-60. doi: 10.1111/acem.12016.</citation>
    <PMID>23167856</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clinical and Economical impact</keyword>
  <keyword>Treatment pathway</keyword>
  <keyword>Emergency Room</keyword>
  <keyword>Atrial Fibrillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</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/NCT04476524
org study id: KCHRF-ER2EP-0004
nct id: NCT04476524
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators developed a multidimensional protocol for the management of AF in the emergency
      department. Investigators aimed to assess if this new ER AF management protocol would result
      in better outcomes compared to routine care.
Management variation such as selecting rate vs rhythm control, timing and need for
      thromboembolic treatment, ER vs inpatient treatment and cardiology consultation could lead to
      disparate care of patients. Therefore, there is a need for future studies to standardize
      practice leading to improved management, decreased rates of hospitalization and overall cost.
      Investigators developed a multidimensional protocol for the management of AF in the emergency
      department. Investigators aimed to assess if this new ER AF management protocol would result
      in better outcomes compared to routine care.
observational model: Cohort
time perspective: Retrospective
measure: Cumulative resource utilization in dollars
time frame: 15 months
description: Primary Outcome
measure: Time to definitive therapy (AAD and or Ablation)
time frame: 15 months
description: Primary Outcome
measure: Number of Hospital/clinic visits
time frame: 15 months
description: Primary Outcome
arm group label: Study Arm
description: Patients who present with AF as the primary diagnosis to the ER will have their chart reviewed
arm group label: Historical Cohort
description: Historical control arm will be selected from chart review of emergency department prior to the commencement of this study after propensity matching with age and sex.
intervention type: Other
intervention name: Quality improvement
description: All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER. Patients will be followed up and outcomes will be compared between two groups at 1, 3, 6 and 12 months.
arm group label: Historical Cohort
arm group label: Study Arm
other name: All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dhanunjaya Lakkireddy
role: Principal Investigator
affiliation: Kansas City Heart Rhythm Research Foundation
last name: Donita Atkins
phone: 816-651-1969
email: datkins@kchrf.com
facility: 
status: Recruiting
contact: 
country: United States
citation: Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
PMID: 24345399
citation: Savelieva I, Camm J. Update on atrial fibrillation: part I. Clin Cardiol. 2008 Feb;31(2):55-62. doi: 10.1002/clc.20138.
PMID: 18257025
citation: Dagres N, Chao TF, Fenelon G, Aguinaga L, Benhayon D, Benjamin EJ, Bunch TJ, Chen LY, Chen SA, Darrieux F, de Paola A, Fauchier L, Goette A, Kalman J, Kalra L, Kim YH, Lane DA, Lip GYH, Lubitz SA, Marquez MF, Potpara T, Pozzer DL, Ruskin JN, Savelieva I, Teo WS, Tse HF, Verma A, Zhang S, Chung MK; ESC Scientific Document Group. European Heart Rhythm Association (EHRA)/Heart Rhythm Society (HRS)/Asia Pacific Heart Rhythm Society (APHRS)/Latin American Heart Rhythm Society (LAHRS) expert consensus on arrhythmias and cognitive function: what is the best practice? Europace. 2018 Sep 1;20(9):1399-1421. doi: 10.1093/europace/euy046. No abstract available.
PMID: 29562326
citation: Tse G, Lip GYH, Liu T. The CHADS2 and CHA2DS2-VASc scores for predicting healthcare utilization and outcomes: Observations on the Appropriate Use and Misuse of Risk scores. Int J Cardiol. 2017 Oct 15;245:181-182. doi: 10.1016/j.ijcard.2017.07.109. No abstract available.
PMID: 28874290
citation: Rozen G, Hosseini SM, Kaadan MI, Biton Y, Heist EK, Vangel M, Mansour MC, Ruskin JN. Emergency Department Visits for Atrial Fibrillation in the United States: Trends in Admission Rates and Economic Burden From 2007 to 2014. J Am Heart Assoc. 2018 Jul 20;7(15):e009024. doi: 10.1161/JAHA.118.009024.
PMID: 30030215
citation: Scheuermeyer FX, Innes G, Pourvali R, Dewitt C, Grafstein E, Heslop C, MacPhee J, Ward J, Heilbron B, McGrath L, Christenson J. Missed opportunities for appropriate anticoagulation among emergency department patients with uncomplicated atrial fibrillation or flutter. Ann Emerg Med. 2013 Dec;62(6):557-565.e2. doi: 10.1016/j.annemergmed.2013.04.004. Epub 2013 May 24.
PMID: 23711880
citation: Funk AM, Kocher KE, Rohde JM, West BT, Crawford TC, Froehlich JB, Saberi S. Variation in practice patterns among specialties in the acute management of atrial fibrillation. BMC Cardiovasc Disord. 2015 Mar 12;15:21. doi: 10.1186/s12872-015-0009-1.
PMID: 25880061
citation: Rogenstein C, Kelly AM, Mason S, Schneider S, Lang E, Clement CM, Stiell IG. An international view of how recent-onset atrial fibrillation is treated in the emergency department. Acad Emerg Med. 2012 Nov;19(11):1255-60. doi: 10.1111/acem.12016.
PMID: 23167856
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Arrhythmias, Cardiac
sharing ipd: No