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Clinical and Economic Impact of an Organized Treatment Pathway on AFib Patient Management From the ER

NCT04476524 — Unknown, 200 participants, Kansas City Heart Rhythm Research Foundation

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Clinical and Economic Impact of an Organized Treatment Pathway on Atrial Fibrillation Patient Management From the Emergency Room

RegistryNCT04476524, acronym ER2EP
StatusUnknown
Study typeObservational
Enrollment200 (Estimated)
SponsorKansas City Heart Rhythm Research Foundation (Other)
ConditionsCardiac Arrhythmia, Atrial Fibrillation
InterventionsQuality improvement (Other)
Datesstart 2020-08-15, primary completion 2021-11-01 (estimated), completion 2021-12-01 (estimated), first posted 2020-07-20, last updated 2021-02-04
Locations1 site in United States

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-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Study ArmOther: Quality improvementPatients who present with AF as the primary diagnosis to the ER will have their chart reviewed
Historical CohortOther: Quality improvementHistorical 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.
  • Quality improvement (Other), also known as 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.: 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.

+Outcome measures

Primary outcomes

  • Cumulative resource utilization in dollars [15 months]: Primary Outcome
  • Time to definitive therapy (AAD and or Ablation) [15 months]: Primary Outcome
  • Number of Hospital/clinic visits [15 months]: Primary Outcome

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Consecutive patients > 18 years of age who comes to the ER with AF as the primary diagnosis and is treated according to study protocol.

Exclusion Criteria:

* Patients with established cardiology or electrophysiology care.

+Locations (1)

FacilityCityCountryStatus
Kansas City Heart Rhythm InstituteOverland Park, KansasUnited StatesRecruiting

+Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

+Investigators

My Notes