Clinical trial NCT04476524: Clinical and Economic Impact of an Organized Treatment Pathway on AFib Patient Management From the ER
Official title: Clinical and Economic Impact of an Organized Treatment Pathway on Atrial Fibrillation Patient Management From the Emergency Room
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmia
Atrial Fibrillation
Keywords: Clinical and Economical impact
Treatment pathway
Emergency Room
Atrial Fibrillation
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: i) Study arm: Patients \> 18 years of age (both males and females) who present with AF as the primary diagnosis to the ER will have their chart reviewed.

ii) Historical control arm: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. All patients \> 18 years of age (both males and females) who presented with AF as primary diagnosis to the ER of the participating centers within last 2 years will be selected if they meet the inclusion/exclusion criteria mentioned below

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative resource utilization in dollars
timeFrame: 15 months
measure: Time to definitive therapy (AAD and or Ablation)
timeFrame: 15 months
measure: Number of Hospital/clinic visits
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Research Foundation
name: Dhanunjaya Lakkireddy
role: PRINCIPAL_INVESTIGATOR
References:
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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: 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: 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: 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: 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: 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.