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

Atrial Fibrillation Clinical Trial

— ER2EP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04476524
• Other study ID #: KCHRF-ER2EP-0004
• Status: Recruiting
• Start date: August 15, 2020
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmia

Intervention

Other:
• Quality improvement
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.

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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, Márquez 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. — View 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. — View 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. — View 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). pii: e009024. doi: 10.1161/JAHA.118.009024. — View Citation

Savelieva I, Camm J. Update on atrial fibrillation: part I. Clin Cardiol. 2008 Feb;31(2):55-62. doi: 10.1002/clc.20138. Review. — View 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. — View Citation

Tse G, Lip GYH, Liu T. The CHADS(2) and CHA(2)DS(2)-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative resource utilization in dollars	Primary Outcome	15 months
Primary	Time to definitive therapy (AAD and or Ablation)	Primary Outcome	15 months
Primary	Number of Hospital/clinic visits	Primary Outcome	15 months