The Effect of Nurse Practitioner Led-Care on Quality of Life in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

The Effect of Nurse Practitioner-Led Care on Health Related Quality Of Life in Adult Patients With Atrial Fibrillation - A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745236
• Other study ID #: MSmig01
• Status: Completed
• Phase: N/A
• Start date: July 31, 2016
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant symptoms as well as increases the person's risk of stroke and heart failure. With an ageing population, increasing rates of AF and limited access to specialists, new methods of care, like nurse practitioners (NP) need to be assessed to meet patient specific needs and provide sustainable care.

The objective of the project is to evaluate the effect of Nurse Practitioner-led care in people with AF on their quality of life.

The Canadian Healthcare system is overwhelmed, with increasing costs and wait times. Contributing to these issues, is AF is the most common arrhythmia accompanied with costly complications including stroke and heart failure. Currently family or emergency room physicians ask general cardiologists or specialized cardiologists, to provide care to patients with AF. Unfortunately, there is limited access to their services. NP's are nurses who have taken extra education at University to treat patients and prescribe medications. This research project involves an NP who has specialized training in AF patient management.

By utilizing an NP to provide care for patients with AF, the investigators hope to improve patient's quality of life and satisfaction with care. This may also reduce complications of AF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Documented non valvular atrial fibrillation

• Able to provide informed consent

• Able and willing to complete the study questionnaires on own or with assistance

Exclusion Criteria:

• Referral is for atrioventricular node ablation or pulmonary vein isolation.

• Patients who have failed antiarrhythmic medications

• Patients with moderate to severe mitral or aortic valvular heart disease

• Clinically unstable atrial fibrillation

• Cannot or unwilling to attend follow-up appointments

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Nurse Practitioner Led-Care
Diagnosis and treatment plan decisions will be determined by Nurse Practitioner Led-Care.
• Cardiologist Led-Care
Diagnosis and treatment plan decisions will be determined as per usual care by the Cardiologist

Locations

Country	Name	City	State
Canada	Mazankowski Alberta Heart Institution	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	University Hospital Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (19)

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Bungard TJ, Smigorowsky MJ, Lalonde LD, Hogan T, Doliszny KM, Gebreyesus G, Garg S, Archer SL. Cardiac EASE (Ensuring Access and Speedy Evaluation) - the impact of a single-point-of-entry multidisciplinary outpatient cardiology consultation program on wait times in Canada. Can J Cardiol. 2009 Dec;25(12):697-702. English, French. — View Citation

Cairns JA, Healey JS, Macle L, Mitchell LB, Verma A; Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee. The new Canadian Cardiovascular Society algorithm for antithrombotic therapy of atrial fibrillation is appropriately based on current epidemiologic data. Can J Cardiol. 2015 Jan;31(1):20-3. doi: 10.1016/j.cjca.2014.11.021. Epub 2014 Nov 26. — View Citation

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Dorian P, Cvitkovic SS, Kerr CR, Crystal E, Gillis AM, Guerra PG, Mitchell LB, Roy D, Skanes AC, Wyse DG. A novel, simple scale for assessing the symptom severity of atrial fibrillation at the bedside: the CCS-SAF scale. Can J Cardiol. 2006 Apr;22(5):383-6. — View Citation

Dorian P, Guerra PG, Kerr CR, O'Donnell SS, Crystal E, Gillis AM, Mitchell LB, Roy D, Skanes AC, Rose MS, Wyse DG. Validation of a new simple scale to measure symptoms in atrial fibrillation: the Canadian Cardiovascular Society Severity in Atrial Fibrillation scale. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):218-24. doi: 10.1161/CIRCEP.108.812347. Epub 2009 Mar 31. — View Citation

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Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, Pison LA, Blaauw Y, Tieleman RG. Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 2012 Nov;33(21):2692-9. doi: 10.1093/eurheartj/ehs071. Epub 2012 Mar 27. Erratum in: Eur Heart J. 2013 Feb;34(6):408. — View Citation

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Kinnersley P, Anderson E, Parry K, Clement J, Archard L, Turton P, Stainthorpe A, Fraser A, Butler CC, Rogers C. Randomised controlled trial of nurse practitioner versus general practitioner care for patients requesting "same day" consultations in primary care. BMJ. 2000 Apr 15;320(7241):1043-8. — View Citation

Oliver GM, Pennington L, Revelle S, Rantz M. Impact of nurse practitioners on health outcomes of Medicare and Medicaid patients. Nurs Outlook. 2014 Nov-Dec;62(6):440-7. doi: 10.1016/j.outlook.2014.07.004. Epub 2014 Aug 1. — View Citation

Poulton BC. Use of the consultation satisfaction questionnaire to examine patients' satisfaction with general practitioners and community nurses: reliability, replicability and discriminant validity. Br J Gen Pract. 1996 Jan;46(402):26-31. — View Citation

Ross H, Higginson LA, Ferguson A, O'Neill BJ, Kells CM, Cox JL, Sholdice MM. Too many patients, too few cardiologists to care? Can J Cardiol. 2006 Sep;22(11):901-2. — View Citation

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Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15. — View Citation

Thrasher C, Purc-Stephenson R. Patient satisfaction with nurse practitioner care in emergency departments in Canada. J Am Acad Nurse Pract. 2008 May;20(5):231-7. doi: 10.1111/j.1745-7599.2008.00312.x. — View Citation

Verma A, Cairns JA, Mitchell LB, Macle L, Stiell IG, Gladstone D, McMurtry MS, Connolly S, Cox JL, Dorian P, Ivers N, Leblanc K, Nattel S, Healey JS; CCS Atrial Fibrillation Guidelines Committee. 2014 focused update of the Canadian Cardiovascular Society Guidelines for the management of atrial fibrillation. Can J Cardiol. 2014 Oct;30(10):1114-30. doi: 10.1016/j.cjca.2014.08.001. Epub 2014 Aug 13. Erratum in: Can J Cardiol. 2014 Dec;30(12):1495. Can J Cardiol. 2015 Oct;31(10):1302. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups		At 6 months
Secondary	Difference in change in EQ-5D scores between groups		At 6 months
Secondary	Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups		At 6 months
Secondary	Satisfaction with NP-led or cardiologist care as measured by the overall mean score of the Consultant Satisfaction Questionnaire (CSG).		At 6 months