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

NCT02745236 | Completed DMC

• 1 other identifier: MSmig01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Health Related Quality of Life; Nurse Practitioner; Sustainable Models of Healthcare; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups

  At 6 months

Secondary Outcomes (3)

• Difference in change in EQ-5D scores between groups

  At 6 months

• Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups

  At 6 months

• Satisfaction with NP-led or cardiologist care as measured by the overall mean score of the Consultant Satisfaction Questionnaire (CSG).

  At 6 months

Study Arms (2)

Nurse Practitioner Led-Care

EXPERIMENTAL

Nurse Practitioner (NP) Intervention Initial Visit and Interventions: An experienced nurse practitioner with extra atrial fibrillation (AF) management training will complete the initial assessment to determine a treatment plan based on current AF Guidelines. The NP will provide patient education on AF management. Follow-up: Follow-up will occur at 3 and 6 months from baseline to evaluate the patient's response to treatment and will be modified as required based on AF symptoms, testing results and physical assessment. A physician will be consulted for advanced specialty AF management or if a patient requires admission to hospital.

Other: Nurse Practitioner Led-Care

Cardiologist Led-Care

ACTIVE COMPARATOR

Standard Care Initial Visit and Intervention: A general cardiologist will manage patients as per their usual practice. Follow-up: As per the cardiologist's usual practice. The patient's care will remain with the family physician if no follow-up is required. Follow-up: Follow-up will be determined as per the cardiologist's usual practice. If a follow-up appointment is required it will done in the cardiologist's own independent clinic. The patient's care will be referred back to the family physician if no follow-up is required.

Other: Cardiologist Led-Care

Interventions

Nurse Practitioner Led-Care OTHER

Diagnosis and treatment plan decisions will be determined by Nurse Practitioner Led-Care.

Also known as: Intervention Arm

Nurse Practitioner Led-Care

Cardiologist Led-Care OTHER

Diagnosis and treatment plan decisions will be determined as per usual care by the Cardiologist

Also known as: Control Arm

Cardiologist Led-Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• University Hospital Foundation: collaborator

Study Sites (1)

Mazankowski Alberta Heart Institution

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (20)

• 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. No abstract available.

  PMID: 25547545 BACKGROUND

• 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.

  PMID: 25262857 BACKGROUND

• Faxon DP, Schwamm LH, Pasternak RC, Peterson ED, McNeil BJ, Bufalino V, Yancy CW, Brass LM, Baker DW, Bonow RO, Smaha LA, Jones DW, Smith SC Jr, Ellrodt G, Allen J, Schwartz SJ, Fonarow G, Duncan P, Horton K, Smith R, Stranne S, Shine K; American Heart Association's Expert Panel on Disease Management. Improving quality of care through disease management: principles and recommendations from the American Heart Association's Expert Panel on Disease Management. Circulation. 2004 Jun 1;109(21):2651-4. doi: 10.1161/01.CIR.0000128373.90851.7B. No abstract available.

  PMID: 15173048 BACKGROUND

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  PMID: 23418263 BACKGROUND

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  PMID: 18340388 BACKGROUND

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  PMID: 10764366 BACKGROUND

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  PMID: 16378563 BACKGROUND

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  PMID: 18460162 BACKGROUND

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  PMID: 25172368 BACKGROUND

• 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.

  PMID: 22453654 BACKGROUND

• Johnston BC, Patrick DL, Busse JW, Schunemann HJ, Agarwal A, Guyatt GH. Patient-reported outcomes in meta-analyses--Part 1: assessing risk of bias and combining outcomes. Health Qual Life Outcomes. 2013 Jul 1;11:109. doi: 10.1186/1477-7525-11-109.

  PMID: 23815754 BACKGROUND

• 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.

  PMID: 21160035 BACKGROUND

• 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. doi: 10.1016/s0828-282x(06)70922-9.

  PMID: 16639472 BACKGROUND

• 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.

  PMID: 19808471 BACKGROUND

• Baker R. Development of a questionnaire to assess patients' satisfaction with consultations in general practice. Br J Gen Pract. 1990 Dec;40(341):487-90.

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  PMID: 8745848 BACKGROUND

• 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. doi: 10.1016/s0828-282x(09)70530-6.

  PMID: 19960130 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Smigorowsky MJ, Norris CM, McMurtry MS, Tsuyuki RT. Measuring the effect of nurse practitioner (NP)-led care on health-related quality of life in adult patients with atrial fibrillation: study protocol for a randomized controlled trial. Trials. 2017 Aug 3;18(1):364. doi: 10.1186/s13063-017-2111-4.

  PMID: 28774317 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Patient Satisfaction

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marcie J Smigorowsky, PhD, NP

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Ross T Tsuyuki, PharmD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student Faculty of Medicine and Dentistry

Study Record Dates

• First Submitted: April 16, 2016
• First Posted: April 20, 2016
• Study Start: July 31, 2016
• Primary Completion: September 1, 2020
• Study Completion: November 30, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (1)