Clinical trial NCT02745236: The Effect of Nurse Practitioner Led-Care on Quality of Life in Patients With Atrial Fibrillation
Official title: The Effect of Nurse Practitioner-Led Care on Health Related Quality Of Life in Adult Patients With Atrial Fibrillation - A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Health Related Quality of Life
Nurse Practitioner
Sustainable Models of Healthcare
Patient Satisfaction
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University Hospital Foundation
First posted: 2016-04-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups
timeFrame: At 6 months
Secondary outcomes:
measure: Difference in change in EQ-5D scores between groups
timeFrame: At 6 months
measure: Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups
timeFrame: At 6 months
measure: Satisfaction with NP-led or cardiologist care as measured by the overall mean score of the Consultant Satisfaction Questionnaire (CSG).
timeFrame: At 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institution
state: Alberta
Study officials:
affiliation: University of Alberta
name: Marcie J Smigorowsky, PhD, NP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Ross T Tsuyuki, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
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