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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Nurse Practitioner Led-Care
* Other: Cardiologist Led-Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse Practitioner Led-Care<br>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<br>* Diagnosis and treatment plan decisions will be determined by Nurse Practitioner Led-Care.<br>* Other names: Intervention Arm;|
| Active Comparator: Cardiologist Led-Care<br>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<br>* Diagnosis and treatment plan decisions will be determined as per usual care by the Cardiologist<br>* Other names: Control Arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups |  | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Health Related Quality of Life, Nurse Practitioner, Sustainable Models of Healthcare, Patient Satisfaction