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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nurse Practitioner Led-Care
Cardiologist Led-Care
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Health Related Quality of Life, Nurse Practitioner, Sustainable Models of Healthcare, Patient Satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mazankowski Alberta Heart Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nurse Practitioner Led-Care

Cardiologist Led-Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in change in EQ-5D scores between groups
Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups
Satisfaction with NP-led or cardiologist care as measured by the overall mean score of the Consultant Satisfaction Questionnaire (CSG).

Full Information

First Posted
April 16, 2016
Last Updated
April 27, 2021
Sponsor
University of Alberta
Collaborators
University Hospital Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02745236
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2016 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
University Hospital Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Health Related Quality of Life, Nurse Practitioner, Sustainable Models of Healthcare, Patient Satisfaction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse Practitioner Led-Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Cardiologist Led-Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nurse Practitioner Led-Care
Other Intervention Name(s)
Intervention Arm
Intervention Description
Diagnosis and treatment plan decisions will be determined by Nurse Practitioner Led-Care.
Intervention Type
Other
Intervention Name(s)
Cardiologist Led-Care
Other Intervention Name(s)
Control Arm
Intervention Description
Diagnosis and treatment plan decisions will be determined as per usual care by the Cardiologist
Primary Outcome Measure Information:
Title
Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Difference in change in EQ-5D scores between groups
Time Frame
At 6 months
Title
Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups
Time Frame
At 6 months
Title
Satisfaction with NP-led or cardiologist care as measured by the overall mean score of the Consultant Satisfaction Questionnaire (CSG).
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcie J Smigorowsky, PhD, NP
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ross T Tsuyuki, PharmD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mazankowski Alberta Heart Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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The Effect of Nurse Practitioner Led-Care on Quality of Life in Patients With Atrial Fibrillation

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