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

April 27, 2021 updated by: Marcie Smigorowsky, University of Alberta

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Mazankowski Alberta Heart Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nurse Practitioner Led-Care

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
Diagnosis and treatment plan decisions will be determined by Nurse Practitioner Led-Care.
Other Names:
  • Intervention Arm
ACTIVE_COMPARATOR: Cardiologist Led-Care

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
Diagnosis and treatment plan decisions will be determined as per usual care by the Cardiologist
Other Names:
  • Control Arm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in change in EQ-5D scores between groups
Time Frame: At 6 months
At 6 months
Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups
Time Frame: At 6 months
At 6 months
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
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

University Hospital Foundation

Investigators

  • Principal Investigator: Marcie J Smigorowsky, PhD, NP, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 31, 2016

Primary Completion (ACTUAL)

September 1, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

April 16, 2016

First Submitted That Met QC Criteria

April 16, 2016

First Posted (ESTIMATE)

April 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSmig01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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