Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting (PIAAF-FP)

Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment of AF is one of the best way to prevent stroke. The problem is that because AF may cause minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is known that as many as half of all patients with known AF may not be receiving appropriate anticoagulation for their condition. New technologies are making it possible to improve AF detection. Subjects in this study will be screened for AF using three simple methods: a 30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood pressure monitor with built-in AF screening capabilities. If more patients with AF can be detected, more patients will be able to receive guideline-recommended anticoagulant therapy, and more strokes, deaths, disability, and dementia will be prevented.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: 30 Second Pulse Check; Device: Watch BP Home A; Device: HeartCheck Hand-held ECG device

Detailed Description

Participants will be screened for AF using three simple methods (pulse check, single-lead ECG, blood pressure machine with automated AF detection algorithms). Subjects screening positive on any test will attend for a 12-lead ECG within 24 h. For all patients with AF detected, clinical characteristics and medications will be compared at baseline and 90±14 days later.

• Study Type: Interventional
• Enrollment (Actual): 2174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Black Diamond, Alberta, Canada
      • Foothills Family Medical Centre
    • Calgary, Alberta, Canada
      • Crowfoot Village Family Practice
    • Camrose, Alberta, Canada
      • Smith Clinic, Camrose PCN
    • Edmonton, Alberta, Canada
      • Abbottsfield Medical Centre
    • Edmonton, Alberta, Canada
      • Alta Clinical Research
    • Edmonton, Alberta, Canada
      • Edmonton Oliver PCN
    • Olds, Alberta, Canada
      • Peaks to Prairies PCN
  • Ontario
    • Hamilton, Ontario, Canada
      • Hamilton Medical Clinic
    • Kingston, Ontario, Canada
      • Queen's Family Health Team
    • Kirkfield, Ontario, Canada
      • Kirkfield Medical Centre
    • Markham, Ontario, Canada
      • Ken Ng Family Practice / Total Health Management
    • Newmarket, Ontario, Canada
      • SKDS Research Inc
    • Owen Sound, Ontario, Canada
      • Dr. Mark Robertson Family Practice
    • Thunder Bay, Ontario, Canada
      • The Port Arthur Clinic Research Program
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada
      • Women's College Hospital
    • Toronto, Ontario, Canada
      • Mount Dennis Weston Health Centre
    • Toronto, Ontario, Canada
      • Village Health Centre
    • Waterloo, Ontario, Canada
      • Sameh Fikry Medicine Professional Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥65 years.
2. Attending their usual Primary Care Clinic.
3. Provide written informed consent.

Exclusion Criteria:

1. Patients considered by the Investigator to be unsuitable for study follow-up because the patient:

   1. is unreliable concerning the follow-up schedule
   2. cannot be contacted by telephone
   3. has a life expectancy less than the anticipated study duration due to concomitant disease.
2. Presence of an implanted pacemaker or defibrillator.
3. Inability to have a BP cuff applied.
4. Documented significant allergy to ECG electrode adhesive.
5. Previously screened as part of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening; Subjects will undergo three screening methods for atrial fibrillation: 30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device	Other: 30 Second Pulse Check; To detect atrial fibrillation; Device: Watch BP Home A; Blood pressure device that detects atrial fibrillation; Device: HeartCheck Hand-held ECG device; To detect atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of screening tests	The sensitivity and specificity of SL-ECG and BP-AF will be separately compared with that of pulse palpation alone using McNemar's method. This method can be used when only those subjects screening positive attend for confirmatory testing (12-lead ECG ± Holter monitor). A 2-sided alpha of 0.025 will be used to allow for multiple comparisons. A further analysis will be performed using the SL-ECG data as the gold standard. To ensure adequate diagnostic quality, this analysis will only be performed if 5% or less of the overall SL-ECG tracings are deemed "uninterpretable". A bipolar ECG interpreted by a cardiologist has a reported 99% sensitivity and 96% specificity for the diagnosis of AF. If this exploratory analysis is performed it will enable estimation of the sensitivity and specificity of the pulse-check and BP-AF device.	Baseline visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Cost of each method per case of actionable AF detected	90 days
Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints	90 days
Prescription rates at 90±14 days for oral anticoagulant agents (OACs) and drugs for control of heart rate and/or rhythm for patients with actionable AF	90 days
Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.	90 days
Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).	90 days
Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.	90 days
Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF.	90 days
Time taken for each screening test	Baseline
Death rate for each case of actionable AFib identified	90 days
Stroke or transient ischemic attack rate for each case of actionable AFib identified	90 days
Systemic embolism rate for each case of actionable AFib identified	90 days
Myocardial infarction rate rate for each case of actionable AFib identified	90 days
Significant bleeding rate for each case of actionable AFib identified	90 days
Hospitalization due to heart failure rate for each case of actionable AFib identified	90 days

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: F. Russell Quinn, MRCP PhD, University of Calgary

Publications and helpful links

General Publications

• Quinn FR, Gladstone DJ, Ivers NM, Sandhu RK, Dolovich L, Ling A, Nakamya J, Ramasundarahettige C, Frydrych PA, Henein S, Ng K, Congdon V, Birtwhistle RV, Ward R, Healey JS. Diagnostic accuracy and yield of screening tests for atrial fibrillation in the family practice setting: a multicentre cohort study. CMAJ Open. 2018 Aug 2;6(3):E308-E315. doi: 10.9778/cmajo.20180001. Print 2018 Jul-Sep.
• Tarride JE, Quinn FR, Blackhouse G, Sandhu RK, Burke N, Gladstone DJ, Ivers NM, Dolovich L, Thornton A, Nakamya J, Ramasundarahettige C, Frydrych PA, Henein S, Ng K, Congdon V, Birtwhistle RV, Ward R, Healey JS. Is Screening for Atrial Fibrillation in Canadian Family Practices Cost-Effective in Patients 65 Years and Older? Can J Cardiol. 2018 Nov;34(11):1522-1525. doi: 10.1016/j.cjca.2018.05.016. Epub 2018 Jun 21.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): October 15, 2016
• Study Completion (Actual): December 2, 2016

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Screening; Family Practice; Novel screening technologies
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PIAAF-FP