Clinical trial NCT02262351: Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting
Official title: Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Screening
Family Practice
Novel screening technologies
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-10-13
Enrollment: 2174
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Performance of screening tests
timeFrame: Baseline visit
Secondary outcomes:
measure: Cost of each method per case of actionable AF detected
timeFrame: 90 days
measure: Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints
timeFrame: 90 days
measure: 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
timeFrame: 90 days
measure: Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.
timeFrame: 90 days
measure: Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).
timeFrame: 90 days
measure: Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.
timeFrame: 90 days
measure: Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF.
timeFrame: 90 days
measure: Time taken for each screening test
timeFrame: Baseline
measure: Death rate for each case of actionable AFib identified
timeFrame: 90 days
measure: Stroke or transient ischemic attack rate for each case of actionable AFib identified
timeFrame: 90 days
measure: Systemic embolism rate for each case of actionable AFib identified
timeFrame: 90 days
measure: Myocardial infarction rate rate for each case of actionable AFib identified
timeFrame: 90 days
measure: Significant bleeding rate for each case of actionable AFib identified
timeFrame: 90 days
measure: Hospitalization due to heart failure rate for each case of actionable AFib identified
timeFrame: 90 days
Other outcomes:
Locations:
city: Black Diamond
country: Canada
facility: Foothills Family Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Crowfoot Village Family Practice
state: Alberta
city: Camrose
country: Canada
facility: Smith Clinic, Camrose PCN
state: Alberta
city: Edmonton
country: Canada
facility: Abbottsfield Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Alta Clinical Research
state: Alberta
city: Edmonton
country: Canada
facility: Edmonton Oliver PCN
state: Alberta
city: Olds
country: Canada
facility: Peaks to Prairies PCN
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Medical Clinic
state: Ontario
city: Kingston
country: Canada
facility: Queen's Family Health Team
state: Ontario
city: Kirkfield
country: Canada
facility: Kirkfield Medical Centre
state: Ontario
city: Markham
country: Canada
facility: Ken Ng Family Practice / Total Health Management
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc
state: Ontario
city: Owen Sound
country: Canada
facility: Dr. Mark Robertson Family Practice
state: Ontario
city: Thunder Bay
country: Canada
facility: The Port Arthur Clinic Research Program
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Dennis Weston Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Village Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Waterloo
country: Canada
facility: Sameh Fikry Medicine Professional Corporation
state: Ontario
Study officials:
affiliation: University of Calgary
name: F. Russell Quinn, MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.