NCT03127085

Brief Summary

Patients with a history of atrial fibrillation (AF) who frequently attend the emergency department (ED) with symptoms may not require emergency treatment, and may be more appropriately managed in an alternative outpatient setting. This may be the result of inappropriate or inadequate advice or a lack of patient understanding. The main research objective pertains to the reason for seeking medical attention for AF in the ED, ED management of the patient, outcomes of ED care and alternative strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

April 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

April 17, 2017

Last Update Submit

February 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient decisions and perceptions before an after attending the emergency department with symptoms which may be related to atrial fibrillation

    A detailed telephone survey will be performed in which patients with a known history of atrial fibrillation and symptoms which they feel are related to their diagnosis and who are agreeable to take part in the study will be called by a social scientist. They will be asked a series of questions and their responses will be recorded either on a Likert scale (symptom severity, satisfaction with treatment, quality of life) or as qualitative data (exact symptoms, fears and concerns relating to their underlying diagnosis)

    All surveys will occur within a time period of less than or equal to four weeks post emergency department visit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a known history of atrial fibrillation that seek emergent medical attention for symptoms of atrial fibrillation.

You may qualify if:

  • Male or female ≥ 18 years of age
  • Atrial fibrillation is the primary reason for ED visit (documented by 12-lead ECG or Holter rhythm strip by a member of the healthcare team providing care to the patient).
  • Patients with an established history of AF (prior diagnosis with ECG / rhythm strip evidence of AF)
  • Patient must be literate in English
  • Patient must provide informed consent

You may not qualify if:

  • Male or female \< 18 years of age
  • Non-English speaking
  • unable and/or unwilling to consent
  • Acute coronary syndrome (ischemic chest pain, ST changes, + troponin \[mild troponin elevation alone does not exclude the patient\])
  • Cardiogenic shock or class IV congestive heart failure at the time of visit
  • Enrolled in a cardiovascular drug or device research study
  • New onset atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston Health Sciences Centre - Kingston General Hospital Site

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

  • Hong KL, Babiolakis C, Zile B, Bullen M, Haseeb S, Halperin F, Hohl CM, Magee K, Sandhu RK, Tian SY, Kennedy A, Lobban T, Mariano Z, Dorian P, Angaran P, Evans M, Leong-Sit P, Glover BM. Canada-wide mixed methods analysis evaluating the reasons for inappropriate emergency department presentation in patients with a history of atrial fibrillation: the multicentre AF-ED trial. BMJ Open. 2020 Apr 16;10(4):e033482. doi: 10.1136/bmjopen-2019-033482.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Benedict Glover, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiac Arrhythmia Service, Queen's University, Kingston, Ontario

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 25, 2017

Study Start

April 21, 2017

Primary Completion

September 27, 2018

Study Completion

September 27, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations