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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03127085
Other study ID # AF ED
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 21, 2017
Est. completion date September 27, 2018

Study information

Verified date February 2019
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This study is a multi-centre, multi-provincial, patient survey using mixed methods. 778 patients will be enrolled from 9 centres in 3 provinces from academic, urban, and rural centres to achieve geographical and health system heterogeneity. The planned duration of the entire study (enrollment through follow-up) is approximately 12 months. Patients presenting to the ED with a primary diagnosis of AF and with a prior diagnosis of established AF will be approached to participate. Each centre will be responsible for obtaining local consent. Data will be stored confidentially and securely at the coordinating centre (Queens University, Kingston, Ontario).

Patients who meet the inclusion criteria will be invited to take part at the time of presentation to the ED or after their ED visit. For all enrolled patients, one follow up telephone call will be made within one to four weeks of the ED visit by a social scientist with specialised training in questionnaires based in Queens University, Kingston, Ontario.


Recruitment information / eligibility

Status Completed
Enrollment 297
Est. completion date September 27, 2018
Est. primary completion date September 27, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Kingston Health Sciences Centre - Kingston General Hospital Site Kingston Ontario

Sponsors (2)

Lead Sponsor Collaborator
Queen's University Cardiac Arrhythmia Network of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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