Atrial FibrillationC-CUSP EDNCT02358655
Canadian Community Utilization of Stroke Prevention Study - Emergency Department
A study testing Retrospective review of OAC prescription, Prescription of OAC in ED and Community AF clinic in people with Atrial Fibrillation and Stroke, run by Population Health Research Institute at 5 sites in Canada.
Trial summary
Atrial fibrillation (AF) is a common heart condition, and increases the risk of stroke by six times. There are several medications (blood thinners) that can prevent strokes in AF patients. Many AF patients present to the emergency department, but about half of AF patients leave without prescription of a blood thinner. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Retrospective review of OAC prescription, Prescription of OAC in ED and Community AF clinic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Jun 2015to 8 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who present to the emergency department with electrocardiographically documented atrial fibrillation on a 12 lead ECG
Who cannot join
- Prosthetic or mechanical mitral or aortic valve
- Known rheumatic heart disease
- Unable to provide informed consent
- Will be admitted to hospital
- Life expectancy of < 6 months
- Metastatic malignancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Dartmouth General Hospital
Dartmouth, Nova Scotia
Cobequid Community Health Centre
Halifax, Nova Scotia
Halifax Infirmary
Halifax, Nova Scotia
Dr. Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick
Lions Gate Hospital
North Vancouver, British Columbia
About this study
Atrial fibrillation (AF) is a common heart condition, and increases the risk of stroke by six times. There are several medications (blood thinners) that can prevent strokes in AF patients. Many AF patients present to the emergency department, but about half of AF patients leave without prescription of a blood thinner. The study aims to evaluate if adding options like giving a patient education kit, encouraging emergency room physicians to prescribe a blood thinner and providing a specialized AF clinic to patients will increase the number patients receiving blood thinners to prevent strokes.
Read the detailed description
This is a knowledge translation study will occur in three consecutive phases: Phase 1 is a retrospective chart review of all patients who presented to the emergency department (ED) with ECG documented AF during 1 year prior to study commencement. The main purpose of Phase 1 is to determine if oral anticoagulants (OACs) were prescribed for eligible AF patients at ED discharge. In Phase 2 a low-intensity intervention will be applied in the ED during 6 months, involving physician education, distribution of an AF patient education package, short-term OAC prescription, and a follow-up letter to the patient's family physician. After a one month transition phase, a high intensity intervention will be applied during 6 months in Phase 3. Phase 3 incorporates the Phase 2 intervention, and adds immediate follow-up (within 48-72 hours) in a community AF clinic run by a nurse/pharmacist who is supervised by a specialist in AF.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Retrospective review of OAC prescription, Prescription of OAC in ED, Community AF clinic
- Keywords
- Oral anticoagulant, Knowledge translation, Emergency department
- Medical subject headings
- Atrial Fibrillation, Stroke, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective review of OAC prescriptionOther
Prescription of OAC in EDOther
Community AF clinicOther
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Retrospective Chart Review | Other | Retrospective chart review of all patients who presented to the emergency department (ED) with ECG-documented AF during 1 year prior to study commencement. The main purpose of Phase 1 is to determine if oral anticoagulants were prescribed for eligible AF patients at ED discharge. Receives: Other: Retrospective review of OAC prescription |
| Phase 2: Low-Intensity Intervention | Other | Low-intensity intervention will be applied in the ED during 6 months, involving physician education, distribution of an AF patient education package, short-term oral anticoagulant prescription, and a follow-up letter to the patient's family physician. Receives: Other: Prescription of OAC in ED |
| Phase 3: High-Intensity Intervention | Other | Phase 3 incorporates the Phase 2 intervention, and adds immediate follow-up (within 48-72 hours) in a community AF clinic run by a nurse/pharmacist who is supervised by a specialist in AF. Receives: Other: Prescription of OAC in ED; Other: Community AF clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
New OAC Prescription (Phase 1 and 3 comparison)
Measured: Up to 72 hrs
Secondary outcomes (5)
New OAC Prescription (Phase 1 and 2 comparison)
Measured: Up to 72 hrs
New OAC Prescription (Phase 2 and 3 comparison)
Measured: Up to 72 hrs
OAC use in eligible patients at 30 days (Phase 2 and 3 comparison)
Measured: 30 days
OAC use in eligible patients at 6 months (Phase 2 and 3 comparison)
Measured: 6 months
Uptake of study interventions
This outcome measure is meant to determine feasibility for a larger community cluster RCT. This will be measured by the uptake of the interventions described in this study, including: patient use of the AF educational kit, patient use of AF clinic, attendance at educational presentations for patients, family doctors and emergency physicians, patient use of automated text or email reminders for OACs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study start1 Jun 2015
- Primary completion31 Oct 2016
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ratika Parkash, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358655
- Sponsor's protocol ID
- C-CUSP ED
- Acronym
- C-CUSP ED
- Status last verified
- Oct 2018
- First submitted
- 6 Jan 2015
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Parkash R, Magee K, McMullen M, Clory M, D'Astous M, Robichaud M, Andolfatto G, Read B, Wang J, Thabane L, Atzema C, Dorian P, Kaczorowski J, Banner D, Nieuwlaat R, Ivers N, Huynh T, Curran J, Graham I, Connolly S, Healey J. The Canadian Community Utilization of Stroke Prevention Study in Atrial Fibrillation in the Emergency Department (C-CUSP ED). Ann Emerg Med. 2019 Apr;73(4):382-392. doi: 10.1016/j.annemergmed.2018.09.001. Epub 2018 Oct 26.
PubMed 30502307
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Community Utilization of Stroke Prevention Study - Emergency Department
- ClinicalTrials.gov ID
- NCT02358655
- Acronym / sponsor ID
- C-CUSP ED / C-CUSP ED
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Oral anticoagulant, Knowledge translation, Emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is a common heart condition, and increases the risk of stroke by six times. There are several medications (blood thinners) that can prevent strokes in AF patients. Many AF patients present to the emergency department, but about half of AF patients leave without prescription of a blood thinner. The study aims to evaluate if adding options like giving a patient education kit, encouraging emergency room physicians to prescribe a blood thinner and providing a specialized AF clinic to patients will increase the number patients receiving blood thinners to prevent strokes.
Detailed description
This is a knowledge translation study will occur in three consecutive phases: Phase 1 is a retrospective chart review of all patients who presented to the emergency department (ED) with ECG documented AF during 1 year prior to study commencement. The main purpose of Phase 1 is to determine if oral anticoagulants (OACs) were prescribed for eligible AF patients at ED discharge. In Phase 2 a low-intensity intervention will be applied in the ED during 6 months, involving physician education, distribution of an AF patient education package, short-term OAC prescription, and a follow-up letter to the patient's family physician. After a one month transition phase, a high intensity intervention will be applied during 6 months in Phase 3. Phase 3 incorporates the Phase 2 intervention, and adds immediate follow-up (within 48-72 hours) in a community AF clinic run by a nurse/pharmacist who is supervised by a specialist in AF.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Retrospective Chart Review | Other | Other: Retrospective review of OAC prescriptionRetrospective chart review of all patients who presented to the emergency department (ED) with ECG-documented AF during 1 year prior to study commencement. The main purpose of Phase 1 is to determine if oral anticoagulants were prescribed for eligible AF patients at ED discharge. |
| Phase 2: Low-Intensity Intervention | Other | Other: Prescription of OAC in EDLow-intensity intervention will be applied in the ED during 6 months, involving physician education, distribution of an AF patient education package, short-term oral anticoagulant prescription, and a follow-up letter to the patient's family physician. |
| Phase 3: High-Intensity Intervention | Other | Other: Prescription of OAC in ED, Other: Community AF clinicPhase 3 incorporates the Phase 2 intervention, and adds immediate follow-up (within 48-72 hours) in a community AF clinic run by a nurse/pharmacist who is supervised by a specialist in AF. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who present to the emergency department with electrocardiographically documented atrial fibrillation on a 12 lead ECG
Key exclusion criteria (6 listed)
- Prosthetic or mechanical mitral or aortic valve
- Known rheumatic heart disease
- Unable to provide informed consent
- Will be admitted to hospital
- Life expectancy of < 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective review of OAC prescription | Other | Phase 1: Retrospective Chart Review |
| Prescription of OAC in ED | Other | Phase 2: Low-Intensity Intervention, Phase 3: High-Intensity Intervention |
| Community AF clinic | Other | Phase 3: High-Intensity Intervention |
Primary outcome
New OAC Prescription (Phase 1 and 3 comparison)
Time frame: Up to 72 hrs
5 secondary outcomes
New OAC Prescription (Phase 1 and 2 comparison)
Time frame: Up to 72 hrs
New OAC Prescription (Phase 2 and 3 comparison)
Time frame: Up to 72 hrs
OAC use in eligible patients at 30 days (Phase 2 and 3 comparison)
Time frame: 30 days
OAC use in eligible patients at 6 months (Phase 2 and 3 comparison)
Time frame: 6 months
Uptake of study interventions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 30502307Parkash R, Magee K, McMullen M, Clory M, D'Astous M, Robichaud M, Andolfatto G, Read B, Wang J, Thabane L, Atzema C, Dorian P, Kaczorowski J, Banner D, Nieuwlaat R, Ivers N, Huynh T, Curran J, Graham I, Connolly S, Healey J. The Canadian Community Utilization of Stroke Prevention Study in Atrial Fibrillation in the Emergency Department (C-CUSP ED). Ann Emerg Med. 2019 Apr;73(4):382-392. doi: 10.1016/j.annemergmed.2018.09.001. Epub 2018 Oct 26.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratika Parkash, MD principal investigator
Dalhousie University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrospective review of OAC prescription, Prescription of OAC in ED and Community AF clinic in people with Atrial Fibrillation and Stroke, run by Population Health Research Institute at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New OAC Prescription (Phase 1 and 3 comparison) (time frame: Up to 72 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.