Trial Outcomes & Findings for Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (NCT NCT01927367)
NCT ID: NCT01927367
Last Updated: 2021-03-09
Results Overview
Any unplanned hospitalization (admission with an overnight stay in hospital) due to one of the following causes: acute coronary syndrome, pre-syncope /syncope, transient ischemic attack/ stroke, atrial fibrillation, flutter, pulmonary embolism /deep vein thrombosis /systemic embolism, worsening congestive heart failure including pulmonary edema or dyspnea of cardiac origin. AF-related ED visit was predefined as: any presentation with palpitations, rapid heart rate, presyncope or syncope, shortness of breath, transient chest discomfort, or hemodynamic instability resolving with cardioversion or rate-control, not resulting in hospitalization.
COMPLETED
NA
1145 participants
12 months
2021-03-09
Participant Flow
One participant did not meet inclusion criteria and was excluded from the analysis.
Participant milestones
| Measure |
Clinical Decision Support System for AF
Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).
Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.
|
Usual Care
Usual Care - providers are not eligible to access / use the CDSS.
|
|---|---|---|
|
Overall Study
STARTED
|
597
|
548
|
|
Overall Study
COMPLETED
|
590
|
543
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Clinical Decision Support System for AF
Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).
Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.
|
Usual Care
Usual Care - providers are not eligible to access / use the CDSS.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
|
Overall Study
No baseline data
|
0
|
1
|
Baseline Characteristics
Integrated Management Program Advancing Community Treatment of Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Clinical Decision Support System for AF
n=590 Participants
Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).
Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.
|
Usual Care
n=543 Participants
Usual Care - providers are not eligible to access / use the CDSS.
|
Total
n=1133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
72.1 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
72.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
239 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
351 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
701 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
329 Participants
n=5 Participants
|
308 Participants
n=7 Participants
|
637 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
216 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
416 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
45 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
Canada · Rural Care Nova Scotia
|
315 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
613 Participants
n=5 Participants
|
|
Region of Enrollment
Canada · Urban Care Nova Scotia
|
275 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
520 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAny unplanned hospitalization (admission with an overnight stay in hospital) due to one of the following causes: acute coronary syndrome, pre-syncope /syncope, transient ischemic attack/ stroke, atrial fibrillation, flutter, pulmonary embolism /deep vein thrombosis /systemic embolism, worsening congestive heart failure including pulmonary edema or dyspnea of cardiac origin. AF-related ED visit was predefined as: any presentation with palpitations, rapid heart rate, presyncope or syncope, shortness of breath, transient chest discomfort, or hemodynamic instability resolving with cardioversion or rate-control, not resulting in hospitalization.
Outcome measures
| Measure |
Clinical Decision Support System for AF
n=590 Participants
Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).
Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.
|
Usual Care
n=543 Participants
Usual Care - providers are not eligible to access / use the CDSS.
|
|---|---|---|
|
Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits
|
118 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: 12 months* Individual element of primary outcome. * AF-related emergency department visits.
Outcome measures
| Measure |
Clinical Decision Support System for AF
n=590 Participants
Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).
Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.
|
Usual Care
n=543 Participants
Usual Care - providers are not eligible to access / use the CDSS.
|
|---|---|---|
|
Number of Participants With AF-related Emergency Department Visits
|
78 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data were not available/collected from primary care provider charts that would permit analysis of the time between dates of referral and dates of access for the process of care outcomes.
* Timely access to specialist consultation * Timely access to echocardiograms * Timely access to catheter ablations for AF and atrial flutter
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months\- Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months* The costs associated with the development, implementation, and maintenance of CDSS. * The costs associated with managing and treating patients with AF.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months\- Incremental cost effectiveness ratio between the interventional arm and the control arm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months* Individual element of primary outcome. * AF-related emergency department visits.
Outcome measures
| Measure |
Clinical Decision Support System for AF
n=590 Participants
Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).
Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.
|
Usual Care
n=543 Participants
Usual Care - providers are not eligible to access / use the CDSS.
|
|---|---|---|
|
Number of Participations With CV Hospitalizations
|
40 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsMajor bleeding, as listed above, is to be defined as fatal bleeding and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and /or overt bleeding causing a fall in hemoglobin level of 20 g/L or more, or leading to transfusion of two or more units of whole blood or red cells.
Outcome measures
| Measure |
Clinical Decision Support System for AF
n=590 Participants
Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).
Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.
|
Usual Care
n=543 Participants
Usual Care - providers are not eligible to access / use the CDSS.
|
|---|---|---|
|
Number of Participants With Major Bleeding
|
9 Participants
|
7 Participants
|
Adverse Events
Clinical Decision Support System for AF
Usual Care
Serious adverse events
| Measure |
Clinical Decision Support System for AF
n=590 participants at risk
Providers randomized to access use of the Clinical Decision Support System (CDSS, a web-based tool).
Clinical Decision Support System for AF: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.
|
Usual Care
n=543 participants at risk
Usual Care - providers are not eligible to access / use the CDSS.
|
|---|---|---|
|
Vascular disorders
Major bleeding per ISTH criteria
|
1.5%
9/590 • Number of events 9 • Adverse events were collected over 12 months for each participant's active study phase.
Safety outcomes were monitored and reported at 12 months, including Major bleeding per ISTH criteria as well as All bleeding.
|
1.3%
7/543 • Number of events 7 • Adverse events were collected over 12 months for each participant's active study phase.
Safety outcomes were monitored and reported at 12 months, including Major bleeding per ISTH criteria as well as All bleeding.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jafna L Cox
QEII Health Sciences Centre, Halifax, Nova Scotia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place