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Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01927367
Recruitment Status : Completed
First Posted : August 22, 2013
Results First Posted : September 16, 2020
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
McMaster University
Population Health Research Institute
St. Joseph's Healthcare Hamilton
Bayer
Information provided by (Responsible Party):
Jafna L Cox, Nova Scotia Health Authority

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Atrial Fibrillation
Intervention Other: Clinical Decision Support System for AF
Enrollment 1145
Recruitment Details  
Pre-assignment Details One participant did not meet inclusion criteria and was excluded from the analysis.
Arm/Group Title Clinical Decision Support System for AF Usual Care
Hide Arm/Group Description

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 - providers are not eligible to access / use the CDSS.
Period Title: Overall Study
Started 597 548
Completed 590 543
Not Completed 7 5
Reason Not Completed
Withdrawal by Subject             7             4
No baseline data             0             1
Arm/Group Title Clinical Decision Support System for AF Usual Care Total
Hide Arm/Group Description

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 - providers are not eligible to access / use the CDSS. Total of all reporting groups
Overall Number of Baseline Participants 590 543 1133
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 590 participants 543 participants 1133 participants
72.5  (10.1) 72.1  (9.9) 72.3  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 590 participants 543 participants 1133 participants
Female
239
  40.5%
193
  35.5%
432
  38.1%
Male
351
  59.5%
350
  64.5%
701
  61.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 590 participants 543 participants 1133 participants
Caucasian
329
  55.8%
308
  56.7%
637
  56.2%
Unknown
216
  36.6%
200
  36.8%
416
  36.7%
Other
45
   7.6%
35
   6.4%
80
   7.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 590 participants 543 participants 1133 participants
Rural Care Nova Scotia
315
  53.4%
298
  54.9%
613
  54.1%
Urban Care Nova Scotia
275
  46.6%
245
  45.1%
520
  45.9%
1.Primary Outcome
Title Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Decision Support System for AF Usual Care
Hide Arm/Group Description:

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 - providers are not eligible to access / use the CDSS.
Overall Number of Participants Analyzed 590 543
Measure Type: Count of Participants
Unit of Measure: Participants
118
  20.0%
130
  23.9%
2.Secondary Outcome
Title Number of Participants With AF-related Emergency Department Visits
Hide Description
  • Individual element of primary outcome.
  • AF-related emergency department visits.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Decision Support System for AF Usual Care
Hide Arm/Group Description:

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 - providers are not eligible to access / use the CDSS.
Overall Number of Participants Analyzed 590 543
Measure Type: Count of Participants
Unit of Measure: Participants
78
  13.2%
96
  17.7%
3.Secondary Outcome
Title Process of Care
Hide Description
  • Timely access to specialist consultation
  • Timely access to echocardiograms
  • Timely access to catheter ablations for AF and atrial flutter
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clinical Decision Support System for AF Usual Care
Hide Arm/Group Description:

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 - providers are not eligible to access / use the CDSS.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Health Related Quality of Life
Hide Description - Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L).
Time Frame 12 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Costs
Hide Description
  • The costs associated with the development, implementation, and maintenance of CDSS.
  • The costs associated with managing and treating patients with AF.
Time Frame 12 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Cost Effectiveness
Hide Description - Incremental cost effectiveness ratio between the interventional arm and the control arm
Time Frame 12 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Number of Participations With CV Hospitalizations
Hide Description
  • Individual element of primary outcome.
  • AF-related emergency department visits.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Decision Support System for AF Usual Care
Hide Arm/Group Description:

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 - providers are not eligible to access / use the CDSS.
Overall Number of Participants Analyzed 590 543
Measure Type: Count of Participants
Unit of Measure: Participants
40
   6.8%
26
   4.8%
8.Other Pre-specified Outcome
Title Number of Participants With Major Bleeding
Hide Description Major 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Decision Support System for AF Usual Care
Hide Arm/Group Description:

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 - providers are not eligible to access / use the CDSS.
Overall Number of Participants Analyzed 590 543
Measure Type: Count of Participants
Unit of Measure: Participants
9
   1.5%
7
   1.3%
Time Frame Adverse events were collected over 12 months for each participant's active study phase.
Adverse Event Reporting Description Safety outcomes were monitored and reported at 12 months, including Major bleeding per ISTH criteria as well as All bleeding.
 
Arm/Group Title Clinical Decision Support System for AF Usual Care
Hide Arm/Group Description

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 - providers are not eligible to access / use the CDSS.
All-Cause Mortality
Clinical Decision Support System for AF Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   28/590 (4.75%)      21/543 (3.87%)    
Hide Serious Adverse Events
Clinical Decision Support System for AF Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/590 (1.53%)      7/543 (1.29%)    
Vascular disorders     
Major bleeding per ISTH criteria   9/590 (1.53%)  9 7/543 (1.29%)  7
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clinical Decision Support System for AF Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/590 (0.00%)      0/543 (0.00%)    
Limitations can be found in the main outcomes paper, which is open access: https://www.sciencedirect.com/science/article/pii/S0002870320300855 The methods paper is also open access: https://www.sciencedirect.com/science/article/pii/S0002870318301170
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jafna L Cox
Organization: QEII Health Sciences Centre, Halifax, Nova Scotia
Phone: (902) 473-7811
EMail: jafna.cox@dal.ca
Layout table for additonal information
Responsible Party: Jafna L Cox, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01927367    
Other Study ID Numbers: IMPACT-AF-2013
First Submitted: August 20, 2013
First Posted: August 22, 2013
Results First Submitted: April 16, 2020
Results First Posted: September 16, 2020
Last Update Posted: March 9, 2021