Integrated Management Program Advancing Community Treatment of Atrial Fibrillation
IMPACT-AF
1 other identifier
interventional
1,145
1 country
2
Brief Summary
Research Question: Among community-based patients with AF, does providing an integrated Clinical Decision Support System (CDSS) to providers and patients improve process of care and clinical outcomes, and decrease the healthcare costs and resource utilization over 12 months, as compared to usual care? Intervention: A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines, to support primary care providers and patients in optimizing and standardizing AF care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Sep 2013
Longer than P75 for not_applicable atrial-fibrillation
2 active sites
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
August 20, 2013
CompletedFirst Posted
Study publicly available on registry
August 22, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedResults Posted
Study results publicly available
September 16, 2020
CompletedMarch 9, 2021
February 1, 2021
5.2 years
August 20, 2013
April 16, 2020
February 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits
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.
12 months
Secondary Outcomes (6)
Number of Participants With AF-related Emergency Department Visits
12 months
Process of Care
12 months
Health Related Quality of Life
12 months
Costs
12 months
Cost Effectiveness
12 months
- +1 more secondary outcomes
Other Outcomes (1)
Number of Participants With Major Bleeding
12 months
Study Arms (2)
Clinical Decision Support System for AF
OTHERProviders randomized to use the Clinical Decision Support System (CDSS, a web-based tool).
Usual Care
NO INTERVENTIONUsual Care - providers are not eligible to access / use the CDSS.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age \>/= 18 years (no max age limit)
- Confirmed atrial fibrillation.
- Able to provide informed consent in English.
You may not qualify if:
- Patients unable to provide informed consent.
- Patients who are not expected to be alive at the end of the 12 month follow up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jafna L Coxlead
- McMaster Universitycollaborator
- Population Health Research Institutecollaborator
- St. Joseph's Healthcare Hamiltoncollaborator
- Bayercollaborator
Study Sites (2)
Capital District Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Related Publications (6)
Hamlin J, Cox J, Hamilton L, Nemis-White J, McKillop J, Sandila N, Parkash R. Regional Disparities in Atrial Fibrillation Management: An IMPACT-AF Substudy. CJC Open. 2024 Jul 3;6(10):1162-1169. doi: 10.1016/j.cjco.2024.06.010. eCollection 2024 Oct.
PMID: 39525336DERIVEDCox J, Hamilton L, Thabane L, Foster G, MacKillop J, Xie F, Ciaccia A, Choudhri S, Nemis-White J, Parkash R; IMPACT-AF Investigators. Computerized clinical decision support to improve stroke prevention therapy in primary care management of atrial fibrillation: a cluster randomized trial. Am Heart J. 2024 Jul;273:102-110. doi: 10.1016/j.ahj.2024.04.016. Epub 2024 Apr 28.
PMID: 38685464DERIVEDHumphries B, Cox JL, Parkash R, Thabane L, Foster GA, MacKillop J, Nemis-White J, Hamilton L, Ciaccia A, Choudhri SH, Kovic B, Xie F. Resource use and cost associated with computerized decision support system and usual care in managing patients with atrial fibrillation: analysis of IMPACT-AF randomized trial data. BMC Med Inform Decis Mak. 2023 Oct 18;23(1):228. doi: 10.1186/s12911-023-02329-7.
PMID: 37853351DERIVEDNemis-White JM, Hamilton LM, Shaw S, MacKillop JH, Parkash R, Choudhri SH, Ciaccia A, Xie F, Thabane L, Cox JL; IMPACT-AF Investigators. Lessons learned from Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): a pragmatic clinical trial of computerized decision support in primary care. Trials. 2021 Aug 11;22(1):531. doi: 10.1186/s13063-021-05488-y.
PMID: 34380542DERIVEDHumphries B, Cox JL, Parkash R, Thabane L, Foster GA, MacKillop J, Nemis-White J, Hamilton L, Ciaccia A, Choudhri SH, Xie F; IMPACT-AF Investigators. Patient-Reported Outcomes and Patient-Reported Experience of Patients With Atrial Fibrillation in the IMPACT-AF Clinical Trial. J Am Heart Assoc. 2021 Aug 3;10(15):e019783. doi: 10.1161/JAHA.120.019783. Epub 2021 Jul 28.
PMID: 34315232DERIVEDCox JL, Parkash R, Abidi SS, Thabane L, Xie F, MacKillop J, Abidi SR, Ciaccia A, Choudhri SH, Abusharekh A, Nemis-White J; IMPACT-AF Investigators. Optimizing primary care management of atrial fibrillation: The rationale and methods of the Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) study. Am Heart J. 2018 Jul;201:149-157. doi: 10.1016/j.ahj.2018.04.008. Epub 2018 Apr 7.
PMID: 29807323DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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
Results Point of Contact
- Title
- Dr. Jafna L Cox
- Organization
- QEII Health Sciences Centre, Halifax, Nova Scotia
Study Officials
- PRINCIPAL INVESTIGATOR
Jafna L Cox, MD, FRCPC, FACC
CDHA
- STUDY DIRECTOR
Syed Sibte Raza Abidi, MSc, PhD
Dalhousie University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Staff Cardiologist
Study Record Dates
First Submitted
August 20, 2013
First Posted
August 22, 2013
Study Start
September 1, 2013
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
March 9, 2021
Results First Posted
September 16, 2020
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) is not available due to ethics regulations.