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

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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

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Clinical Decision Support System for AF Not Applicable

Detailed Description:

Atrial fibrillation (AF) is the most common abnormality of cardiac rhythm. It is also a disease of aging, affecting 3% of adults aged > 45 years and 12% of those aged > 75. Individually, AF's rapid and irregular heart beat is most frequently perceived as undesirable palpitations, but more threatening impacts are heart failure, catastrophic stroke and premature death. AF also markedly impairs quality of life.

Although patients with AF are at increased risk of stroke, death and hospitalization, many patients are not benefiting from evidence-informed, best-care strategies. Gaps have been documented in the knowledge, skills and competencies of primary care clinicians concerning the management of AF in Canada. For example, a large proportion of AF patients at moderate to high risk for stroke do not receive guideline recommended thromboprophylaxis; and of those that do, many are not optimally controlled. One Canadian study also found that in patient with known AF and a prior stroke, who were then admitted with a second stroke, 15% were not on any anticoagulation and only 18% were on warfarin and within the therapeutic range. Opportunities certainly exist to enhance the uptake of the Canadian AF Clinical Practice Guideline recommendations and best-care approaches in the primary care setting.

Patients need to be the focus of care services and be actively engaged and empowered to manage their care, with the support of health care providers. We believe that health system efficiency, care quality and patient safety can be enhanced through the use of innovative, integrated, interactive, pro-active and personalized point-of- care solutions targeting both providers and patients. This is the premise for the IMPACT-AF study.

Primary care providers and their patients are anticipated to benefit from enhanced use of health information technology regarding the management of patients with AF. A clinical guideline-based decision support system (CDSS) will be developed and tested in primary care settings across Nova Scotia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF)
Actual Study Start Date : September 2013
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Clinical Decision Support System for AF
Providers randomized to use the Clinical Decision Support System (CDSS, a web-based tool).
Other: 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.
Other Name: CDSS

No Intervention: Usual Care
Usual Care - providers are not eligible to access / use the CDSS.



Primary Outcome Measures :
  1. Number of Participants With Cardiovascular Hospitalization and AF-related Emergency Department Visits [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With AF-related Emergency Department Visits [ Time Frame: 12 months ]
    • Individual element of primary outcome.
    • AF-related emergency department visits.

  2. Process of Care [ Time Frame: 12 months ]
    • Timely access to specialist consultation
    • Timely access to echocardiograms
    • Timely access to catheter ablations for AF and atrial flutter

  3. Health Related Quality of Life [ Time Frame: 12 months ]
    - Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L).

  4. Costs [ Time Frame: 12 months ]
    • The costs associated with the development, implementation, and maintenance of CDSS.
    • The costs associated with managing and treating patients with AF.

  5. Cost Effectiveness [ Time Frame: 12 months ]
    - Incremental cost effectiveness ratio between the interventional arm and the control arm

  6. Number of Participations With CV Hospitalizations [ Time Frame: 12 months ]
    • Individual element of primary outcome.
    • AF-related emergency department visits.


Other Outcome Measures:
  1. Number of Participants With Major Bleeding [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >/= 18 years (no max age limit)
  • Confirmed atrial fibrillation.
  • Able to provide informed consent in English.

Exclusion Criteria:

  • Patients unable to provide informed consent.
  • Patients who are not expected to be alive at the end of the 12 month follow up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927367


Locations
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Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Jafna L Cox
McMaster University
Population Health Research Institute
St. Joseph's Healthcare Hamilton
Bayer
Investigators
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Principal Investigator: Jafna L Cox, MD, FRCPC, FACC CDHA
Study Director: Syed Sibte Raza Abidi, MSc, PhD Dalhousie University
  Study Documents (Full-Text)

Documents provided by Jafna L Cox, Nova Scotia Health Authority:
Statistical Analysis Plan  [PDF] January 9, 2019
Study Protocol  [PDF] September 26, 2017

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jafna L Cox, Staff Cardiologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01927367    
Other Study ID Numbers: IMPACT-AF-2013
First Posted: August 22, 2013    Key Record Dates
Results First Posted: September 16, 2020
Last Update Posted: March 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) is not available due to ethics regulations.
Keywords provided by Jafna L Cox, Nova Scotia Health Authority:
Clinical Decision Support System
Primary Health Care
Clinical Practice Guidelines
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes