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Completed

NCT Number: NCT01927367

Integrated Management Program Advancing Community Treatment of Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital District Health Authority, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Decision Support System for AF

Other

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 names: CDSS

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jafna L Cox

Other

Collaborators

  • Bayer
  • McMaster University
  • Population Health Research Institute
  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

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

Acronym: IMPACT-AF

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2013
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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