Integrated Management Program Advancing Community Treatment of Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Clinical Decision Support System for AF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinical Decision Support System for AF<br>Providers randomized to use the Clinical Decision Support System (CDSS, a web-based tool). | Other: Clinical Decision Support System for AF<br>* 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.<br>* Other names: CDSS;|
| No Intervention: Usual Care<br>Usual Care - providers are not eligible to access / use the CDSS. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With AF-related Emergency Department Visits | Individual element of primary outcome. AF-related emergency department visits. | 12 months | 
| Process of Care | Timely access to specialist consultation Timely access to echocardiograms Timely access to catheter ablations for AF and atrial flutter | 12 months | 
| Health Related Quality of Life | - Health Related Quality of Life measured using an accepted health questionnaire (EQ-5D-5L). | 12 months | 
| Costs | The costs associated with the development, implementation, and maintenance of CDSS. The costs associated with managing and treating patients with AF. | 12 months | 
| Cost Effectiveness | - Incremental cost effectiveness ratio between the interventional arm and the control arm | 12 months | 
| Number of Participations With CV Hospitalizations | Individual element of primary outcome. AF-related emergency department visits. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Decision Support System, Primary Health Care, Clinical Practice Guidelines