Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices.

Official Title
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Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Care provided by AF expert program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Every newly diagnosed AF patient. Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion. AF must be confirmed on electrocardiogram. Capable of providing written informed consent. Dutch speaking and verbally testable, without cognitive impairment. Exclusion Criteria: AF patients who once received an arrhythmologic consult about AF prior to the start of the study. AF patients who have a systematic follow-up at a cardiologist prior to the start of the study. Terminally ill AF patients Participation in another clinical trial

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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No

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 |
| --- | --- |
| Experimental: AF expert program<br>Care provided by the interdisciplinary, nurse-coordinated AF expert program | Other: Care provided by AF expert program<br> <br> |
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular events | Combined endpoint of cardiovascular hospitalizations, cardiovascular deaths and unplanned cardiovascular visits. Cardiac death: Cardiac arrhythmic, Cardiac non-arrhythmic, Vascular non cardiac Cardiovascular hospitalization: Arrhythmic events (AF, syncope, sustained ventricular tachycardia, cardiac arrest), Heart Failure, Acute myocardial infarction, Stroke, Systemic embolism, Major bleeding, Life-threatening effects of drugs Unplanned cardiovascular visits | after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Guideline adherence | Does the medical record report a formal CHA2DS2-VASc score, HAS-BLED bleeding risk score and EHRA score? Does the medical record report an appropriate prescription of antithrombotic treatment. Does the medical record report an appropriate application of rate and rhythm (not if asymptomatic, if contraindicated and not in patients with permanent AF) Does the medical record report an appropriate upstream therapy? (For example in heart failure patients, is the heart failure treated) | after 1 year | 
| Hospitalization days and clinic visits | Number of outpatient (internal or neurological) clinic visits per year Number of emergency room visits per year due to AF Number of hospitalization days due to AF Number of hospitalization days for cardiovascular reasons Number of hospitalization days on intensive care due to AF | after 1 year | 
| Perceived health | Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L) | After 1 year | 
| AF related symptoms and symptom burden | AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ) | After 1 year | 
| Patient satisfaction | Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS). | After year | 
| Patient knowledge | The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used. | After 1 year | 
| Patient adherence with medication | This will be assessed by self-report using the Dutch version of the 8-item Morisky Medication Adherence Scale (MMAS-8 scale). | After 1 year | 
| Time to establishment of a management plan by electrophysiologist or cardiologist | This outcome will be searched for by reviewing medical records of, or by interviewing, all participating patients at 1, 3, 6 months and 1 year. | After 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implementation, interdisciplinary, effectiveness, disease management system, nurse, expert program, primary care