Atrial Fibrillation
Conditions
Keywords
nurse, expert program, primary care, implementation, interdisciplinary, effectiveness, disease management system
Brief summary
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.
Interventions
OTHERCare provided by AF expert program
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiovascular events | after 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization days and clinic visits | after 1 year | * 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 |
| Perceived health | After 1 year | Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L) |
| AF related symptoms and symptom burden | After 1 year | AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ) |
| Guideline adherence | after 1 year | * 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) |
| Patient knowledge | After 1 year | The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used. |
| Patient adherence with medication | After 1 year | This will be assessed by self-report using the Dutch version of the 8-item Morisky Medication Adherence Scale (MMAS-8 scale). |
| Time to establishment of a management plan by electrophysiologist or cardiologist | After 1 year | 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. |
| Patient satisfaction | After year | Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS). |
Countries
Belgium
Contacts
Primary ContactDana Berti
Backup ContactHein Heidbuchel
Outcome results
None listed