integrated chronic care program at specialized af clinic versus usual care in patients with atrial fibrillation - race4

Conditions: Atrial Fibrillation

Summary: rationale: the treatment of patients with atrial fibrillation is often inadequate due to poor guideline adherence. an integrated chronic care program (iccp) at a specialized af-clinic was found to be superior to usual care provided by a cardiologist in terms of cardiovascular hospitalizations and cardiovascular mortality. hypothesis: treatment at a specialized af clinic is superior to usual care in terms of cardiovascular mortality and cardiovascular hospitalizations, cost-effectiveness, quality of life and guideline adherence. objectives: primary objective is to show that an iccp reduces cardiovascular hospitalizations and mortality. study design: randomized controlled trial with two study arms: usual care provided by cardiologists (control) versus integrated chronic care program at a specialized af clinic (intervention) in 8 hospitals in the netherlands. the race4 is an event driven study. a total number of 246 events is needed. in total 1716 patients with newly diagnosed af will be included. total duration of the study is 5 years and 10 months with a minimal follow up of 1 year. data is collected at inclusion, after 3, 6, 12 months, every year thereafter and at the end of the study. study population: patients older than 18 year with newly diagnosed af. intervention: the intervention is delivered through the specialized outpatient af clinic. the multidisciplinary team at the af clinic consists of a nurse practitioner or physician assistant or specialised cardiovascular nurse, cardiologist, and is guided by guidelines-based decision support software program based on the applicable esc guideline recommendations. the use of a web-based patient centered management of patient's own medication (medication manager tm) was optional. a standardized diagnostic, treatment and follow-up pathway was performed within the iccp.


Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed af detected on electrocardiogram (ecg), holter recordings or event recorder with a duration \> 30 seconds, 3 months before inclusion or 2. patients with a history of diagnosed af, with no regular control at a cardiologist for af in the last 2 years and referred by a (non-)cardiologic medical specialist for new diagnostics or therapeutic issue; 3. age ≥18 years. exclusion criteria: 1. no electrocardiographic objectified af; 2. unstable heart failure defined as nyha iv or heart failure necessitating hospital admission \< 3 months before inclusion; 3. acute coronary syndrome (acute myocardial infarction or instable angina pectoris, with two of the following characteristics: chest pain and/ or ischemic electrocardiographic changes, and/ or cardiac enzyme rise) \< 3 months before inclusion; 4. untreated hyperthyroidism or \< 3 months euthyroidism before inclusion; 5. foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy; 6. cardiac surgery ≤ 3 months before inclusion; 7. planned cardiac surgery; 8. regular control and treatment, also for af, at another specialized outpatient cardiac clinic; 9. patient is not able to fill in the questionnaires; 10. participation in other clinical study.

Keywords: integrated chronic care program specialized outpatient af clinic atrial fibrillation guideline