IntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4

Study Overview
=================
Brief 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.

Official Title
-----------------
IntegRAted Chronic Care Program at a Specialized Atrial Fibrillation (AF) Clinic Versus Usual CarE in Patients With Atrial Fibrillation, an Investigator-initiated, Prospective, Randomised, Open Label, Blinded Outcome Assessment (PROBE) Controlled Multi-center Study

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Specialized outpatient AF Clinic
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed AF detected on electrocardiogram (ECG), holter recordings or event recorder with a duration > 30 seconds, 3 months before inclusion or 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; Age ≥18 years. Exclusion Criteria: No electrocardiographic objectified AF; Unstable heart failure defined as NYHA IV or heart failure necessitating hospital admission < 3 months before inclusion; 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; Untreated hyperthyroidism or < 3 months euthyroidism before inclusion; Foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy; Cardiac surgery ≤ 3 months before inclusion; Planned cardiac surgery; Regular control and treatment, also for AF, at another specialized outpatient cardiac clinic; Patient is not able to fill in the questionnaires; Participation in other clinical study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specialized AF-clinic<br>Management of AF patients in specialized outpatient AF Clinics according to the principles of an integrated chronic care program (ICCP) performed by a nurse practitioner/ physician assistant/ specialised cardiovascular nurse, cardiologist, supported by an ICT decision support tool based on professional guidelines (CardioConsult AF®). 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. In addition, the intervention is based on identifying risk factors and potential problems in patients, and addressing needs through dynamic use of personalized education and adjustment of treatment. | Other: Specialized outpatient AF Clinic<br> <br> |
| Active Comparator: Usual Care<br>Usual care provided by cardiologists at the regular outpatient clinic. | Other: Usual Care<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death. |  | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All components of the primary endpoint |  | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 
| All-cause mortality |  | Minimum of 1 year and a maximum of 5 years and 10 months | 
| Total number of unplanned all-cause hospitalizations |  | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 
| Duration of unplanned all-cause hospitalizations |  | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 
| Total number of unplanned cardiovascular hospitalizations |  | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 
| Duration of unplanned cardiovascular hospitalizations |  | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 
| Total number of unplanned hospitalizations related to atrial fibrillation |  | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 
| Duration of unplanned hospitalizations related to atrial fibrillation |  | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 
| Recurrent unplanned cardiovascular hospitalizations |  | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 
| Costs and cost-effectiveness | Costs, Quality Adjusted Life Years (QALYs) and Cost-effectiveness (Incremental Cost-Effectiveness Ratio - ICER) | baseline, 1 year, 2 years, 3 years | 
| Implementation of care | The extent to which the comprehensive cardiovascular treatment is in accordance with the most recent ESC guidelines Management of Atrial Fibrillation, the HF guidelines of acute and chronic heart failure and the CVD prevention guidelines | Follow up with minimum of 1 year and a maximum of 5 years and 10 months | 
| Patient Quality of life | General health-related QoL is measured by using the SF-36 | Baseline, 1 year, 2 years, 3 years | 
| Patient Quality of life | Patient's perception of severity of arrhythmia-related symptoms is measured by using the AFSS | Baseline, 1 year, 2 years, 3 years | 
| Anxiety and/ or depression | HADS-NL | Baseline, 1 year, 2 years, 3 years | 
| Knowledge of AF | Netherlands Knowledge Scale on AF | Baseline, 1 year, 2 years, 3 years | 
| Compliance to medication | MMAS | Baseline, 1 year, 2 years, 3 years | 
| Compliance to medication | To measure the level of activation of a specific individual the PAM-13 Dutch is used | Baseline, 1 year, 2 years, 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Integrated chronic care program, specialized outpatient AF clinic, Atrial Fibrillation guideline