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

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.

Conditions

• Atrial Fibrillation

Interventions

OTHER

Specialized outpatient AF Clinic

OTHER

Usual Care

Sponsors & Collaborators

• Stichting Achmea Gezondheidszor

  collaborator OTHER

• DSW

  collaborator UNKNOWN

• CZ Fonds

  collaborator OTHER

• Bayer

  collaborator INDUSTRY

• Boehringer Ingelheim

  collaborator INDUSTRY

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Pfizer

  collaborator INDUSTRY

• Daiichi Sankyo

  collaborator INDUSTRY

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• H.J.G.M. Crijns, prof. dr. · Maastricht University Medical Center

• I.C. Van Gelder, prof. dr. · UMCG

• R.G. Tieleman, dr. · Martini Ziekenhuis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2018-09-30

Completion

2018-09-30

Countries

• Netherlands

Study Locations