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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Usual Care; Other: Specialized outpatient AF Clinic

• Study Type: Interventional
• Enrollment (Actual): 1375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Martini Ziekenhuis
  • Groningen, Netherlands
    • UMCG
  • Haarlem, Netherlands
    • Spaarne Gasthuis
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden
  • Maastricht, Netherlands
    • MUMC+
  • Nijmegen, Netherlands
    • Canisius Wilhelmina Ziekenhuis Nijmegen
  • Zaandam, Netherlands
    • Zaans Medisch Centrum
  • Zwolle, Netherlands
    • Isala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specialized AF-clinic; 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
Active Comparator: Usual Care; Usual care provided by cardiologists at the regular outpatient clinic.	Other: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Bristol-Myers Squibb; Bayer; Pfizer; Boehringer Ingelheim; Daiichi Sankyo, Inc.; Stichting Achmea Gezondheidszor; CZ Fonds; DSW
• Investigators: Principal Investigator: H.J.G.M. Crijns, prof. dr., Maastricht University Medical Center; Principal Investigator: I.C. Van Gelder, prof. dr., UMCG; Principal Investigator: R.G. Tieleman, dr., Martini Ziekenhuis

Publications and helpful links

General Publications

• Wijtvliet EPJP, Tieleman RG, van Gelder IC, Pluymaekers NAHA, Rienstra M, Folkeringa RJ, Bronzwaer P, Elvan A, Elders J, Tukkie R, Luermans JGLM, Van Asselt ADIT, Van Kuijk SMJ, Tijssen JG, Crijns HJGM; RACE 4 Investigators. Nurse-led vs. usual-care for atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):634-641. doi: 10.1093/eurheartj/ehz666.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Integrated chronic care program; specialized outpatient AF clinic; Atrial Fibrillation guideline
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: METC 11-2-099