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

NCT01740037 | Completed DMC

• 1 other identifier: METC 11-2-099
• Study Type: interventional
• Target: 1,375
• Locations: 1 country
• Sites: 8

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.

Conditions

Atrial Fibrillation

Keywords

Integrated chronic care program; specialized outpatient AF clinic; Atrial Fibrillation guideline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

Study Arms (2)

Specialized AF-clinic

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Usual care provided by cardiologists at the regular outpatient clinic.

Other: Usual Care

Interventions

Specialized outpatient AF Clinic OTHER

Specialized AF-clinic

Usual Care OTHER

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No electrocardiographic objectified AF;
• Foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy;
• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Stichting Achmea Gezondheidszor: collaborator
• DSW: collaborator
• CZ Fonds: collaborator
• Bayer: collaborator
• Boehringer Ingelheim: collaborator
• Bristol-Myers Squibb: collaborator
• Pfizer: collaborator
• Daiichi Sankyo: collaborator

Study Sites (8)

Martini Ziekenhuis

Groningen, Netherlands

Location

UMCG

Groningen, Netherlands

Location

Spaarne Gasthuis

Haarlem, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

MUMC+

Maastricht, Netherlands

Location

Canisius Wilhelmina Ziekenhuis Nijmegen

Nijmegen, Netherlands

Location

Zaans Medisch Centrum

Zaandam, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31544925 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• H.J.G.M. Crijns, prof. dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• I.C. Van Gelder, prof. dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• R.G. Tieleman, dr.

  Martini Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: December 4, 2012
• Study Start: December 1, 2012
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: May 28, 2019

Record last verified: 2019-04

Locations

NL (8)