Clinical trial NCT01740037: IntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Integrated chronic care program
specialized outpatient AF clinic
Atrial Fibrillation guideline
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Achmea Gezondheidszor
name: DSW
name: CZ Fonds
name: Bayer
name: Boehringer Ingelheim
name: Bristol-Myers Squibb
name: Pfizer
name: Daiichi Sankyo
First posted: 2012-12-04
Enrollment: 1375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death.
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary outcomes:
measure: All components of the primary endpoint
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
measure: All-cause mortality
timeFrame: Minimum of 1 year and a maximum of 5 years and 10 months
measure: Total number of unplanned all-cause hospitalizations
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
measure: Duration of unplanned all-cause hospitalizations
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
measure: Total number of unplanned cardiovascular hospitalizations
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
measure: Duration of unplanned cardiovascular hospitalizations
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
measure: Total number of unplanned hospitalizations related to atrial fibrillation
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
measure: Duration of unplanned hospitalizations related to atrial fibrillation
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
measure: Recurrent unplanned cardiovascular hospitalizations
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
measure: Costs and cost-effectiveness
timeFrame: baseline, 1 year, 2 years, 3 years
measure: Implementation of care
timeFrame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
measure: Patient Quality of life
timeFrame: Baseline, 1 year, 2 years, 3 years
measure: Patient Quality of life
timeFrame: Baseline, 1 year, 2 years, 3 years
measure: Anxiety and/ or depression
timeFrame: Baseline, 1 year, 2 years, 3 years
measure: Knowledge of AF
timeFrame: Baseline, 1 year, 2 years, 3 years
measure: Compliance to medication
timeFrame: Baseline, 1 year, 2 years, 3 years
measure: Compliance to medication
timeFrame: Baseline, 1 year, 2 years, 3 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Groningen
country: Netherlands
facility: UMCG
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Maastricht
country: Netherlands
facility: MUMC+
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis Nijmegen
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: Maastricht University Medical Center
name: H.J.G.M. Crijns, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: UMCG
name: I.C. Van Gelder, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Martini Ziekenhuis
name: R.G. Tieleman, dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.