|- candidate number||23631|
|- NTR Number||NTR5532|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jan-2016|
|- Secondary IDs||NL53065.075.15 ABR NL-dossier number|
|- Public Title||Integral management of the heart rhythm disorder atrial fibrillation, including stroke prevention with blood thinners and care for comorbidities, by the practice nurse and general practitioner in primary care|
|- Scientific Title||Management of Atrial fibriLLation INcluding tailoring of anticoagulation in patients from primary care|
|- hypothesis||The hypothesis of this study is that integral AF management in primary care - including case-management for anticoagulation (stroke prevention) as well as appropriate attention given to all cardiac and non-cardiac comorbidities - is at least non-inferior and likely improves patient care in elderly AF patients, as compared to usual care. |
|- Healt Condition(s) or Problem(s) studied||Atrial Fibrillation, Anticoagulants, Co-morbidity|
|- Inclusion criteria||Participating primary care practices need to be willing and able to provide integral management to their AF patients.
Patients aged 65 years or over of participating practices with documented AF are eligible for participation if they do not meet any of the exclusion criteria.|
|- Exclusion criteria||Unwillingness to provide informed consent by the participating general practitioners is the only exclusion criterion for primary care practices in this study. |
Patients are not eligible for this study if
a) they have a life expectancy shorter than 3 months,
b) if their age at baseline is below 65 years,
c) if they have an Internal Cardioverter Defibrillator (ICD) or a Cardiac Resynchronisation Therapy (CRT) device,
d) if they had cardiac resynchronization treatment, cardiac ablation or cardiac surgery less than 3 months prior to inclusion or one of these procedures planned,
e) if they had heart valve surgery in the past or are known with a rheumatic mitral valve stenosis,
f) if they had pulmonary vein isolation (PVI) in the past or have a PVI planned,
g) if they are legally incapable of providing informed consent for the intervention program,
h) if they participate in another randomized trial on AF.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||26-jan-2016|
|- planned closingdate||1-aug-2018|
|- Target number of participants||1000|
|- Interventions||Patients from primary care practices randomized to the intervention arm will receive integral AF management, consisting of a) visits to the practice nurse three times a year and once yearly to the general practitioner, b) INR measurements performed by the practice nurse (for which the practice nurse will be trained), and c) easy access consultation from secondary care through the establishment of an Expert Center for Anticoagulation and an Expert Center Cardiology. |
Patients from practices randomized to the control arm will receive care as usual by the Dutch Thrombosis Service, cardiologist and/or general practitioner.
|- Primary outcome||All-cause mortality|
|- Secondary outcome||Cardiovascular mortality, cardiovascular and non-cardiovascular hospitalization, Major Adverse Cardiac Events (MACE), stroke, major bleeding, quality of life and cost-effectiveness.|
|- Timepoints||24 months.|
|- Trial web site||www.juliuscentrum.nl/all-in|
|- CONTACT FOR PUBLIC QUERIES||MD, MSc C.J. van den Dries|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.J. Geersing|
|- Sponsor/Initiator ||Isala Clinics Zwolle, Julius Center for Health Sciences and Primary Care|
(Source(s) of Monetary or Material Support)
|Stichting Achmea Gezondheidszorg (SAG), Roche Diagnostics, Hein Hogerzeil Stichting|
|- Brief summary||Background & Aim: Atrial fibrillation (AF) is the most common cardiac arrhythmia with an increased risk of stroke and mortality. It often involves frail, elderly patients, requiring adequate care for comorbidities, lifestyle and tailored anticoagulation treatment. Given the expected increase in prevalence in the next couple of years, transition of care for AF patients from secondary care to primary care is desired. However, data on the safety and (cost)effectiveness are lacking. This study evaluates if integral management of patients with AF by the practice nurse and general practitioner, including care for comorbidities and anticoagulation, is non-inferior to usual care.|
Method: The ALL-IN study is a cluster randomized trial performed in approximately 60 primary care practices in the region of Zwolle, The Netherlands, with more than 1000 AF patients aged 65 years or over. Patients from primary care practices randomized to the intervention arm will receive integral AF management, consisting of a) visits to the practice nurse three times a year and once yearly to the general practitioner, b) INR measurements performed by the practice nurse, and c) easy access consultation from secondary care through the establishment of an Expert Center for Anticoagulation and an Expert Center Cardiology. Patients from practices randomized to the control arm will receive care as usual by the Dutch Thrombosis Service, cardiologist and/or general practitioner.
Results: The study will start in 2016 with a follow-up time of 24 months. Primary endpoint is all-cause mortality. Secondary endpoints are cardiovascular mortality, (non)cardiovascular hospitalization, Major Adverse Cardiac Events (MACE), stroke, major bleeding, quality of life and cost-effectiveness.
Conclusions: The ALL-IN trial is the scientific evaluation of a health care innovation that – due to the delegation of tasks to the practice nurse and the establishment of the Expert Centers for Anticoagulation and Cardiology– aims for sustainable and accessible care, close to the AF patient.
|- Main changes (audit trail)|
|- RECORD||20-jan-2016 - 1-jul-2016|