Integrated management of atrial fibrillation including tailoring of anticoagulation in primary care: study design of the ALL-IN cluster randomised trial
| Autor: | Henk J. G. Bilo, Frans H. Rutten, Sjef J C M van de Leur, Ruud Oudega, Carline J. van den Dries, Karel G.M. Moons, Arno W. Hoes, Geert-Jan Geersing, Arif Elvan |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Cost-Benefit Analysis integrated management Hemorrhage Primary care 030204 cardiovascular system & hematology Nurse's Role Secondary Care primary care 03 medical and health sciences 0302 clinical medicine Informed consent Cause of Death Health care Protocol medicine Clinical endpoint Humans atrial fibrillation 030212 general & internal medicine anticoagulation Intensive care medicine Integrated management Aged Netherlands Medicine(all) Primary Health Care Delivery of Health Care Integrated business.industry Anticoagulants Atrial fibrillation General Medicine medicine.disease Comorbidity Hospitalization Stroke comorbidity Research Design Heart failure Quality of Life Interdisciplinary Communication Medical emergency General practice / Family practice business |
| Zdroj: | BMJ open [E], 7(9). BMJ Publishing Group BMJ Open |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2016-015510 |
| Popis: | IntroductionIn our ageing society, we are at the merge of an expected epidemic of atrial fibrillation (AF). AF management requires an integrated approach, including rate or rhythm control, stroke prevention with anticoagulation and treatment of comorbidities such as heart failure or type 2 diabetes. As such, primary care seems to be the logical healthcare setting for the chronic management of patients with AF. However, primary care has not yet played a dominant role in AF management, which has been in fact more fragmented between different healthcare providers. This fragmentation might have contributed to high healthcare costs. To demonstrate the feasibility of managing AF in primary care, studies are needed that evaluate the safety and (cost-)effectiveness of integrated AF management in primary care.Methods and analysisThe ALL-IN trial is a multicentre, pragmatic, cluster randomised, non-inferiority trial performed in primary care practices in a suburban region in the Netherlands. We aim to include a minimum of 1000 patients with AF aged 65 years or more from around 18 to 30 practices. Duration of the study is 2 years. Practices will be randomised to either the intervention arm (providing integrated AF management, involving a trained practice nurse and collaboration with secondary care) or the control arm (care as usual). The primary endpoint is all-cause mortality. Secondary endpoints are cardiovascular mortality, (non)-cardiovascular hospitalisation, major adverse cardiac events, stroke, major bleeding, clinically relevant non-major bleeding, quality of life and cost-effectiveness.Ethics and disseminationThe protocol was approved by the Medical Ethical Committee of the Isala Hospital Zwolle, the Netherlands. Patients in the intervention arm will be asked informed consent for participating in the intervention. Results are expected in 2019 and will be disseminated through both national and international journals and conferences.Trial registration numberThis trial is registered at the Netherlands Trial Register (NTR5532). |
| Databáze: | OpenAIRE |
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