van den Dries Carline J, Oudega Ruud, Elvan Arif, Rutten Frans H, van de Leur Sjef J C M, Bilo Henk J G, Hoes Arno W, Moons Karel G M, Geersing Geert-Jan
Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, The Netherlands.
Department of Cardiology, Isala Hospital Zwolle, Zwolle, The Netherlands.
BMJ Open. 2017 Sep 18;7(9):e015510. doi: 10.1136/bmjopen-2016-015510.
In 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.
The 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.
The 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.
This trial is registered at the Netherlands Trial Register (NTR5532).
在我们这个老龄化社会，我们正处于预计会出现的心房颤动（房颤）流行的交汇点。房颤管理需要一种综合方法，包括心率或节律控制、通过抗凝预防中风以及治疗心力衰竭或2型糖尿病等合并症。因此，初级保健似乎是房颤患者长期管理的合理医疗环境。然而，初级保健在房颤管理中尚未发挥主导作用，实际上，房颤管理在不同医疗服务提供者之间更为分散。这种分散可能导致了高昂的医疗成本。为了证明在初级保健中管理房颤的可行性，需要开展研究来评估初级保健中综合房颤管理的安全性和（成本）效益。
ALL-IN试验是一项在荷兰一个郊区的初级保健机构中进行的多中心、实用、整群随机、非劣效性试验。我们的目标是从约18至30个机构中纳入至少1000名65岁及以上的房颤患者。研究持续时间为2年。机构将被随机分配到干预组（提供综合房颤管理，包括一名经过培训的执业护士并与二级保健机构合作）或对照组（常规护理）。主要终点是全因死亡率。次要终点包括心血管死亡率、（非）心血管住院、主要不良心脏事件、中风、大出血、临床相关非大出血、生活质量和成本效益。
该方案已获得荷兰兹沃勒伊萨拉医院医学伦理委员会的批准。将要求干预组的患者签署参与干预的知情同意书。预计2019年得出结果，并将通过国内和国际期刊及会议进行传播。
该试验已在荷兰试验注册中心（NTR5532）注册。
