LMU Munich, Department of Health Services Management, Schackstraße 4, 80539 Munich, Germany.
AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.
Contemp Clin Trials. 2021 Apr;103:106297. doi: 10.1016/j.cct.2021.106297. Epub 2021 Jan 27.
A lack of effective coordination and communication between ambulatory care physicians and hospitals, including the lack of follow-up care, poses a challenge to the recovery process of patients suffering from cardiac disease, often resulting in rehospitalisation and adverse outcomes. This innovative care programme aims to bridge the gap between ambulatory and hospital care. A key element of this programme is specifically trained care managers (Cardiolotse) who provide post-discharge support, access to additional resources and help the patient to navigate successfully through the healthcare system.
The study is set up as a prospective, randomised, controlled trial. Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation. Sample size calculations resulted in 1454patients per group after adjusting for potential non-compliance. All participants are surveyed at discharge, after 3 and 12 months. The primary outcome of the study is the 12-month rehospitalisation rate. Secondary outcomes include differences in length of hospital stay, mortality, quality-adjusted life years, costs and patient satisfaction. Statistical analysis and economic evaluation will be complemented by a process evaluation.
The new healthcare programme is designed to support patients when leaving hospital with cardiac conditions by easing the transition between sectors through access to Cardiolotses and individualised care plans. We hypothesise that the programme reduces rehospitalisation and improves clinically relevant patient outcomes.
German Clinical Trial Register, DRKS00020424. Registered 2020-06-18, http://www.drks.de/DRKS00020424.
门诊医生和医院之间缺乏有效的协调和沟通，包括缺乏后续护理，这对心脏病患者的康复过程构成了挑战，常常导致再次住院和不良后果。这个创新的护理项目旨在弥合门诊和医院护理之间的差距。该项目的一个关键要素是专门培训的护理经理（Cardiolotse），他们提供出院后的支持、获得额外资源的机会，并帮助患者成功地在医疗保健系统中导航。
该研究采用前瞻性、随机、对照试验设计。采用区组随机化方法，按照 1:1 的分配比例将患者分配到干预组（护理经理支持）和对照组（常规护理）。经过潜在不依从性调整后，每组样本量计算为 1454 例患者。所有参与者在出院时、出院后 3 个月和 12 个月进行调查。研究的主要结局是 12 个月的再住院率。次要结局包括住院时间、死亡率、质量调整生命年、成本和患者满意度的差异。统计分析和经济评估将辅以过程评估。
新的医疗保健计划旨在通过为 Cardiolotses 和个体化护理计划提供便利，支持患有心脏病的患者在出院后获得护理，从而缓解部门之间的过渡。我们假设该计划可降低再住院率并改善临床相关的患者结局。
德国临床试验注册处，DRKS00020424。注册于 2020 年 6 月 18 日，网址：http://www.drks.de/DRKS00020424。
