Jahn Johannes, Wild Eva-Maria
Hamburg Center for Health Economics, University of Hamburg, Hamburg, Germany.
School of Economic Disciplines, University of Siegen, Siegen, Germany.
Trials. 2025 Sep 16;26(1):340. doi: 10.1186/s13063-025-09072-6.
Ageing populations and the increasing prevalence of chronic diseases pose major challenges to health care systems in high-income countries, especially in rural areas affected by a decline in public services. This trial investigates a new short-stay hospital model, STATAMED, which adopts a general medical approach to addressing the needs of adult patients (18 years or older) with chronic diseases and/or acute infections, with a particular focus on the elderly. STATAMED short-stay wards will incorporate a mandatory case review between the referring physician and the lead STATAMED physician, as well as support from case managers and mobile nurses to ensure coordination and continuity of care after hospital discharge. The primary aim of the trial is to determine whether the care provided in STATAMED wards is more effective than usual hospital care in improving the combined primary outcome of hospital length of stay and 30-day hospital readmission rates.
The study will be conducted as a prospective, cluster-randomised controlled trial using a stepped-wedge design. STATAMED wards will be implemented at six hospital sites, and the catchment areas will be divided into clusters. All referring entities in a catchment area-including general practitioners (GPs), office-based specialists, nursing homes, ambulatory care services, and emergency services-will be potential candidates for cluster formation. The intervention group is expected to consist of 4481 patients. Primary and secondary outcomes will be assessed using claims data from participating statutory health insurers. A health economic evaluation will also be conducted using these data to compare costs associated with STATAMED and usual care. To minimise the risk of bias, analyses will be conducted on both an intention-to-treat and actual treatment basis.
This trial will assess whether STATAMED improves health care utilisation outcomes that reflect the efficiency and quality of inpatient care and discharge planning compared to usual hospital care. The findings will provide novel evidence about how best to improve health care for patients with chronic diseases and/or acute infections and may offer evidence for cost-effective strategies to improve health care delivery.
German Clinical Trials Register DRKS00033096. Registered on 27 November 2023, last updated on 26 May 2025.
人口老龄化以及慢性病患病率的不断上升给高收入国家的医疗保健系统带来了重大挑战，尤其是在受公共服务下降影响的农村地区。本试验研究了一种新的短期住院医院模式STATAMED，该模式采用综合医疗方法来满足患有慢性病和/或急性感染的成年患者（18岁及以上）的需求，特别关注老年人。STATAMED短期病房将包括转诊医生和STATAMED主治医生之间的强制性病例审查，以及病例管理人员和流动护士的支持，以确保出院后护理的协调和连续性。该试验的主要目的是确定STATAMED病房提供的护理在改善住院时间和30天再入院率这一综合主要结局方面是否比常规医院护理更有效。
本研究将采用前瞻性、整群随机对照试验，采用阶梯楔形设计。STATAMED病房将在六个医院地点实施，集水区将被划分为各个群组。集水区内的所有转诊机构，包括全科医生（GP）、门诊专科医生、养老院、门诊护理服务机构和急救服务机构，都将是群组形成的潜在候选对象。干预组预计将包括4481名患者。主要和次要结局将使用参与法定健康保险公司的理赔数据进行评估。还将使用这些数据进行健康经济评估，以比较与STATAMED和常规护理相关的成本。为了尽量减少偏倚风险，将在意向性治疗和实际治疗基础上进行分析。
本试验将评估与常规医院护理相比，STATAMED是否能改善反映住院护理效率和质量以及出院计划的医疗保健利用结局。研究结果将为如何最好地改善慢性病和/或急性感染患者的医疗保健提供新的证据，并可能为改善医疗保健服务的具有成本效益的策略提供证据。
德国临床试验注册中心DRKS00033096。于2023年11月27日注册，最后更新于2025年5月26日。
