Larsen Maria Normand, Dreisig Tatjana Sandreva, Rasmussen Maja Kjaer, Christensen Maria Lund, Bjerregaard Daniel, von Sydow Charlotte Demuth, Nielsen Thyge Lynghøj, Fischer Thea
Department of Clinical Research, Nordsjaellands Hospital, Hillerød, Capital Region of Denmark, Denmark
Department of Clinical Research, Nordsjaellands Hospital, Hillerød, Capital Region of Denmark, Denmark.
BMJ Open. 2025 May 14;15(5):e098287. doi: 10.1136/bmjopen-2024-098287.
The combination of a reduction in the Danish hospital bed count, the shortage of hospital staff and demographic changes challenges the Danish hospital capacity. This was further highlighted during the COVID-19 pandemic when hospitals worldwide were overwhelmed by infected patients requiring acute hospital care. To address these challenges, a hospital-at-home (HaH) programme offers an alternative to conventional in-hospital admission. Furthermore, HaH has the potential to improve patient outcomes, reduce costs and increase patient satisfaction. However, few studies have evaluated HaH in a Scandinavian setting, and this article describes the protocol for a randomised controlled trial (RCT) comparing an HaH model with continued conventional in-hospital admission. The main aim of the trial is to evaluate physical activity level and mental wellbeing in patients admitted at home compared with conventionally admitted patients.
110 clinically stable patients from two internal medical wards at Nordsjaellands Hospital in Denmark will be included and randomised in a ratio of 1:1 to either continued conventional in-hospital admission (control group) or virtual HaH model (intervention group). The control group will receive standard hospital treatment, and the intervention group will be transferred home for continued treatment (eg, intravenous antibiotics or oxygen treatment). The primary outcome measures are physical activity assessed using daily step count (during the first 24 hours after inclusion, as an intermediary indicator of the risk of adverse events) and treatment satisfaction (assessed using a patient satisfaction survey). Secondary outcome measures are adverse events of special interest, escalation of care, readmission rate postdischarge (30 days and 90 days), mortality (associated and 7 days, 30 days and 90 days postdischarge), process data (eg, the number of teleconsultations) and a health economic evaluation.
The study was approved by the Danish Research Ethics Committees (no. 2303051) and the Danish Medicines Agency (CIV-23-03-042542) and will be monitored by the Copenhagen University Hospital Good Clinical Practice unit. Results will be published in peer-reviewed journals and presented at relevant national and international conferences. We also plan to communicate the results to relevant stakeholders in the Danish healthcare system.
NCT05920304.
丹麦医院病床数量减少、医院工作人员短缺以及人口结构变化共同对丹麦的医院容量构成挑战。在新冠疫情期间，这一情况进一步凸显，当时全球医院都被需要急性医院护理的感染患者压得不堪重负。为应对这些挑战，一项居家医院（HaH）计划提供了一种替代传统住院治疗的方案。此外，居家医院有潜力改善患者预后、降低成本并提高患者满意度。然而，很少有研究在斯堪的纳维亚背景下评估居家医院，本文描述了一项随机对照试验（RCT）的方案，该试验将一种居家医院模式与持续的传统住院治疗进行比较。该试验的主要目的是评估与传统住院患者相比，居家入院患者的身体活动水平和心理健康状况。
将纳入丹麦北西兰岛医院两个内科病房的110名临床稳定患者，并按1:1的比例随机分为持续传统住院治疗组（对照组）或虚拟居家医院模式组（干预组）。对照组将接受标准的医院治疗，干预组将被转回家中继续治疗（如静脉注射抗生素或吸氧治疗）。主要结局指标是使用每日步数计数评估的身体活动（纳入后前24小时内，作为不良事件风险的中间指标）和治疗满意度（使用患者满意度调查进行评估）。次要结局指标是特别关注的不良事件、护理升级、出院后再入院率（30天和90天）、死亡率（相关死亡率以及出院后7天、30天和90天）、过程数据（如远程会诊次数）以及卫生经济评估。
该研究已获得丹麦研究伦理委员会（编号2303051）和丹麦药品管理局（CIV - 23 - 03 - 042542）的批准，并将由哥本哈根大学医院良好临床实践单位进行监测。研究结果将发表在同行评审期刊上，并在相关的国家和国际会议上展示。我们还计划将研究结果传达给丹麦医疗保健系统的相关利益攸关方。
NCT05920304。
