多病症患者跨部门护理的个性化、跨学科患者路径(eliPfad试验):一项随机对照试验的研究方案

Personalized, interdisciplinary patient pathway for cross-sector care of multimorbid patients (eliPfad trial): study protocol for a randomized controlled trial.

作者信息

Lindemann Christoph Heinrich, Burst Volker, Völker Linus Alexander, Brähler Sebastian, Simic Dusan, Becker Ingrid, Hellmich Martin, Kurscheid Clarissa, Scholten Nadine, Krauspe Ruben, Leibel Kerstin, Stock Stephanie, Brinkkoetter Paul Thomas

机构信息

Department II of Internal Medicine and Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine, University of Cologne, University Hospital Cologne, Cologne, Germany.

Cologne Institute for Health Economics and Clinical Epidemiology, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.

出版信息

Trials. 2024 Mar 11;25(1):177. doi: 10.1186/s13063-024-08026-8.

Abstract

BACKGROUND

Multimorbid and frail elderly patients often carry a high burden of treatment. Hospitalization due to the onset of an acute illness can disrupt the fragile balance, resulting in further readmissions after hospital discharge. Current models of care in Germany do not meet the needs of this patient group. Rather lack of coordination and integration of care combined with a lack of interdisciplinary approaches result in fragmented and inadequate care and increase the burden of treatment even more.

METHODS

eliPfad is a randomized controlled trial conducted in 6 hospitals in Germany. Multimorbid elderly patients aged 55 or older are randomly assigned to the intervention or control group. Patients in the intervention group receive the eliPfad intervention additional to standard care. The core components of eliPfad are: Early assessment of patients' individual treatment burden and support through a specially trained case manager Involvement of the patient's general practitioner (GP) right from the beginning of the hospital stay Preparation of an individual, cross-sectoral treatment plan through the interdisciplinary hospital team with the involvement of the patient's GP Establishment of a cross-sectoral electronic patient record (e-ePA) for documentation and cross-sectoral exchange Support/Promote patient adherence Tailored early rehabilitation during the hospital stay, which is continued at home Close-tele-monitoring of medically meaningful vital parameters through the use of tablets, digital devices, and personal contacts in the home environment The intervention period begins in the hospital and continues 6 weeks after discharge. Patients in the control group will be treated according to standard clinical care and discharged according to current discharge management. The primary aim is the prevention/reduction of readmissions in the first 6 months after discharge. In addition, the impact on health-related quality of life, the burden of treatment, survival, self-management, medication prescription, health literacy, patient-centered care, cost-effectiveness, and process evaluation will be examined. Nine hundred forty-eight patients will be randomized 1:1 to intervention and control group.

DISCUSSION

If eliPfad leads to fewer readmissions, proves (cost-)effective, and lowers the treatment burden, it should be introduced as a new standard of care in the German healthcare system.

TRIAL REGISTRATION

The trial was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) on 08/14/2023 under the ID DRKS00031500 .

摘要

背景

患有多种疾病且身体虚弱的老年患者往往承受着沉重的治疗负担。因急性疾病发作而住院可能会打破这种脆弱的平衡,导致出院后再次入院。德国目前的护理模式无法满足这一患者群体的需求。护理缺乏协调与整合,再加上缺乏跨学科方法,导致护理碎片化且不充分,进一步加重了治疗负担。

方法

eliPfad是在德国6家医院进行的一项随机对照试验。年龄在55岁及以上的患有多种疾病的老年患者被随机分配到干预组或对照组。干预组患者在接受标准护理的基础上还接受eliPfad干预。eliPfad的核心组成部分包括:通过经过专门培训的病例管理员对患者的个体治疗负担进行早期评估并提供支持;从住院一开始就让患者的全科医生(GP)参与进来;由跨学科医院团队在患者的全科医生参与下制定个性化的跨部门治疗计划;建立跨部门电子患者记录(e-ePA)用于记录和跨部门交流;支持/促进患者依从性;在住院期间进行量身定制的早期康复,并在家中继续进行;通过使用平板电脑、数字设备以及在家中进行个人联系,对具有医学意义的重要参数进行密切远程监测。干预期从住院开始,出院后持续6周。对照组患者将按照标准临床护理进行治疗,并根据当前的出院管理进行出院。主要目标是预防/减少出院后前6个月内的再次入院情况。此外,还将研究对健康相关生活质量、治疗负担、生存率、自我管理、药物处方、健康素养、以患者为中心的护理、成本效益和过程评估的影响。948名患者将按1:1随机分配到干预组和对照组。

讨论

如果eliPfad能减少再次入院情况,证明具有(成本)效益,并降低治疗负担,那么它应作为德国医疗保健系统中的一种新护理标准被引入。

试验注册

该试验于2023年8月14日在德国临床试验注册中心(Deutsches Register Klinischer Studien (DRKS))注册,注册号为DRKS00031500。

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