University Palliative Center, University Hospital Carl Gustav Carus, TU Dresden, Fetscherstraße 74, 01307, Dresden, Germany.
Department of Psychooncology, National Center for Tumor Diseases (NCT/UCC), Fetscherstraße 74, 01307, Dresden, Germany.
BMC Palliat Care. 2022 May 2;21(1):62. doi: 10.1186/s12904-022-00955-y.
Although the majority of German patients in a palliative state prefer to die at home, the actual place of death is most often a hospital. Unplanned hospital readmissions (UHA) not only contradict most patients' preferences but also increase the probability of an aggressive end-of-life treatment. As limited knowledge is available which factors contribute to an UHA, the PRePP-project aims to explore predictors related to informal caregivers (IC) as well as medical and structural factors.
This prospective, observational, mono-centric study will assess structural and medical factors as well as ICs' psychological burden throughout seven study visits. Starting in April 2021 it will consecutively include 240 patients and their respective IC if available. Standardized measures concerning ICs' Quality of Life (WHOQOL-BREF), psychological distress (NCCN-Distress Thermometer), anxiety (GAD-7) and depressiveness (PHQ-9) will be assessed. If participants prefer, assessment via phone, browser-based or paper-based will be conducted. Medical records will provide routinely assessed information concerning patient-related characteristics such as gender, age, duration of hospital stay and medical condition. Nurse-reported data will give information on whether hospitalization and death occurred unexpectedly. Data will be progressed pseudonymized. Multivariable regression models will help to identify predictors of the primary endpoint "unplanned hospital admissions".
The PRePP-project is an important prerequisite for a clinical risk assessment of UHAs. Nevertheless, it faces several methodological challenges: as it is a single center study, representativity of results is limited while social desirability might be increased as the study is partly conducted by the treatment team. Furthermore, we anticipated an underrepresentation of highly burdened participants as they might refrain from participation.
This study was retrospectively registered 19 October 2021 at clinicaltrials.gov (NCT05082389). https://clinicaltrials.gov/ct2/show/NCT05082389.
尽管大多数处于临终阶段的德国患者更愿意在家中离世，但实际上他们的死亡地点往往是医院。非计划性医院再入院（UHA）不仅违背了大多数患者的意愿，还增加了接受激进临终治疗的可能性。由于目前对于导致 UHA 的因素知之甚少，因此 PRePP 项目旨在探索与非专业照护者（IC）以及医疗和结构因素相关的预测因素。
这是一项前瞻性、观察性、单中心研究，将在七次研究访视中评估结构和医疗因素以及 IC 的心理负担。该研究从 2021 年 4 月开始，将连续纳入 240 名患者及其各自的 IC（如果有）。将评估 IC 的生活质量（WHOQOL-BREF）、心理困扰（NCCN-痛苦温度计）、焦虑（GAD-7）和抑郁（PHQ-9）等标准化指标。如果参与者愿意，也可以通过电话、基于浏览器或纸质方式进行评估。病历将提供有关患者相关特征的常规评估信息，例如性别、年龄、住院时间和医疗状况。护士报告的数据将提供有关住院和死亡是否意外发生的信息。数据将以化名方式进行处理。多变量回归模型将有助于确定“非计划性医院入院”这一主要结局的预测因素。
PRePP 项目是 UHA 临床风险评估的重要前提。然而，它面临着一些方法学挑战：由于这是一项单中心研究，因此结果的代表性有限，而由于研究部分由治疗团队进行，可能会增加社会期望。此外，我们预计高负担的参与者会代表性不足，因为他们可能会拒绝参与。
本研究于 2021 年 10 月 19 日在 clinicaltrials.gov 上进行了回顾性注册（NCT05082389）。[注册链接]
