一项旨在通过在老年人出院期间和出院后针对护理人员的参与来促进预防谵妄的复杂干预措施 - TRADE 项目的研究方案。

A complex intervention to promote prevention of delirium in older adults by targeting caregiver's participation during and after hospital discharge - study protocol of the TRAnsport and DElirium in older people (TRADE) project.

机构信息

Agaplesion Bethesda Clinic Ulm, Zollernring 26, 89073, Ulm, Germany.

Geriatric Center Ulm/ Alb-Donau, Ulm, Germany.

出版信息

BMC Geriatr. 2021 Nov 16;21(1):646. doi: 10.1186/s12877-021-02585-0.

DOI:10.1186/s12877-021-02585-0

PMID:34784883

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8594294/

Abstract

BACKGROUND

Among potentially modifiable risk factors for delirium, transfers between wards, hospitals and other facilities have been mentioned with low evidence. TRADE (TRAnsport and DElirium in older people) was set up to investigate i) the impact of transfer and/or discharge on the onset of delirium in older adults and ii) feasibility and acceptance of a developed complex intervention targeting caregiver's participation during and after hospital discharge or transfer on cognition and the onset of delirium in older adults.

METHODS

The study is designed according to the guidelines of the UK Medical Research Council (MRC) for development and evaluation of complex interventions and comprises two steps: development and feasibility/piloting. The development phase includes i) a multicenter observational prospective cohort study to assess delirium incidence and cognitive decline associated with transfer and discharge, ii) a systematic review of the literature, iii) stakeholder focus group interviews and iv) an expert workshop followed by a Delphi survey. Based on this information, a complex intervention to better and systematically involve family caregivers in discharge and transport was developed. The intervention will be tested in a pilot study using a stepped wedge design with a detailed process and health economic evaluation. The study is conducted at four acute care hospitals in southwest Germany. Primary endpoints are the delirium incidence and cognitive function. Secondary endpoints include prevalence of caregiver companionship, functional decline, cost and cost effectiveness, quality of discharge management and quality of admission management in admitting hospitals or nursing homes. Data will be collected prior to discharge as well as after 3, 7 and 90 days.

DISCUSSION

TRADE will help to evaluate transfer and discharge as a possible risk factor for delirium. In addition, TRADE evaluates the impact and modifiability of caregiver's participation during patient's transfer or discharge on delirium incidence and cognitive decline providing the foundation for a confirmatory implementation study.

TRIAL REGISTRATION

DRKS (Deutsches Register für klinische Studien) DRKS00017828 . Registered on 17th September 2019. Retrospectively registered.

摘要

背景

在可能导致谵妄的可改变风险因素中，转科、转院和其他医疗机构之间的转移被提及，但证据不足。TRADE（老年人转运和谵妄）的设立目的是调查 i）转移和/或出院对老年人谵妄发病的影响，以及 ii）针对住院或转移期间和之后照顾者参与的已开发复杂干预措施的可行性和可接受性，以改善老年人的认知功能和预防谵妄的发生。

方法

该研究根据英国医学研究理事会（MRC）制定的复杂干预措施的发展和评估指南进行设计，包括两个步骤：发展和可行性/试点阶段。发展阶段包括 i）一项多中心前瞻性队列研究，以评估与转移和出院相关的谵妄发生率和认知下降，ii）系统文献回顾，iii）利益相关者焦点小组访谈，以及 iv）专家研讨会，随后进行德尔菲调查。基于这些信息，开发了一种复杂的干预措施，以更好和系统地让家庭照顾者参与出院和转运。该干预措施将在一项试点研究中使用阶梯式楔形设计进行测试，包括详细的过程和健康经济评估。该研究在德国西南部的四家急性护理医院进行。主要终点是谵妄的发生率和认知功能。次要终点包括照顾者陪伴的流行率、功能下降、成本和成本效益、出院管理和入院管理的质量。在出院前以及出院后 3、7 和 90 天收集数据。