多中心、实用、整群随机对照试验，比较标准化腹膜透析（PD）培训与常规护理对 PD 相关感染的影响（TEACH-PD 试验）：试验方案。
Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol.
机构信息
South Western Sydney Local Health District, Liverpool, NSW, Australia.
Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia.
出版信息
Trials. 2023 Nov 14;24(1):730. doi: 10.1186/s13063-023-07715-0.
BACKGROUND
Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability of PD. Accordingly, PD-related infection is the top-priority research outcome for patients and caregivers. While PD nurse trainers teach patients to perform their own PD, PD training curricula are not standardized or informed by an evidentiary base and may offer a potential approach to prevent PD infections. The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial evaluates whether a standardized training curriculum for PD nurse trainers and incident PD patients based on the International Society for Peritoneal Dialysis (ISPD) guidelines reduces PD-related infections compared to usual training practices.
METHODS
The TEACH-PD trial is a registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial. TEACH-PD will recruit adults aged 18 years or older who have not previously undergone PD training at 42 PD treatment units (clusters) in Australia and New Zealand (ANZ) between July 2019 and June 2023. Clusters will be randomized 1:1 to standardized TEACH-PD training curriculum or usual training practice. The primary trial outcome is the time to the first occurrence of any PD-related infection (exit site infection, tunnel infection, or peritonitis). The secondary trial outcomes are the individual components of the primary outcome, infection-associated catheter removal, transfer to hemodialysis (greater than 30 days and 180 days), quality of life, hospitalization, all-cause death, a composite of transfer to hemodialysis or all-cause death, and cost-effectiveness. Participants are followed for a minimum of 12 months with a targeted average follow-up period of 2 years. Participant and outcome data are collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and the New Zealand Peritoneal Dialysis (NZPD) Registry. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
DISCUSSION
TEACH-PD is a registry-based, cluster-randomized pragmatic trial that aims to provide high-certainty evidence about whether an ISPD guideline-informed standardized PD training curriculum for PD nurse trainers and adult patients prevents PD-related infections.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03816111. Registered on 24 January 2019.
背景
腹膜透析（PD）相关感染，如腹膜炎、出口部位和隧道感染，严重影响 PD 的可持续性。因此，PD 相关感染是患者和护理人员最关注的研究结果。虽然 PD 护士培训师教导患者进行自身 PD，但 PD 培训课程没有标准化，也没有循证依据，可能为预防 PD 感染提供一种潜在方法。以国际腹膜透析学会（ISPD）指南为基础，针对 PD 护士培训师和新开始 PD 的患者的靶向教育方法改善 PD 结局（TEACH-PD）试验评估了这种标准化培训课程是否可降低 PD 相关感染的发生率，与常规培训实践相比。
方法
TEACH-PD 试验是一项基于注册的、实用的、开放性、多中心、两国、集群随机对照试验。TEACH-PD 将在 2019 年 7 月至 2023 年 6 月期间在澳大利亚和新西兰（ANZ）的 42 个 PD 治疗单位（集群）招募年龄在 18 岁或以上、以前未接受 PD 培训的成年人。集群将以 1:1 的比例随机分配到标准化的 TEACH-PD 培训课程或常规培训实践中。主要试验结局是首次发生任何 PD 相关感染（出口部位感染、隧道感染或腹膜炎）的时间。次要试验结局是主要结局的各个组成部分、感染相关的导管移除、转为血液透析（大于 30 天和 180 天）、生活质量、住院、全因死亡、血液透析或全因死亡的复合结局以及成本效益。参与者至少随访 12 个月，目标平均随访期为 2 年。参与者和结局数据从澳大利亚和新西兰透析和移植登记处（ANZDATA）和新西兰腹膜透析登记处（NZPD）收集。本方案遵循标准干预试验建议报告条目（SPIRIT）指南。
讨论
TEACH-PD 是一项基于注册的、集群随机实用试验，旨在提供高确定性证据，证明针对 PD 护士培训师和成年患者的 ISPD 指南指导的标准化 PD 培训课程是否可预防 PD 相关感染。
试验注册
ClinicalTrials.gov NCT03816111。于 2019 年 1 月 24 日注册。
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