THISTLE: trial of hands-on Interprofessional simulation training for local emergencies: a research protocol for a stepped-wedge clustered randomised controlled trial
THISTLE: trial of hands-on Interprofessional simulation training for local emergencies: a research protocol for a stepped-wedge clustered randomised controlled trial
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DOI：
10.1186/s12884-017-1455-9
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发表时间：
2017-09-07
影响因子：
3.1
通讯作者：
Draycott, Tim
中科院分区：
文献类型：
--
作者：
Lenguerrand, Erik;Winter, Catherine;Draycott, Tim
背景：在英国，许多不良妊娠结局可以通过更好的产时护理来预防。人们广泛建议进行分娩期间紧急情况的培训，但关于其有效性的数据相互矛盾。观察性研究表明，持续的地方改善围产期的结果与使用实用产科多专业培训-（PROMPT）培训包。然而，这种影响需要在随机研究设计的背景下进行研究，而不是在热情的早期采用者单中心。本研究的主要目的是确定PROMPT的有效性，以减少出生低APGAR scores.Methods的足月婴儿的比率：THISTLE（试验动手跨专业的模拟培训，当地的紧急情况）是一个多中心的阶梯楔形集群随机对照优势试验，在苏格兰的12个大型妇产科单位进行。根据之前的观察结果，所有单位都接受了干预，并被随机分成四个单位一组，分配到三个干预时间段之一，每个干预时间段间隔六个月。来自每个参与单位的四名多专业临床医生组成的团队在开始分配的干预步骤之前参加了为期两天的PROMPT培训师培训（T3）计划。在T3培训之后，各小组在分配的干预期开始之前，开始在各自的单位开展当地分娩期紧急培训。由于干预的性质，无法设盲。这项研究的目的是在每个单位开始当地课程后至少12个月内对其进行跟踪。研究的主要结局是每个研究单位中Apgar评分（≥ 37周）的比例。这些数据将从信息服务部苏格兰Moreover Record 02中提取，这是一项关于妊娠和出生的国家常规数据收集。混合或边际logistic回归将采用的主要analysis.Discussion：THISTLE是第一步楔形群随机试验，以评估分娩期间的紧急情况培训计划的有效性。评估结果将为今后的培训、教员和政策提供信息。
Background: Many adverse pregnancy outcomes in the UK could be prevented with better intrapartum care. Training for intrapartum emergencies has been widely recommended but there are conflicting data about their effectiveness. Observational studies have shown sustained local improvements in perinatal outcomes associated with the use of the PRactical Obstetric Multi-Professional Training -(PROMPT) training package. However this effect needs to be investigated in the context of randomised study design in settings other than enthusiastic early adopter single-centres. The main aim of this study is to determine the effectiveness of PROMPT to reduce the rate of term infants born with low APGAR scores.Methods: THISTLE (Trial of Hands-on Interprofessional Simulation Training for Local Emergencies) is a multi-centre stepped-wedge clustered randomised controlled superiority trial conducted across 12 large Maternity Units in Scotland. On the basis of prior observational findings all Units have been offered the intervention and have been randomly allocated in groups of four Units, to one of three intervention time periods, each six months apart. Teams of four multi-professional clinicians from each participating Unit attended a two-day PROMPT Train the Trainers (T3) programme prior to the start of their allocated intervention step. Following the T3 training, the teams commenced the implementation of local intrapartum emergency training in their own Units by the start of their allocated intervention period. Blinding has not been possible due to the nature of the intervention. The aim of the study is to follow up each Unit for at least 12-months after they have commenced their local courses. The primary outcome for the study is the proportion of Apgar scores = 37 weeks) occurring in each of the study Units. These data will be extracted from the Information Services Division Scottish Morbidity Record 02, a national routine data collection on pregnancy and births. Mixed or marginal logistic regression will be employed for the main analysis.Discussion: THISTLE is the first stepped wedge cluster randomised trial to evaluate the effectiveness of an intrapartum emergencies training programme. The results will inform training, trainers and policy going forward.