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Study protocol training for life: a stepped wedge cluster randomized trial about emergency obstetric simulation-based training in a low-income country.

Abstract：

BACKGROUND:Globally perinatal and maternal mortality rates remain unacceptably high. There is increasing evidence that simulation-based training in obstetric emergencies is associated with improvement in clinical outcomes. However, the results are not entirely consistent. The need for continued research in a wide variety of clinical settings to establish what works, where and why was recommended. The aim of this study is to investigate the effectiveness of an emergency obstetric simulation-based training program with medical technical and teamwork skills on maternal and perinatal mortality in a low-income country. METHODS:A stepped wedge cluster randomized trial will be conducted at the medium to high-risk labour ward at Mulago Hospital, Kampala, Uganda, with an annual delivery rate of over 23,000. The training will be performed using a train-the-trainers model in which training is cascaded down from master trainers to local facilitators (gynaecologists) to learners (senior house officers). Local facilitators will be trained during a four-day train-the-trainers course with an annual repetition. The senior house officers will be naturally divided in seven clusters and randomized for the moment of training. The training consists of a one-day, monodisciplinary, simulation-based training followed by repetition training sessions. Scenarios are based on the main local causes of maternal and neonatal mortality and focus on both medical technical and crew resource management skills. Kirkpatrick's classification will be used to evaluate the training program. Primary outcome will be the composite of maternal and neonatal mortality ratios. Secondary outcome will comprise course perception, evaluation of the instructional design of the training, knowledge, technical skills, team performance, percentage of ventouse deliveries, percentage of caesarean sections, and a Weighted Adverse Outcome Score. DISCUSSION:This stepped wedge cluster randomized trial will investigate the effect of a monodisciplinary simulation-based obstetric training in a low-income country, focusing on both medical technical skills and crew resource management skills, on patient outcome at one of the largest labour wards worldwide. We will use a robust study design which will allow us to better understand the training effects, and difficulties in evaluating training programs in low-income countries. TRIAL REGISTRATION:ISRCTN98617255 , retrospectively registered July 23, 2018.

journal_name

BMC Pregnancy Childbirth

journal_title

BMC pregnancy and childbirth

authors

van Tetering AAC,van Meurs A,Ntuyo P,van der Hout-van der Jagt MB,Mulders LGM,Nolens B,Namagambe I,Nakimuli A,Byamugisha J,Oei SG

doi

10.1186/s12884-020-03050-3

subject

Has Abstract

pub_date

2020-07-28 00:00:00

pages

429

issue

issn

1471-2393

pii

10.1186/s12884-020-03050-3

journal_volume

pub_type

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Study protocol training for life: a stepped wedge cluster randomized trial about emergency obstetric simulation-based training in a low-income country.