Dataset Information

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.

SUBMITTER: van Tetering AAC

PROVIDER: S-EPMC7388496 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Publications

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

van Tetering A A C AAC van Meurs A A Ntuyo P P van der Hout-van der Jagt M B MB Mulders L G M LGM Nolens B B Namagambe I I Nakimuli A A Byamugisha J J Oei S G SG

BMC pregnancy and childbirth 20200728 1

<h4>Background</h4>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 simulati ...[more]

PMID: 32723330

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Project description:BackgroundDespite many efforts, long wait times and overcrowding in emergency departments (EDs) have remained a significant health service issue in Canada. For several years, Canada has had one of the longest wait times among the Organisation for Economic Co-operation and Development countries. From a patient's perspective, this challenge has been described as "patients wait in pain or discomfort for hours before being seen at EDs." To overcome the challenge of increased wait times, we developed an innovative ED management platform called SurgeCon that was designed based on continuous quality improvement principles to maintain patient flow and mitigate the impact of patient surge on ED efficiency. The SurgeCon quality improvement intervention includes a protocol-driven software platform, restructures ED organization and workflow, and aims to establish a more patient-centric environment. We piloted SurgeCon at an ED in Carbonear, Newfoundland and Labrador, and found that there was a 32% reduction in ED wait times.ObjectiveThe primary objective of this trial is to determine the effects of SurgeCon on ED performance by assessing its impact on length of stay, the time to a physician's initial assessment, and the number of patients leaving the ED without being seen by a physician. The secondary objectives of this study are to evaluate SurgeCon's effects on patient satisfaction and patient-reported experiences with ED wait times and its ability to create better-value care by reducing the per-patient cost of delivering ED services.MethodsThe implementation of the intervention will be assessed using a comparative effectiveness-implementation hybrid design. This type of hybrid design is known to shorten the amount of time associated with transitioning interventions from being the focus of research to being used for practice and health care services. All EDs with 24/7 on-site physician support (category A hospitals) will be enrolled in a 31-month, pragmatic, stepped wedge cluster randomized trial. All clusters (hospitals) will start with a baseline period of usual care and will be randomized to determine the order and timing of transitioning to intervention care until all hospitals are using the intervention to manage and operationalize their EDs.ResultsData collection for this study is continuing. As of February 2022, a total of 570 randomly selected patients have participated in telephone interviews concerning patient-reported experiences and patient satisfaction with ED wait times. The first of the 4 EDs was randomly selected, and it is currently using SurgeCon's eHealth platform and applying efficiency principles that have been learned through training since September 2021. The second randomly selected site will begin intervention implementation in winter 2022.ConclusionsBy assessing the impact of SurgeCon on ED services, we hope to be able to improve wait times and create better-value ED care in this health care context.Trial registrationClinicalTrials.gov NCT04789902; https://clinicaltrials.gov/ct2/show/NCT04789902.International registered report identifier (irrid)DERR1-10.2196/30454.

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Project description:BackgroundSimulation-based training is a common strategy for improving the quality of facility-based maternity services and is often evaluated using Kirkpatrick's theoretical model. The results on the Kirkpatrick levels are closely related to the quality of the instructional design of a training program. The instructional design is generally defined as the "set of prescriptions for teaching methods to improve the quality of instruction with a goal of optimizing learning outcomes."ObjectiveThe aim of this study is to evaluate the instructional design of a technology-enhanced simulation-based training in obstetrics, the reaction of participants, and the effect on knowledge, teamwork, and skills in a low-income country.MethodsA stepped-wedge cluster randomized trial was performed in a university hospital in Kampala, Uganda, with an annual delivery volume of over 31,000. In November 2014, a medical simulation center was installed with a full-body birthing simulator (Noelle S550, Gaumard Scientific), an interactive neonate (Simon S102 Newborn CPR Simulator, Gaumard Scientific), and an audio and video recording system. Twelve local obstetricians were trained and certified as medical simulation trainers. From 2014 to 2016, training was provided to 57 residents in groups of 6 to 9 students. Descriptive statistics were calculated for ten instructional design features of the training course measured by the 42-item ID-SIM (Instructional Design of a Simulation Improved by Monitoring). The Wilcoxon signed rank test was conducted to investigate the differences in scores on knowledge, the Clinical Teamwork Scale, and medical technical skills.ResultsThe mean scores on the ten instructional design features ranged from 54.9 (95% CI 48.5-61.3) to 84.3 (95% CI 80.9-87.6) out of 100. The highest mean score was given on the feature feedback and the lowest scores on repetitive practice and controlled environment. The overall score for the training day was 92.8 out of 100 (95% CI 89.5-96.1). Knowledge improved significantly, with a test score of 63.4% (95% CI 60.7-66.1) before and 78.9% (95% CI 76.8-81.1) after the training (P<.001). The overall score on the 10-point Clinical Teamwork Scale was 6.0 (95% CI 4.4-7.6) before and 5.9 (95% CI 4.5-7.2) after the training (P=.78). Medical technical skills were scored at 55.5% (95% CI 47.2-63.8) before and 65.6% (95% CI 56.5-74.7) after training (P=.08).ConclusionsMost instructional design features of a technology-enhanced simulation-based training in obstetrics in a low-income country were scored high, although intervals were large. The overall score for the training day was high, and knowledge did improve after the training program, but no changes in teamwork and (most) medical technical skills were found. The lowest-scored instructional design features may be improved to achieve further learning aims.Trial registrationISRCTN Registry ISRCTN98617255; http://www.isrctn.com/ISRCTN98617255.International registered report identifier (irrid)RR2-10.1186/s12884-020-03050-3.

Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

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