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Randomized Controlled Trial
. 2020 Feb;29(2):122-134.
doi: 10.1136/bmjqs-2018-008625. Epub 2019 Jul 13.

Effect of hands-on interprofessional simulation training for local emergencies in Scotland: the THISTLE stepped-wedge design randomised controlled trial

Erik Lenguerrand  1 , Cathy Winter  2 , Dimitrios Siassakos  3 , Graeme MacLennan  4 , Karen Innes  4 , Pauline Lynch  5 , Alan Cameron  6 , Joanna Crofts  2 , Alison McDonald  4 , Kirsty McCormack  4 , Mark Forrest  4 , John Norrie  7 , Siladitya Bhattacharya  8 , Tim Draycott  9   2
Affiliations
Randomized Controlled Trial

Effect of hands-on interprofessional simulation training for local emergencies in Scotland: the THISTLE stepped-wedge design randomised controlled trial

Erik Lenguerrand et al. BMJ Qual Saf. 2020 Feb.

Abstract

Objective: To assess whether the implementation of an intrapartum training package (PROMPT (PRactical Obstetric Multi-Professional Training)) across a health service reduced the proportion of term babies born with Apgar score <7 at 5 min (<75mins).

Design: Stepped-wedge cluster randomised controlled trial.

Setting: Twelve randomised maternity units with ≥900 births/year in Scotland. Three additional units were included in a supplementary analysis to assess the effect across Scotland. The intervention commenced in March 2014 with follow-up until September 2016.

Intervention: The PROMPT training package (Second edition), with subsequent unit-level implementation of PROMPT courses for all maternity staff.

Main outcome measures: The primary outcome was the proportion of term babies with Apgar<75mins.

Results: 87 204 eligible births (99.2% with an Apgar score), of which 1291 infants had an Apgar<75mins were delivered in the 12 randomised maternity units. Two units did not implement the intervention. The overall Apgar<75mins rate observed in the 12 randomised units was 1.49%, increasing from 1.32% preintervention to 1.59% postintervention. Once adjusted for a secular time trend, the 'intention-to-treat' analysis indicated a moderate but non-significant reduction in the rate of term babies with an Apgar scores <75mins following PROMPT training (OR=0.79 95%CI(0.63 to 1.01)). However, some units implemented the intervention earlier than their allocated step, whereas others delayed the intervention. The content and authenticity of the implemented intervention varied widely at unit level. When the actual date of implementation of the intervention in each unit was considered in the analysis, there was no evidence of improvement (OR=1.01 (0.84 to 1.22)). No intervention effect was detected by broadening the analysis to include all 15 large Scottish maternity units. Units with a history of higher rates of Apgar<75mins maintained higher Apgar rates during the study (OR=2.09 (1.28 to 3.41)) compared with units with pre-study rates aligned to the national rate.

Conclusions: PROMPT training, as implemented, had no effect on the rate of Apgar <75mins in Scotland during the study period. Local implementation at scale was found to be more difficult than anticipated. Further research is required to understand why the positive effects observed in other single-unit studies have not been replicated in Scottish maternity units, and how units can be best supported to locally implement the intervention authentically and effectively.

Trial registration number: ISRCTN11640515.

Keywords: apgar score; intrapartum emergencies; obstetrics; stepped-wedge trial; training course.

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Conflict of interest statement

Competing interests: EL is an employee of the University of Bristol which receives funding from PROMPT charity to pay part of EL’s salary. CW is seconded from North Bristol NHS Trust as the Lead Research Midwife to the PROMPT charity. DS is an invited member of GLOBE, an initiative funded by Ferring. TD is a Trustee of the PROMPT Maternity Foundation charity, which provides PROMPT Training. He is a consultant for Limbs & Things and Laerdal and paid speaker for Ferring Pharmaceuticals. CW, DS and JC are members of the PROMPT Maternity Foundation charity. The remaining authors have no competing interests.

Figures

Figure 1
Figure 1
Consort flow diagram of the Thistle Stepped-Wedge trial. A more detailed Consort flow diagram is provided in online supplementary appendix 4.
Figure 2
Figure 2
Apgar<75 mins prevalence rates by maternity units and study time periods, randomisation schedule and actual intervention implementation.
See this image and copyright information in PMC

Comment in

References

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