The THISTLE Stepped-Wedge Design Randomised Controlled Trial
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ORIGINAL RESEARCH BMJ Qual Saf: first published as 10.1136/bmjqs-2018-008625 on 13 July 2019. Downloaded from 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 Draycott1,2 5mins ► Additional material is ABSTRACT effect on the rate of Apgar <7 in Scotland during the published online only. To view Objective To assess whether the implementation of study period. Local implementation at scale was found please visit the journal online an intrapartum training package (PROMPT (PRactical to be more difficult than anticipated. Further research (http:// dx. doi. org/ 10. 1136/ Obstetric Multi-Professional Training)) across a health is required to understand why the positive effects bmjqs- 2018- 008625). service reduced the proportion of term babies born with observed in other single-unit studies have not been 5mins For numbered affiliations see Apgar score <7 at 5 min (<7 ). replicated in Scottish maternity units, and how units can end of article. Design Stepped-wedge cluster randomised controlled be best supported to locally implement the intervention trial. authentically and effectively. Correspondence to Setting Twelve randomised maternity units with ≥900 Trial registration number ISRCTN11640515. Dr Erik Lenguerrand, births/year in Scotland. Three additional units were Translational Health Sciences, included in a supplementary analysis to assess the effect University of Bristol, Bristol BS8 across Scotland. The intervention commenced in March 1TH, UK; 2014 with follow-up until September 2016. erik. lenguerrand@ bristol. ac. uk INTRODUCTION http://qualitysafety.bmj.com/ Intervention The PROMPT training package (Second 1–3 Maternity care in the UK could be safer. edition), with subsequent unit-level implementation of Received 23 July 2018 Perinatal outcomes are substantially Revised 19 June 2019 PROMPT courses for all maternity staff. 4 Accepted 24 June 2019 Main outcome measures The primary outcome was worse than in countries of similar GDP the proportion of term babies with Apgar<75mins. and more than 50% of adverse pregnancy Results 87 204 eligible births (99.2% with an Apgar outcomes are considered preventable.5–7 score), of which 1291 infants had an Apgar<75mins were Training for intrapartum emergen- delivered in the 12 randomised maternity units. Two cies has been recommended to improve units did not implement the intervention. The overall 3–6 8–10 5mins care and mandated by litigation Apgar<7 rate observed in the 12 randomised units 11 12 was 1.49%, increasing from 1.32% preintervention to authorities but data regarding effec- on September 26, 2021 by guest. Protected copyright. 1.59% postintervention. Once adjusted for a secular tive intrapartum training are conflicting. time trend, the ’intention-to-treat’ analysis indicated Some training programmes have been a moderate but non-significant reduction in the rate associated with significant safety improve- of term babies with an Apgar scores <75mins following ments,13–18 whereas other initiatives have PROMPT training (OR=0.79 95%CI(0.63 to 1.01)). reported either no change16 19 or a dete- However, some units implemented the intervention rioration in outcomes.15 Observational earlier than their allocated step, whereas others studies of a multiprofessional intra- © Author(s) (or their delayed the intervention. The content and authenticity employer(s)) 2019. Re-use of the implemented intervention varied widely at unit partum emergencies training course for permitted under CC BY-NC. No level. When the actual date of implementation of the local maternity staff—PRactical Obstetric commercial re-use. See rights intervention in each unit was considered in the analysis, Multi-Professional Training—(PROMPT, and permissions. Published by there was no evidence of improvement (OR=1.01 Bristol, UK) have previously demonstrated BMJ. (0.84 to 1.22)). No intervention effect was detected by improved compliance with clinical stan- To cite: Lenguerrand E, broadening the analysis to include all 15 large Scottish dards,13 17 reductions in clinical error14 Winter C, Siassakos D, et al. maternity units. Units with a history of higher rates of 5mins and sustainable improvements in perinatal BMJ Qual Saf Epub ahead of Apgar<7 maintained higher Apgar rates during the 20 print: [please include Day study (OR=2.09 (1.28 to 3.41)) compared with units with outcomes. These positive effects were Month Year]. doi:10.1136/ pre-study rates aligned to the national rate. initially observed in a single maternity unit bmjqs-2018-008625 Conclusions PROMPT training, as implemented, had no but have since been repeated across other Lenguerrand E, et al. BMJ Qual Saf 2019;0:1–13. doi:10.1136/bmjqs-2018-008625 1 Original research BMJ Qual Saf: first published as 10.1136/bmjqs-2018-008625 on 13 July 2019. Downloaded from international settings.21–23 Although these early data are (SW-RCT). This was viewed as the safest, most prag- extremely encouraging, it is important to determine matic and ethical option, with the additional rigour of whether these improvements could be replicated at randomisation. scale across a national health system using a robust study The study comprised a control period when none of design such as a randomised controlled trial (RCT). the units received training, three intervention periods, With over 50 000 births annually,24 Scotland and at least two follow-up periods (figure 1). Four provided an ideal setting to investigate the effect of maternity units were randomised to each interven- implementing PROMPT training at national scale. tion step. Each period lasted 6 months to allow all 12 Only 3 of the 15 Scottish maternity units (≥900 births units to receive their intervention within 18 months. annually—2012) had previously undertaken PROMPT This would reduce potential contamination between training. Moreover, all NHS maternity outcomes trained and untrained units (rotation of trained staff are routinely collated centrally by the Information between units) within the pragmatic funding and time Statistics Division Scotland (ISD), providing a robust constraints. data set for analysis. Finally, the proportion of term Maternity units in NHS Scotland with ≥900 births/ babies with Apgar <7 at 5 min (Apgar<75mins),25 an year (n=15) that had not previously participated in the outcome that has previously been shown to be reduced PROMPT T3 programme were eligible (n=12) and following PROMPT training, was higher in Scotland invited to participate through the Scottish Committee 13 than in other settings (1.19% between 2004 and of the Royal College of Obstetricians and Gynaecolo- 2009, data from ISD Scottish Morbidity Record (SMR gists. The three units that had already been conducting 02). PROMPT training prior to this study were included in The aim of this study was to conduct an RCT to a supplementary preplanned analysis to assess the inter- investigate whether the implementation of an intra- vention at national scale. Units with <900 births/year partum emergencies training package across all large were excluded (<6% of births between 01/01/2000 maternity units within an entire health service could and 30/09/2013), as their staffing structures may have reduce the proportion of term babies with an Apgar differed from the larger units. Babies born preterm, 5mins score <7 . at home, at other hospitals and then transferred to a participating unit were all excluded, as were those METHODS confirmed to have an intrauterine death prior to The protocol for this trial has been published previ- labour. Babies born by elective caesarean section (CS) ously.26 were also excluded as their care was not impacted by Intervention the intrapartum training provided by PROMPT. The The intervention was the PROMPT training package first four participating maternity units attended a T3 http://qualitysafety.bmj.com/ (Second edition), which included a 2 day PROMPT programme in March 2014. The 6-month period Train the Trainers (T3) programme (TIDieR check- preceding the start of the first intervention period list, online supplementary appendix 1), with subse- (‘Intervention 1’) (01/10/2013–01/04/2014) was iden- quent unit-level implementation of local PROMPT tified as the control period (‘Control’). The study courses for all maternity staff. PROMPT courses are ended with the completion of the last follow-up period ‘in-house’, adaptable multiprofessional training days (‘Follow-up period 2’) on the 30/09/2016. which cover the management of core obstetric emer- gencies, including postpartum haemorrhage, sepsis and Randomisation, concealment and blinding shoulder dystocia as well as fetal monitoring in labour on September 26, 2021 by guest. Protected copyright. One eligible maternity unit that had attended and team-working. Each participating maternity unit PROMPT T3 training before the start of the study identified a multiprofessional ‘in-house’ training team but had not commenced ‘in-house’ local PROMPT (recommended: two midwives, one obstetrician and courses, was allocated to period 1 for inclusion in the one anaesthetist) to attend the T3 programme at The study. The remaining participating units were allocated Scottish Clinical Simulation Centre in Larbert, before to an intervention period using the ‘imbalance statistic’ the start of their allocated intervention step. The T3 29 30 programme included a demonstration ‘PROMPT method to balance units by size (small, medium, Course’ and a T3 day to guide ‘in house’ trainers in large annual births). An independent statistician from how to use the PROMPT Course-in-a-Box (Second the Centre for Healthcare Randomised Trials (CHaRT) Edition) and set up local PROMPT courses.27 28 The randomly selected an allocation sequence list from a ‘in-house’ trainers were asked to implement local subset with the most desirable balance properties using PROMPT courses, aiming to train all their maternity computer-generated random numbers.