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BMC Pregnancy Childbirth. 2017 Sep 7;17(1):294. doi: 10.1186/s12884-017-1455-9.

THISTLE: trial of hands-on Interprofessional simulation training for local emergencies: a research protocol for a stepped-wedge clustered randomised controlled trial.

Author information

1
School of Clinical Sciences, University of Bristol, Level 1 Learning and Research, Southmead Hospital, Bristol, BS10 5NB, UK.
2
PROMPT Maternity Foundation: registered charity in England & Wales, No:1140557, London, UK.
3
Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, AB25 2ZD, UK.
4
North Bristol Trust, Department of Women's Health, The Chilterns, Southmead Hospital, Bristol, BS10 5NB, UK.
5
NHS Tayside, Maternity Unit, Ninewells Hospital and Medical School, Dundee, DD2 1UB, UK.
6
Ian Donald Fetal Medicine Centre, Queen Elizabeth University Hospital, G51 4TF, Glasgow, UK.
7
Edinburgh Clinical Trials Unit, University of Edinburgh, Western General Hospital, Edinburgh, EH4 2XU, UK.
8
Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, AB25 2ZD, UK.
9
PROMPT Maternity Foundation: registered charity in England & Wales, No:1140557, London, UK. tdraycott@me.com.
10
North Bristol Trust, Department of Women's Health, The Chilterns, Southmead Hospital, Bristol, BS10 5NB, UK. tdraycott@me.com.
11
School of Social and Community Medicine, University of Bristol, Department of Women's Health, The Chilterns, Southmead Hospital, Bristol, BS10 5NB, UK. tdraycott@me.com.

Abstract

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 <7 at 5 min for term vaginal or emergency caesarean section births (≥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.

TRIAL REGISTRATION:

ISRCTN11640515 (registered on 09/09/2013).

KEYWORDS:

Apgar score; Intrapartum emergencies; Obstetrics; Stepped-wedge trial; Training course

PMID:
28882116
PMCID:
PMC5590181
DOI:
10.1186/s12884-017-1455-9
[Indexed for MEDLINE]
Free PMC Article

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