THISTLE

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

Erik Lenguerrand, Catherine Winter, Karen Innes, Graeme MacLennan, Dimitrios Siassakos, Pauline Lynch, Alan Cameron, Joanna Crofts, Alison McDonald, Kirsty McCormack, Mark Forrest, John Norrie, Siladitya Bhattacharya, Tim Draycott, Thistle group

Research output: Contribution to journalArticle

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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).

Original languageEnglish
Article number294
JournalBMC Pregnancy and Childbirth
Volume17
DOIs
Publication statusPublished - 7 Sep 2017

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Emergencies
Randomized Controlled Trials
Research
Obstetrics
Parturition
Information Services
Apgar Score
Scotland
Pregnancy Outcome
Cesarean Section
Observational Studies
Simulation Training
Logistic Models
Outcome Assessment (Health Care)
Morbidity
Education
Pregnancy
Teacher Training

Keywords

  • Journal Article
  • intrapartum emergencies
  • training course
  • Apgar Score
  • stepped-wedge trial
  • obstetrics

Cite this

THISTLE : trial of hands-on Interprofessional simulation training for local emergencies: a research protocol for a stepped-wedge clustered randomised controlled trial. / Lenguerrand, Erik; Winter, Catherine; Innes, Karen; MacLennan, Graeme; Siassakos, Dimitrios; Lynch, Pauline; Cameron, Alan; Crofts, Joanna; McDonald, Alison; McCormack, Kirsty; Forrest, Mark; Norrie, John; Bhattacharya, Siladitya; Draycott, Tim; Thistle group.

In: BMC Pregnancy and Childbirth, Vol. 17, 294, 07.09.2017.

Research output: Contribution to journalArticle

Lenguerrand, Erik ; Winter, Catherine ; Innes, Karen ; MacLennan, Graeme ; Siassakos, Dimitrios ; Lynch, Pauline ; Cameron, Alan ; Crofts, Joanna ; McDonald, Alison ; McCormack, Kirsty ; Forrest, Mark ; Norrie, John ; Bhattacharya, Siladitya ; Draycott, Tim ; Thistle group. / THISTLE : trial of hands-on Interprofessional simulation training for local emergencies: a research protocol for a stepped-wedge clustered randomised controlled trial. In: BMC Pregnancy and Childbirth. 2017 ; Vol. 17.
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AU - Lenguerrand, Erik

AU - Winter, Catherine

AU - Innes, Karen

AU - MacLennan, Graeme

AU - Siassakos, Dimitrios

AU - Lynch, Pauline

AU - Cameron, Alan

AU - Crofts, Joanna

AU - McDonald, Alison

AU - McCormack, Kirsty

AU - Forrest, Mark

AU - Norrie, John

AU - Bhattacharya, Siladitya

AU - Draycott, Tim

AU - Thistle group

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N2 - 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).

AB - 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).

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KW - intrapartum emergencies

KW - training course

KW - Apgar Score

KW - stepped-wedge trial

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DO - 10.1186/s12884-017-1455-9

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JO - BMC Pregnancy and Childbirth

JF - BMC Pregnancy and Childbirth

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