Plain English Summary
Background and study aims
Safety in labour is a priority for women, their families, staff and the NHS, but unfortunately UK maternity care is not as safe as it could and should be. Over 50% of adverse pregnancy outcomes in the UK could be prevented with better care during childbirth (intrapartum care). These failings have significant impact on both families and the NHS. Training for emergencies during childbirth has been recommended almost annually since 1999. A local, multi-professional and inexpensive intrapartum emergencies training course was developed in Bristol, where its implementation was associated with sustained local improvements in a number of clinically important outcomes. The aim of this study is to determine if a multi-professional training programme for local maternity staff (PROMPT) is clinically effective across a health service.
Who can participate?
The study population consists of the 15 Scottish maternity units with more than 1000 births per year
What does the study involve?
The study is a training programme for intrapartum emergencies. It provides the tools for designated in-house trainers to give multi-professional training for intrapartum emergencies for all maternity workers in their own units. Participating units will identify four multi-professional in-house trainers (two midwives, one obstetrician and one anaesthetist) to attend the two-day PROMPT Train-the-Trainers (T3), which comprises a demonstration PROMPT Course and a Train-the-Trainers (T3) day (lectures and workshops for electronic monitoring of the unborn baby and simulated emergency scenarios) to guide in-house trainers in how to set up training in their local unit. Telephone and email support is also provided by the PROMPT team to each participating unit after attending their T3 training. After participating in the two-day PROMPT T3 programme, in-house trainers will be given time to set up and start the in-house PROMPT courses locally. They should aim to have trained all maternity staff in their unit within a year of starting training.
What are the possible benefits and risks of participating?
This intervention programme can improve compliance with clinical standards and lead to a reduction in clinical error. The researchers do not believe there are any disadvantages or risks to participating in this study.
Where is the study run from?
University of Aberdeen in collaboration with PROMPT Maternity Foundation, Bristol (UK)
When is study starting and how long is it expected to run for?
Recruitment will start in late 2013 and the funding will end in late 2016
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
The co-ordinating trial office - Centre for Healthcare Randomised Trials
chart@abdn.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Siladitya Bhattacharya
ORCID ID
Contact details
Institute of Applied Health Sciences
School of Medicine and Dentistry
University of Aberdeen
Aberdeen Maternity Hospital
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
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s.bhattacharya@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CZH/4/893
Study information
Scientific title
Trial of Hands-on Interprofessional Simulation Training for Local Emergencies: a stepped-wedge clustered randomised controlled trial
Acronym
THISTLE
Study hypothesis
Does the implementation of an intrapartum emergencies training package across a health service reduce the rate of Apgar <7 at 5 minutes, in term babies (excluding elective caesarean births)?
Ethics approval
Ethics approval to be applied for 01/08/2013 via proprotionate review with North of Scotland Research Ethics Committee (NoSRES)
Study design
Stepped-wedge clustered randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Perinatal outcomes
Intervention
The intervention is the 2 day PROMPT Train the Trainers (T3) programme; including a demonstration PROMPT course, a Train-The-Trainers (T3) day and local use of the PROMPT Course-in-a-box (Second edition). Four multi-professional in-house trainers from each unit will undertake the 2 day PROMPT T3 programme and then run in-house PROMPT courses locally for all maternity staff in their unit.
The 2 day PROMPT T3 programme will be performed in collaboration with Scottish Core Obstetric Teaching and Training in Emergencies (SCOTTIE).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Proportion of infants born with a low Apgar score (score < 7 vs. ≥7) at 5 minutes for each vaginal or emergency CS term birth (≥37weeks).
Secondary outcome measures
1. Descriptive data from the units will be collated:
1.1. Total number of births per annum
1.2. Total number of staff in the unit separated into staff groups
1.3. Total number of staff trained separated into staff groups
2. Process measures: % of staff trained and time to train local staff.
Overall trial start date
01/08/2013
Overall trial end date
12/09/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The study population will consist of the 15 Scottish maternity units with more than 1000 births per year. Participating units which have not previously undertaken PROMPT training (n=12) will be randomised and be part of the main analysis.
The three units which have already undertaken PROMPT training will not be randomised but will be included in complementary analyses. Their inclusion will allow us to assess the intervention effect at country scale, whilst giving us insight into the long-term sustainability of the intervention effect.
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
15 Scottish maternity units
Participant exclusion criteria
Scottish maternity units or midwifery units with less than 1000 births per year are ineligible for recruitment
Recruitment start date
01/08/2013
Recruitment end date
31/08/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Aberdeen
ABERDEEN
AB25 2ZD
United Kingdom
Funders
Funder type
Government
Funder name
Chief Scientist Office - CZH/4/893
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28882116