Trial of Hands-on Interprofessional Simulation Training for Local Emergencies
| ISRCTN | ISRCTN11640515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11640515 |
| IRAS number | 134679 |
| Secondary identifying numbers | CZH/4/893, IRAS 134679 |
- Submission date
- 30/07/2013
- Registration date
- 09/09/2013
- Last edited
- 25/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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 errors. 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 the study starting and how long is it expected to run for?
August 2023 to December 2024
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
Contact information
Scientific
Institute of Applied Health Sciences
School of Medicine and Dentistry
University of Aberdeen
Aberdeen Maternity Hospital
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| s.bhattacharya@abdn.ac.uk |
Study information
| Study design | Stepped-wedge clustered randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Trial of Hands-on Interprofessional Simulation Training for Local Emergencies: a stepped-wedge clustered randomised controlled trial |
| Study acronym | THISTLE |
| Study objectives | 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(s) |
Approved 13/08/2013, North of Scotland, Committee 1 (Summerfield House, Aberdeen, AB15 6RE, United Kingdom; +44 (0)1224 558458; gram.nosres@nhs.scot), ref: 13/NS/0111 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2013 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 Scottish maternity units |
| Total final enrolment | 15 |
| Key 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. |
| Key exclusion criteria | Scottish maternity units or midwifery units with less than 1000 births per year are ineligible for recruitment |
| Date of first enrolment | 01/08/2013 |
| Date of final enrolment | 31/08/2016 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
AB25 2ZD
United Kingdom
Sponsor information
University/education
Research and Innovation
Kings College
Regent Walk
Aberdeen
AB24 3FX
Scotland
United Kingdom
"ROR" |
https://ror.org/016476m91 |
|---|
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/09/2017 | Yes | No | |
| Results article | 13/07/2019 | 19/06/2024 | Yes | No |
Editorial Notes
25/06/2024: The overall study end date was changed from 31/08/2022 to 31/12/2024.
19/06/2024: The following changes have been made:
1. Publication reference added.
2. IRAS number added.
3. Ethics approval added.
4. The intention to publish date was changed from 31/12/2023 to 30/06/2025.
04/01/2023: The Intention to publish date has been changed from 31/12/2022 to 31/12/2023.
08/08/2022: The total final enrolment was added.
05/08/2022: The intention to publish date was added.
13/07/2020: The overall end date was changed from 12/09/2017 to 31/08/2022.
19/10/2017: Publication reference added.
04/08/2017: The overall trial end date has been updated from 31/08/2016 to 12/09/2017.
