The Core Study - Exploring the implementation of maternity and neonatal multi-professional training in England

ISRCTN ISRCTN17083933
DOI https://doi.org/10.1186/ISRCTN17083933
IRAS number 337557
Secondary identifying numbers NIHR159486
Submission date
08/11/2024
Registration date
12/11/2024
Last edited
02/07/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This project seeks to evaluate an NHS England initiative to improve the organisation and delivery of staff training in maternity and neonatal services. There is widespread concern about the quality and safety of maternity and neonatal services in England. There are worrying inequalities in outcomes. Reports repeatedly indicate the crucial role of skilful and knowledgeable staff, working well together. Yet it is known that training is not always prioritised within busy maternity and neonatal services and that there is variability in such training. To address this, NHS England launched a ‘Core Competency Framework’ (December 2020) to support the organisation of effective training for all maternity and neonatal staff. The Framework includes suggested training modules. The second version of the Framework (December 2023) built on this, with a training needs analysis tool that calculates the number of days of training each staff group should receive and a ‘how to’ guide. It also highlighted key ‘best practice’ principles: service user involvement; learning from local feedback/incidents/good practice; multidisciplinary team learning; and shared learning across Local Maternity and Neonatal Systems. The Framework is intended to drive improvement in maternity and neonatal care, but its impact is currently not known. Although some basic measures are now monitored (e.g. number of staff attending training), there is no built-in evaluation. This means there is no national-level insight into how the Framework is delivered, and its impact on organisational, team and individual skills and knowledge. Nor its impact on the quality of care and outcomes, particularly for those most at risk of poor outcomes. This project aims to fill that gap by exploring the implementation, operation and impact of the Framework. There is widespread support for this study amongst service user representatives. An advisory group, local service user panels and local and national Forums built into our evaluation design will create spaces in which service user questions and concerns can be heard. Stakeholder perspectives will be gathered through three linked pieces of work (Work Packages (WP)).

Who can participate?
The study will invite staff from across all 121 maternity and neonatal units in England, who take a lead on the CCF in their NHS Trust to complete an online survey about the way the CCF is implemented in their organisation. Part of this study will be based in six NHS Trusts across England that will remain anonymous. Maternity or neonatal staff, and service users representatives, who are responsible for the planning or delivery of the CCF, from the NHS Trusts, will participate in interviews, observations, and a meeting to learn about, and feedback on, their local data. Service users who gave birth at each of the six NHS Trusts to take part in small group discussions or interviews will also be invited.

What does the study involve?
A national survey will be conducted to gather views about the Framework's implementation across England’s maternity and neonatal units. The study will undertake ethnographic research to explore in detail implementation at six selected sites; this will also include local service user focus groups drawn from groups most at risk of poor outcomes. Joint interpretive forums will be held at the local and national level, which will help to make sense of the data and feed into the development of a logic model and implementation toolkit for NHS England, to support the next version of the CCF (December 2026). A short animation will be created offering service user perspectives on maternity and neonatal staff training, to increase NHS engagement with this initiative. The project team has worked with NHS England, and their service user group, on the study design; NHS England supports our planned evaluation. Findings and an implementation toolkit will be shared at regional and national conferences and publish at least two high-impact academic papers.

What are the possible benefits and risks of participating?
There are no direct benefits to those participating, but it is hoped their input will help improve multi-professional maternity and neonatal training in future. Reflecting on issues relating to maternity and neonatal care can sometimes prove challenging for women and members of staff alike. In group discussions or interviews, the team researchers, who are experienced in handling conversations of a sensitive nature, will ensure that participants have opportunities to pause, stop, re-schedule, or withdraw from the group discussion or interview. Systems are in place to ensure participants receive confidential support.

Where is the study run from?
The study is run by researchers based at King's College London and will be conducted across six NHS Trusts in England.

When is the study starting and how long is it expected to run for?
The study started in September 2024 and will run until June 2026

Who is funding the main study?
The study is a Health and Social Care Delivery Research Programme funded by the National Institute for Health and Care Research.

Who is the main contact?
Dr Rebecca Whybrow, rebecca.whybrow@kcl.ac.uk

Study website

Contact information

Dr Rebecca Whybrow
Public, Scientific, Principal Investigator

King's College London
James Clark Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom

Phone +44 (0)2078482792
Email rebecca.whybrow@kcl.ac.uk

Study information

Study designMulti-site mixed methods observational study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleImproving maternity and neonatal care in England: a formative evaluation of the implementation of the Core Competency Framework to improve multi-professional practice
Study acronymThe Core Study
Study objectivesTo explore and enhance the implementation and impact of the Core Competency Framework (CCF) in England as it seeks to reduce variation in maternity and neonatal care.
Ethics approval(s)Approved 06/02/2025, HRA North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8290; gmeast.rec@hra.nhs.uk), ref: 24/NW/0384
Health condition(s) or problem(s) studiedMulti-professional maternity and neonatal training
InterventionA mixed-methods national online survey will be distributed on two occasions (around one year apart) among all maternity and neonatal units in England.

An ethnographic study will be conducted in six NHS Trusts in England, comprising (1) interviews with NHS staff and service user representatives involved in the planning and delivery of the Core Competency Framework (CCF), (2) non-participant observations of staff interactions relating to training, the collection of training-related documentary evidence from each participating NHS Trust, (3) group discussions or interviews with local service users, and (4) a local joint interpretive forum meeting that is offered to each participating NHS Trust at which local data is presented and the opportunity given to reflect on this data. An animation representing data from service user interviews will be developed.

Finally, a national joint interpretative forum meeting will be held to present synthesised study findings and explore how best to align a future version of the CCF with national policies and strategies relating to improving CCF implementation and maternity care provision.
Intervention typeOther
Primary outcome measureThis is an observational study based predominantly on qualitative data to evaluate the implementation of the Core Competency Framework (CCF). Implementation will be assessed in the following ways:
1. The adoption, adaption and implementation across time, of the CCF in maternity and neonatal units in England is measured using a survey based on the TIDIER checklist and a NoMAD survey at baseline and one year
2. Staff attitudes and opinions about the CCF among the Multi-professional Education Training (MET) team and senior maternity and neonatal leaders, and its implementation in their organisation are measured using semi-structured interviews at various undefined timepoints from baseline to one year
3. Ethnographic observations of the implementation of staff training and associated training-related activities at various undefined timepoints from baseline to one year
4. Service users’ perceptions and experiences of competent maternity and neonatal care that they trust and in which they have confidence are measured using semi-structured interviews at various undefined timepoints from baseline to month seven
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/09/2024
Completion date30/06/2026

Eligibility

Participant type(s)Health professional, Service user
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants61
Key inclusion criteria1. Maternity and neonatal unit organisational lead for the Core Competency Framework (CCF) v2

Participation in semi-structured interviews:
1. Take a lead role in, or support the delivery of multi-professional safety and training at one of the participating NHS Trusts
2. Are the local MNVP chair or other service users involved in training, governance lead head of service, or the local LMNS representative involved in supporting delivery of the CCF, and give consent to be interviewed

Participation in local joint interpretive forums:
1. Staff members from each of the six study sites in the MET team, senior maternity and neonatal managers, LMNS and MNVP representatives and others with a lead role in training and quality improvement

Service users:
1. Aged 18 years old and over
2. Gave birth in the past year in one of the six participating NHS Hospital Trusts
3. Willing to participate and give consent to do so
Key exclusion criteriaDoes not meet the pParticipant inclusion criteria
Date of first enrolment01/06/2025
Date of final enrolment30/06/2026

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King's College London - Administrative site
James Clark Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom

Sponsor information

King's College London
University/education

Room 8.11, 8th Floor Melbourne House, 44-46 Aldwych
London
WC2B 4LL
England
United Kingdom

Phone +44 (0)207 848 7306
Email vpri@kcl.ac.uk
Website https://www.kcl.ac.uk/
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date30/04/2027
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned publication in several high-impact peer-reviewed journals.
IPD sharing planThe datasets generated and analysed during the current study will be stored in a publicly available repository (King’s Open Research Data System https://kcl.figshare.com/) for 10 years after the end of the study. The datasets will be fully anonymised and consent will have been gained from participants for thei data to be made available in this way.

Editorial Notes

02/07/2025: The following changes were made to the study record:
1. The date of first enrolment was changed from 01/01/2025 to 01/06/2025.
2. The date of final enrolment and completion date were changed from 30/04/2026 to 30/06/2026.
3. Ethics approval details added.
11/11/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).