Condition category
Pregnancy and Childbirth
Date applied
02/03/2020
Date assigned
06/04/2020
Last edited
12/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Informed discussion between community midwives and healthy low risk women about their options for giving birth is important in helping parents decide where to give birth. There is evidence to suggest that this discussion does not always take place. A previous study suggested that a knowledge update session together with ongoing support from a Place of Birth lead midwife in each team improved the knowledge and confidence of community midwives. Four maternity units (Royal Wolverhampton NHS Trust, Walsall Healthcare NHS Trust, Dudley Group NHS Foundation Trust, and Sandwell and West Birmingham Hospitals NHS Trust) that make up the Black Country Local Maternity System (LMS) decided to make completing an e-learning session mandatory for all their community midwives. The Black Country LMS Heads of Midwifery were keen to test whether having a place of birth lead midwife further improves fact based knowledge. The aim therefore of the BEEM study is to evaluate whether a Place of Birth lead in community midwifery teams further improves the fact based knowledge of community midwives compared to completing the e-learning session alone. To do this we are undertaking a cluster controlled randomised trial, which takes account of the issue that using a questionnaire in itself before and after training is likely to improve knowledge.

Who can participate?
All community midwives (Band 5, 6 and 7) working in a specified Local Maternity System.

What does the study involve?
Each community midwifery team in the Black Country LMS will be randomly allocated to one of four possible options:
1. Doing the e-learning package and a post-questionnaire to examine fact-based knowledge and confidence of community midwives six months later
2. Doing a pre-questionnaire to examine fact-based knowledge and confidence of community midwives before doing the e-learning package and then another questionnaire six months later
3. Having the Place of Birth lead midwife in the team who will support and encourage the midwives as well as doing the e-learning package and post-questionnaire six months later
4. Having a Place of Birth midwife in the team who will support and encourage the midwives as well as doing a pre-questionnaire to examine the fact-based knowledge and confidence of community midwives before they do the e-learning package and then a post-questionnaire six months afterwards

For those teams randomised to having a Place of Birth team lead will appoint a community midwife from the team who will complete an additional e-learning package to train for the role. They will then be responsible for encouraging midwives in their team to complete the e-learning session and questionnaire(s) as well as support and encourage colleagues to talk to women about their place of birth options. They will use provided materials to facilitate six monthly sessions (10 to 20 minutes each) usually as part of the routine team meeting and remind of the importance of the Place of Birth discussions as well as act as an expert for any queries the midwives have.

For the community teams not randomly allocated to having a place of birth lead, the community midwife team lead will encourage team members to complete the elearning package and relevant questionnaire(s). They will not complete any additional follow up sessions.

Following completion of the study, two focus groups will be conducted in each Trust in order to explore the experiences and practices of community midwives in connection with Place of Birth discussions: one for those who have had a Place of Birth lead and one for those who have not. In addition, a further focus group from across the LMS will be conducted for the Place of Birth leads. Each focus group session will be recorded and conducted by a member of the research team, last approximately 30 to 60 minutes and will have a mixture of closed and open questions.

What are the possible benefits and risks of participating?
The potential benefits are improved knowledge and confidence to discuss place of birth options with mothers. There are no risks to taking part in the study.

Where is the study run from?
1. New Cross Hospital (UK)
2. Manor Hospital (UK)
3. Russells Hall Hospital (UK)
4. Birmingham City Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2020 to May 2021

Who is funding the study?
NIHR Applied Research Collaboration (ARC) West Midlands (UK)

Who is the main contact?
Prof. Sara Kenyon (scientific)
s.kenyon@bham.ac.uk
Fiona Cross-Sudworth (public)
f.cross-sudworth@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sara Kenyon

ORCID ID

Contact details

University of Birmingham
Institute of Applied Healthcare
Murray Learning Centre
Birmingham
B15 2TT
United Kingdom
+44 (0)121414 9063
s.kenyon@bham.ac.uk

Type

Public

Additional contact

Ms Fiona Cross-Sudworth

ORCID ID

http://orcid.org/0000-0002-5223-1789

Contact details

University of Birmingham
Institute of Applied Healthcare
Murray Learning Centre
Birmingham
B15 2TT
United Kingdom
+44 (0)1214158182
f.cross-sudworth@bham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Protocol V 2.0 14.01.2020, IRAS 272343

Study information

Scientific title

Place of Birth choices for healthy low-risk women: A comparison of a standalone E-Learning package or an e-learning package with additional support from a lead midwife to Evaluate the knowledge of community Midwives- a randomised cluster controlled trial incorporating a modified solomon design: The BEEM trial

Acronym

BEEM

Study hypothesis

The objective of this research is to evaluate whether a Place of Birth lead midwife in addition to a mandated e-learning session further improves the fact based knowledge of community midwives.

Ethics approval

1. Approved 04/11/2019, University of Birmingham REC (Sue Cottam – Research Ethics Manager Aston Webb Building, University of Birmingham, Edgbaston B15 2TT, UK; +44 (0)121 414 8825; s.l.cottam@bham.ac.uk), ref: ERN_19-1382
2. Approved 16/01/2020, HRA and Health and Care Research Wales (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; no tel. provided; hra.approval@nhs.net), ref: ERN_19-1382

Study design

Randomized cluster controlled trial incorporating a modified Solomon design with qualitative follow-up

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Knowledge of community midwives

Intervention

The intervention is the Place of Birth Lead.

The unit of randomisation will be the community midwifery team within each of the four participating NHS Trusts, stratifying within each to ensure that each Trust has the opportunity to have a Place of Birth lead midwife within a randomised number of teams, as these vary in number and size. Individual randomisation of community midwives to the Place of Birth lead was not feasible due to the nature of the intervention (Place of Birth lead) and risk of contamination during the trial.

To measure the knowledge of the community midwives we will use the same short fact-based questionnaires completed over the three-week period immediately before the e-learning session is undertaken and again six months later. These have been developed by the study team and include key facts which midwives should be aware of in order to speak to healthy low risk women about their place of birth options. The Solomon design has been modified as all teams will complete the e-learning training session.

Each community midwifery team will be randomly allocated to one of four possible arms:
1. Doing the e-learning package and a post-questionnaire to examine fact-based knowledge and confidence of community midwives six months later
2. Doing a pre-questionnaire to examine fact-based knowledge and confidence of community midwives before doing the e-learning package and then another questionnaire six months later
3. Having the Place of Birth lead midwife in the team who will support and encourage the midwives as well as doing the e-learning package and post-questionnaire six months later
4. Having a Place of Birth midwife in the team who will support and encourage the midwives as well as doing a pre-questionnaire to examine the fact-based knowledge and confidence of community midwives before they do the e-learning package and then a post-questionnaire six months afterwards

Qualitative follow-up:

Intervention type

Other

Phase

Drug names

Primary outcome measure

Fact based knowledge of community midwives measured using anonymous completion of a fact-based knowledge questionnaire in a three-week period before the e-Learning session is undertaken and again six months afterwards

Secondary outcome measures

1. Knowledge improvement with E-Learning session alone by anonymous completion of a fact-based knowledge questionnaire in a three-week period before the e-Learning session is undertaken and again six months afterwards
2. Self-rated confidence of community midwives by anonymous completion of a 5 point Likert scale in a three-week period before the e-Learning session is undertaken and again six months afterwards
3. Experiences of community midwives whose teams are randomised to a Place of Birth lead midwife and those who are not by qualitative data obtained from focus groups with community midwives whose teams had a Place of Birth lead and those who are not. Focus groups will be undertaken after the six-month intervention period
4. Experiences of the Place of Birth lead midwives using qualitative data obtained from focus groups with Place of Birth leads undertaken after the 6 month intervention period
5. Responses to the ‘Safety thermometer’ question ‘Did anyone explain your options for where you could give birth?’ This is a set of questions that are routinely given to a sample of women and which will continue over the six-month intervention period. This information is recorded monthly by the Trust and data will be given to UoB after the six month intervention period

Overall trial start date

01/02/2020

Overall trial end date

31/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All community midwives (Band 5, 6 and 7) working in a specified LMS

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

There are approximately 185 community midwives in the LMS

Participant exclusion criteria

1. Community midwives who are Band 8 and above
2. Student midwives

Recruitment start date

01/07/2020

Recruitment end date

28/02/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

New Cross Hospital
Royal Wolverhampton NHS Trust Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Manor Hospital
Walsall Healthcare NHS Trust Moat Road
Walsall
WS2 9PS
United Kingdom

Trial participating centre

Russells Hall Hospital
Dudley Group NHS Foundation Trust Pensnett Road
Dudley
DY1 2HQ
United Kingdom

Trial participating centre

Birmingham City Hospital
Sandwell & West Birmingham Hospital NHS Trust Dudley Road
Birmingham
B18 7QH
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 8037
researchgovernance@contacts.bham.ac.uk

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/index.aspx

Funders

Funder type

Government

Funder name

NIHR Applied Research Collaboration (ARC) West Midlands

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The research team will share the outcomes of the evaluation process with the Place of Birth leads and key stakeholders of each Trust. This will describe how the Place of Birth package has been effective with or without the implementation of a Place of Birth lead and any feedback from the Place of Birth leads and Community Midwives will be documented.

Following this, the research team will produce a summary report for the Trusts that will detail the outcomes of the evaluation (effectiveness of the Place of Birth leads for knowledge improvements, feedback from focus groups and safety thermometer question outcomes)- what worked and did not, and any revisions required. A number of reports and publications are anticipated to be produced. Participants will be able to access these publications via the Trust website, or through contacting a member of the research team.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to limited interest.

Intention to publish date

31/05/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/05/2020: Due to current public health guidance, recruitment for this study has been paused. 03/03/2020: Trial’s existence confirmed by NHS HRA.