ISRCTN ISRCTN10609390
DOI https://doi.org/10.1186/ISRCTN10609390
Sponsor University of Birmingham
Funder Midlands Patient Safety Research Collaboration
Submission date
01/04/2026
Registration date
14/04/2026
Last edited
02/04/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
In maternity care, patients are increasingly encouraged to take an active role in decisions about their care. However, decision-making can be challenging due to limited time, large amounts of information, and differences in health literacy. This study aims to explore whether a theatre-based method (forum theatre) can help improve how services are designed to support patient decision-making.

Who can participate?
Adults aged 18 years and over with experience relevant to maternity care, including service users (not currently pregnant), healthcare professionals, and service managers.

What does the study involve?
Participants will take part in a group session where they will work together to design a maternity care service. Some groups will first watch and interact with a theatre-based scenario showing a patient–clinician consultation, while others will not. All groups will then complete a co-production task. Discussions will be recorded and analysed.

What are the possible benefits and risks of participating?
Participants may benefit from contributing to improvements in maternity care and gaining insight into decision-making processes. Risks are minimal but may include mild emotional discomfort when discussing personal or sensitive experiences. Participants can withdraw at any time.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
March 2026 to December 2026

Who is funding the study?
NIHR Patient Safety Research Collaboration (UK)

Who is the main contact?
Dr Saba Tariq, s.tariq@bham.ac.uk

Contact information

Dr Saba Tariq
Public, Scientific, Principal investigator

Office No. 114, First Floor, Murray Learning Centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom

ORCiD logoORCID ID 0000-0002-6191-0601
Phone +44 (0)7459525748
Email s.tariq@bham.ac.uk

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlActive
AssignmentParallel
PurposeHealth services research
Scientific titleUse of forum theatre in service design and patient decision aids
Study objectives
Ethics approval(s)

Approved 17/02/2026, University of Birmingham Research Ethics Committee (UREC) (University of Birmingham, Edgbaston, Birmingham, B15 2TT, United Kingdom; +44 (0)121 414 3344; aer-ethics@contacts.bham.ac.uk), ref: ERN_4741-Feb2026

Health condition(s) or problem(s) studiedDecision-making in maternity care, specifically informed choice for birth planning (e.g. large-for-gestational-age pregnancies), and optimisation of healthcare service design using forum theatre
InterventionThis study evaluates a forum theatre informed co-production approach for designing maternity services that support patient decision-making compared with standard co-production without theatre input.

The intervention is delivered in two phases.
Phase I: Development of the intervention

A structured decision support tool will be developed in line with International Patient Decision Aid Standards, presenting evidence-based information using layered communication (core and detailed information) and visual formats such as infographics. The tool will focus on a clinically relevant scenario (e.g., induction of labour versus expectant management in suspected large-for-gestational-age pregnancies).

A forum theatre script will be created to simulate a realistic maternity consultation. The script will incorporate key challenges in clinical decision-making, including time constraints, variation in health literacy, and risk of information overload.

Professional actors will perform the scenario using forum theatre techniques. The enactment will allow participants to pause, reflect, and suggest alternative approaches to communication and decision-making. The session will be video-recorded and segmented into key consultation phases (e.g., introduction, risk communication, decision discussion) to support structured engagement.

Phase II: Pilot evaluation using a cluster randomised design

A total of 64 participants will be recruited, including maternity service users, clinicians, and service managers. Participants will be stratified by role and randomly allocated into clusters of eight individuals, ensuring balanced representation across groups.

Participants will be stratified by role (service users, clinicians, and service managers) to ensure balanced representation across groups. Following stratification, participants will be allocated into clusters of eight individuals. Cluster allocation to intervention and control arms will be performed by an independent third party using a computer-generated randomisation sequence, ensuring allocation concealment. Participants will remain blinded to group allocation.

Clusters will be randomised (1:1) into:
1. Intervention group: Participants will view and interact with the forum theatre enactment before undertaking the co-production task.
2. Control group: Participants will proceed directly to the co-production task without exposure to theatre.

All participants will receive a standardised orientation session outlining key decision-making challenges.

Co-production task
Participants will work in mixed stakeholder groups (service users, clinicians, and managers) to design a service model that supports patient decision-making in maternity care. Groups will be provided with flipcharts and asked to produce a structured service specification (e.g., pathway, flowchart, or framework).

Each group will nominate a chairperson responsible for summarising the proposed service model.

Sessions will be audio and video recorded.

Data collection and analysis

Three types of data will be collected:
1. Service design outputs produced by each group
2. Transcripts of group discussions from recorded sessions
3. Participant feedback using structured questionnaires

Analysis will include both qualitative and quantitative approaches:
1. Thematic analysis of discussions to assess depth, diversity, and nature of decision-making considerations
2. Comparison of number and type of themes generated between intervention and control groups
3. Evaluation of service design quality, including inclusion of key elements such as accessibility, clinician support, and information delivery strategies
4. Automated text analysis (e.g., topic modelling) to assess thematic breadth and argument structure
5. Quantitative comparison of participant experience using Likert-scale feedback
Intervention typeBehavioural
Primary outcome measure(s)
  1. Thematic breadth and diversity of co-production discussions, measured using qualitative thematic analysis and automated text analysis (including topic modelling techniques such as Latent Dirichlet Allocation), at immediately following the co-production sessions based on recorded and transcribed discussions
Key secondary outcome measure(s)

1. Quality of service design outputs, measured using structured evaluation criteria (including number of components and inclusion of key service elements), assessed within 3 to 6 months following the workshop sessions, after transcription and thematic analysis of recorded data
2. Participant experience and perceived usefulness of the process, measured using a structured post-session questionnaire with Likert-scale responses, collected immediately after participation
3. Argumentative structure and thematic variation in discussions, measured using automated text analysis (e.g., topic modelling, argument sophistication indices), conducted after transcription of recorded sessions

Completion date30/12/2026

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit85 Years
SexAll
Target sample size at registration64
Key inclusion criteriaAdults aged ≥18 years able to provide informed consent. Participants will include:
1. Maternity service users with previous experience of maternity care (not currently pregnant)
2. Clinicians (e.g. midwives, doctors, or other healthcare professionals with maternity experience)
3. Service managers or stakeholders involved in maternity service design
Participants must be able to engage in group discussion in English
Key exclusion criteria1. Individuals unable to provide informed consent
2. Individuals currently pregnant
3. Individuals experiencing distress or vulnerability that would make participation inappropriate
4. Those unable to participate in group discussions
Date of first enrolment13/03/2026
Date of final enrolment01/07/2026

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of Birmingham
Edgbaston
Birmingham
B15 2TT
England

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

01/04/2026: Study's existence confirmed by the University of Birmingham Research Ethics Committee (UREC).