Work Packages

1. Conceptualisation and scientific support for the development of the complex intervention

This work package has:

• reviewed the evidence to inform selection of MCB elements;
• engaged with key professional and lay stakeholders and identified key system barriers to MCB implementation in a series of workshops;
• analysed an existing dataset and supported the evidence-based development of the national self-assessment questionnaire on venous thromboembolism (VTE) risk;
• developed a theory of change and logic model for the MCB.

2. Establishing the PRiSMM data platform

The aim of this work package is to create a unified, comprehensive, population-based, England-wide dataset (the PRiSMM data platform), with a single point of access within the NHS Research Secure Data Environment (SDE) Network to enable the evaluation of the MCB and subsequent iterations. The new data platform will also improve the national monitoring of maternal morbidity, demonstrating where inequity exists across population groups and locations and provide the data needed to inform safety surveillance.

The single point of access for the PRiSMM data platform will be the Thames Valley & Surrey Secure Data Environment (TVS SDE) which is hosted by Oxford University Hospitals NHS Foundation Trust.

The PRiSMM data platform will require new data flows of individual patient data from NHS Trusts across England to be linked and embedded within the Secure Data Environment (SDE) network. This will need to be a gradual process because the level of digital maturity in NHS Trusts across England varies, and some Trusts will require more time than others to complete the work needed to facilitate the flow of data.

The PRiSMM team will initially work with 8 champion sites during the pilot phase of the study to begin this process and the data flows will include the data that is routinely collected for all women receiving care whose electronic patient record indicates a pregnancy and any babies born as a result of those pregnancies. Data will be automatically included in this PRiSMM data platform.

Sites have been selected to ensure that data flows are established across a variety of clinical settings, from Trusts with different data systems, geographical challenges and patient populations. After this work has been completed and using lessons learned from the pilot phase, the PRiSMM team will start to bring in data from all Trusts in England into the TVS SDE, on-boarding sites in stages until national coverage has been achieved and the complete national dataset which can be updated in (near) real time is fully realised.

Data held within the PRiSMM data platform will be used to provide information on severe maternal morbidity in England and for safety surveillance, for example, tracking how a hospital is performing to help identify patient safety concerns. For this phase of the programme, we are asking for permission to use data for all women and their babies in the dataset to ensure that we can provide accurate information to aid hospitals and policy makers to make informed decisions and act where necessary to improve safety and patient outcomes.

We will also use the PRiSMM dataset for research purposes to allow us to evaluate the introduction of the MCB. As this is research, women may choose to opt out of their data being used in this way by applying to the National Data Opt-Out service or contacting the TVS SDE directly. For more information on our use of personal data and options for opting out please see our 'Use of Personal Data' page.

The NHS Data for R&D Programme has selected PRiSMM as a 'Driver' project to develop within the regional network of SDEs, to demonstrate their potential and feed into the forthcoming Health Data Research Service (HDRS).

3. Analysis of the MCB at 'champion sites'

The aim of this work package will be to evaluate the introduction of the MCB at five of the champion sites already recruited to establish the PRiSMM data platform by assessing: -

• the processes of implementation and adoption;
• the feasibility and acceptability of the intervention to women and the staff asked to implement it;
• the reach and fidelity of the intervention.

At each of the champion sites, the PRiSMM team will work with the local teams to identify pregnant or recently pregnant women and members of staff involved in their care or in the administration and roll-out of the MCB. These individuals will be invited to participate in 1:1 interviews (women) or focus groups (staff).

• 1:1 interviews with women

Researchers will conduct semi-structured interviews with the women guided by topic guides, designed by the research team in advance with input from the PPIE contributors and groups. They will explore views on the MCB as well as barriers to care, accessibility and acceptability to women who are marginalised and those who experience health inequalities. Interviews will take place virtually where possible, but where appropriate face to face interviews will be undertaken.

To facilitate an in-depth understanding of implementation feasibility and acceptability of each of the five elements of the MCB, the team will ensure that the views from women with a range of diverse backgrounds and with a range of exposures to each of the elements of the MCB are consulted.

• Focus groups with staff

Members of staff involved in all aspects of delivering components of the MCB will be invited to participate including clinical staff (midwives, obstetricians, nurses and specialist healthcare professionals including perinatal mental health, ambulance or emergency department staff), as well as administrative and managerial staff.

Focus groups will be run at each of the champion sites to discuss specifically the five elements of the MCB and will be carried out either virtually where possible or face-to-face if appropriate. Topic guides designed in advance by researchers with input from the PPIE contributors and groups will be used. They will explore healthcare professionals' views and experience of organising and/or delivering the MCB, including adoption, barriers and facilitators to implementation and identifying wider consequences of the intervention. Clinical staff will also be asked for their views on which elements of the MCB will require additional staff to implement, either through recruitment of staff or increasing staff commitments.

4. Evaluation of clinical and cost effectiveness of MCB

The aim of this work package will be: -

• to assess the association between receipt of the MCB intervention (and its elements) and adverse outcomes, to quantify clinical effectiveness;
• to establish whether the benefits are equitable across all ethnic and socioeconomic groups;
• to identify unintended consequences related to clinical patient outcomes;
• to assess whether the MCB is cost-effective when compared to no care bundle;
• to assess the implementation of the MCB.