Title: IMPART IMplementation of the Preterm Birth Surveillance PAthway: a RealisT evaluation (including a realist literature scope)
Funder: Health Education England

Abstract: Background: In the UK 8% babies are born preterm (before 37 weeks' gestation), which is associated with high mortality and morbidity. Currently some women at risk of preterm birth are referred to a specialist Preterm Birth Prevention Clinic alongside standard care, while the majority are offered standard care only. Only 33 consultant-led hospitals have a specialist preterm clinic out of 187 hospitals offering UK obstetric care (Care et al., 2018). Guidance recommends a new 'Preterm Birth Surveillance Pathway' (NHS England, 2019a) to standardise care and to reduce the preterm birth rate. This involves midwives assessing all women for their risk of preterm birth. Women at high or intermediate risk should be referred to a Preterm Birth Prevention Clinic alongside normal care, where they can be offered further screening tests and interventions. This pathway is in the NHS standard contract, meaning maternity providers should implement this by April 2020 (NHS England, 2019b). This study aims to research how, why, for whom, to what extent and in what contexts the Preterm Birth Surveillance Pathway is implemented through a realist evaluation (including a realist literature scope). Research question: To understand how, why, for whom, to what extent and in what contexts the Preterm Birth Surveillance Pathway is successfully (and unsuccessfully) implemented Aims and objectives Objectives: To identify contexts and mechanisms leading to both positive and negative outcomes in terms of implementation of the PBP. To understand the relationship between the contexts, mechanisms and outcomes in implementing the PBP. To identify and assess a range of implementation outcomes in implementing the PBP, and any unintended consequences. To determine optimal implementation theories for effective national uptake of PBP, to produce a set of recommendations to implement the pathway in a range of hospitals.Secondary Clinical objective: Determine whether implementation of the Pathway will reduce the incidence of women having a singleton pregnancy having a preterm birth (liveborn and stillborn) as a % of all singleton births: a. from 16+0 - 23+6 weeks' gestationb. from 24+0 - 36+6 weeks' gestation Methods: Realist evaluators are aware that pathways may have different effects for different units (Westhorp et al., 2011). Instead of just asking 'what works?', realist evaluation asks 'what works, for whom, in what circumstances?' (Pawson and Tilley, 1997). The mixed methods data collection includes: women and staff interviews, observing staff, analysing hospital documentation, and analysing routinely collected hospital and administrative data across three demographically different case sites situated in different Local Maternity Systems. Impact: This research will ensure the PBP is implemented effectively. This will help reduce preterm birth from 8% to 6% by 2025 (Department of Health, 2017), and reduce the annual NHS preterm birth cost of over one billion pounds (Mangham et al., 2009). Dissemination: A plan will be created with PPI input to include publications, conferences, a webinar, clinical networks, mailing lists, media, parent and baby/antenatal groups.

Lay abstract: In the UK, 1 in 13 babies are born early (before a woman reaches 37 weeks of pregnancy) - otherwise known as 'preterm'. This means that around 60,000 babies are born preterm every year. Many preterm babies do not survive. If they do survive, they often have long-term health problems. Because of these poor health outcomes, the Department of Health plans to reduce the preterm birth rate. This would also help the NHS save money as preterm birth currently costs the NHS one billion pounds a year. Currently, women who are at risk of having a preterm birth receive different care depending on which hospital they receive treatment at. Some women are offered specialist care in a preterm birth prevention clinic, but many women do not receive any specialist care. At present, only 33 hospitals have a preterm birth prevention clinic out of 187 hospitals offering maternity care across the UK. NHS England has recently published some guidance on how to reduce preterm birth and help standardise care across the UK. This means that all women will receive the same care, even if they are at different hospitals. The new guidance has developed a pathway called the Preterm Birth Surveillance Pathway (PBP). This pathway says that midwives should assess every pregnant woman for her risk of having a preterm birth. This assessment will involve asking a woman questions about her medical history and deciding whether she is at high, intermediate or low risk of a preterm birth. If the midwife assesses the woman as being at high or intermediate risk of having her baby early, then they should refer her to a special preterm birth prevention clinic. Preterm birth prevention clinics are clinics where specialist doctors and midwives can offer the woman additional tests (such as scans and swab tests) alongside the normal care she receives when she is pregnant. These additional tests can help doctors and midwives decide which women may need further help, such as being admitted to hospital, to help stop her having her baby early. Now that this new guidance has been published, all hospitals are expected to follow the PBP for pregnant women at risk of having their baby early by April 2020. This will be a big change for many hospitals. This is the first-time guidance has recommended a PBP so it has never been reviewed or evaluated before. This study aims to research how, why, for whom, to what extent and in what contexts the Preterm Birth Surveillance Pathway is implemented through a realist evaluation (including a realist literature scope). A realist evaluation is a study design which would consider how the PBP may work differently in different hospitals. Instead of just asking 'what works?', realist evaluation asks 'what works, for whom, in what circumstances?'. The data for the realist evaluation will be collected through mixed methods (interviews with women and staff, observing staff, looking at hospital guidelines and documentation, and analysing routinely collected hospital and admin data). This study will focus on three different hospitals to find out what happens in practice when hospitals start to use the PBP, explore what factors help or do not help implementation, and develop theories on how implementation of the pathway can be improved. This will lead to producing a set of recommendations for implementing the pathway in different hospitals so that it is taken up effectively across England.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH