Discussion
inner-city, PTB
This study reports the results of a mixed methods evaluation alongside a hybrid type 2 pilot RCT. The introduction of a model of midwifery continuity of care linked with specialist obstetric care for women at increased risk of PTB (POPPIE) was found to be appropriate to address local needs in a UK inner-city maternity service despite challenges in early adoption (e.g. lack of similar models, service reconfiguration). Collaborative working and availability of additional funding certainly facilitated adoption efforts. We demonstrated it is feasible to set up and maintain appropriate levels of fidelity of the POPPIE model with overall good acceptability among women and HCPs in both our quantitative and qualitative analysis. The model was eventually embedded within established maternity services and, after the trial, it was sustained and adapted to provide care to a mixed risk caseload of women with further scale up of other continuity models. Process outcomes were also similar in both models of care. Overall, we found no association between specific implementation and process measures and the primary outcome.Implementation fidelity, thought to be critical to successful translation of evidence-based interventions into practice [Despite multiple strategies adopted, the embedment of the model within existing services required longer than expected, and collaboration and good communication among HCPs were crucial to address issues in relation to how the POPPIE team worked. Although this was not very surprising; until recently, there was very little guideline on implementation and scale-up of continuity models, and the introduction of a first continuity model in our context, involved a complex, large-scale transformation of the organisation of maternity services requiring whole system support and close alignment between top and frontline leadership [This is one of the few studies in maternity care (and the first of a midwifery continuity of care model) that rigorously uses implementation frameworks and mixed methods research to examine multiple process measures and analyse them alongside the primary outcome [Although high quality implementation has previously been associated with better outcomes on individual level in health promotion programmes, it may not be the case for organisational-level implementation measured in a multidisciplinary healthcare context [Nearly a third of women in the pilot study were from ethnic minority groups, more than two thirds lived in areas of social deprivation and more than a quarter had at least one pre-existing medical condition and multiple obstetric risk factors for PTB [It is also possible that community-based models of care that focus on local people and communities and enhance place-based level of health and social care services can have a different impact on clinical and processes outcomes and inequalities when compared to hospital-based care models like POPPIE [