Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations

Abstract

BackgroundThe provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue.Methods/designThe study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2–7 and 8–13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority.DiscussionCommunity REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and delivered by local communities. This pragmatic cluster randomised controlled trial, with integrated process and economic evaluation, aims to rigorously assess the effectiveness of this public health intervention, which is particularly complex due to the required combination of standardisation with local flexibility. It will also answer questions about scalability and generalisability.Trial registrationISRCTN registry: registration number 63066975. Registered on 18 August 2015.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2526-6) contains supplementary material, which is available to authorized users.

Facilitators and barriers to seeking and engaging with antenatal care in high‐income countries: A meta‐synthesis of qualitative research

“…For example, Satwell et al have designed an intervention to overcome some of the barriers identified in this study, including lack of health literacy, by co‐producing an intervention with the involvement of their community to reduce the high rates of late initiation of antenatal care in the UK. The intervention is co‐produced and locally tailored to each participating site (Sawtell et al, 2018 ).…”

Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial—data management experience from the DESiGN Trial team

“…Whilst there are many examples of national epidemiological research and audit conducted using EPR data over the past 20 years [ 2 ], clinical trials using data collected from EPR have only become more prevalent in the last 5 years. Examples in maternal and perinatal medicine come from Canada [ 3 ], Sweden [ 4 ], the Netherlands [ 5 ], Scotland [ 6 , 7 ], Wales [ 8 ] and England [ 9 , 10 ].…”

Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

“…While academic-practitioner collaboration in the conduct of RCTs is increasingly common, it remains relatively unusual for allied health professionals, including midwives, to be at the centre of such research. In this study, as with others in the REACH programme [44], the aim will be to have midwives as key collaborators at both central research and site team level (for example as site Principal Investigators). This will not only help to maximise the rigour, relevance and success of the work but also build research capacity in the midwifery profession and NHS trust maternity research teams.…”