Abstract
Background
The 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/design
The 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.
Discussion
Community 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 registration
ISRCTN registry: registration number 63066975. Registered on 18 August 2015.
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Details
1 University College London, Social Science Research Unit (SSRU), UCL Institute of Education, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201)
2 University House, UH250, Stratford Campus, University of East London, Institute for Health and Human Development, London, UK (GRID:grid.60969.30) (ISNI:0000 0001 2189 1306)
3 Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK (GRID:grid.4868.2) (ISNI:0000 0001 2171 1133)
4 University College London, Royal Free Medical School, Department of Primary Care and Population Health, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201)
5 Royal London Hospital, Barts Health NHS Trust, London, UK (GRID:grid.416041.6) (ISNI:0000 0001 0738 5466)
6 City University of London, School of Health Sciences, London, UK (GRID:grid.28577.3f) (ISNI:0000 0004 1936 8497)
7 Newham University Hospital, Barts Health NHS Trust, London, UK (GRID:grid.439313.f)
8 University College London, Social Science Research Unit (SSRU), UCL Institute of Education, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201); Lay Minister, London, UK (GRID:grid.83440.3b)
9 Elizabeth Garrett Anderson Wing, University College London Hospitals NHS Foundation Trust, London, UK (GRID:grid.52996.31) (ISNI:0000 0000 8937 2257)
10 The Princess Alexandra Hospital NHS Trust, Essex, UK (GRID:grid.437503.6) (ISNI:0000 0000 9219 2564)
11 Homerton University Hospital NHS Foundation Trust, London, UK (GRID:grid.448742.9)
12 North Middlesex University Hospital NHS Trust, London, UK (GRID:grid.439355.d)
13 Whittington Health NHS Trust, London, UK (GRID:grid.417095.e) (ISNI:0000 0004 4687 3624)