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 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 2â 7 and 8â 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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PID https://www.doi.org/10.6084/m9.figshare.c.4023130
PID https://www.doi.org/10.6084/m9.figshare.c.4023130.v1
URL http://dx.doi.org/10.6084/m9.figshare.c.4023130.v1
URL http://dx.doi.org/10.6084/m9.figshare.c.4023130
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Author Sawtell, Mary
Author Sweeney, Lorna
Author Wiggins, Meg
Author Salisbury, Cathryn
Author Eldridge, Sandra
Author Greenberg, Lauren
Author Hunter, Rachael
Author Inderjeet Kaur
Author McCourt, Christine
Author Hatherall, Bethan
Author Findlay, Gail
Author Morris, Joanne
Author Reading, Sandra
Author Renton, Adrian
Author Adekoya, Ruth
Author Green, Belinda
Author Harvey, Belinda
Author Latham, Sarah
Author Patel, Kanta
Author Vanlessen, Logan
Author Harden, Angela
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Collected From Datacite
Hosted By figshare
Publication Date 2018-01-01
Publisher Figshare
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Language UNKNOWN
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keyword FOS: Sociology
keyword FOS: Biological sciences
system:type other
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Source https://science-innovation-policy.openaire.eu/search/other?orpId=dedup_wf_001::5bf38cfb308a384b855c239e91747f7a
Author jsonws_user
Last Updated 20 December 2020, 03:11 (CET)
Created 20 December 2020, 03:11 (CET)