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

Article


Sawtell, Mary, Sweeney, L., Wiggins, Meg, Salisbury, C., Eldridge, Sandra, Greenberg, Lauren, Hunter, Rachael, Kaur, Inderjeet, McCourt, Christine, Hatherall, B., Findlay, G., Morris, Joanne, Reading, Sandra, Renton, A., Adekoya, Ruth, Green, Belinda, Harvey, Belinda, Latham, Sarah, Patel, Kanta, VanLessen, Logan and Harden, A. 2018. 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. Trials. 19 (163).
AuthorsSawtell, Mary, Sweeney, L., Wiggins, Meg, Salisbury, C., Eldridge, Sandra, Greenberg, Lauren, Hunter, Rachael, Kaur, Inderjeet, McCourt, Christine, Hatherall, B., Findlay, G., Morris, Joanne, Reading, Sandra, Renton, A., Adekoya, Ruth, Green, Belinda, Harvey, Belinda, Latham, Sarah, Patel, Kanta, VanLessen, Logan and Harden, A.
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.

KeywordsAccess to care; Antenatal care; Cluster randomised controlled trial; Community engagement; Co-production; Maternity
JournalTrials
Journal citation19 (163)
ISSN1745-6215
Year2018
PublisherBioMed Central
Publisher's version
License
Digital Object Identifier (DOI)doi:10.1186/s13063-018-2526-6
Web address (URL)https://doi.org/10.1186/s13063-018-2526-6
Publication dates
Print05 Mar 2018
Publication process dates
Deposited28 Mar 2018
Accepted06 Feb 2018
Accepted06 Feb 2018
FunderNational Institute for Health Research
Copyright information© 2018 The authors
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Harden, A., Lloyd-Reichling, E., Mcdermott, M., Potter, Sylvia and Sayeed, Zahirun 2009. A project to assist Family Action’s Building Bridges practitioners with the use of the Index of Family Relations as an outcome measurement (Final Report). Family Action, Institute of Health and Human Development and CASS School of Education, University of East London.
Teenage pregnancy and social disadvantage: systematic review integrating controlled trials and qualitative studies
Harden, A., Brunton, Ginny, Fletcher, Adam and Oakley, Ann 2009. Teenage pregnancy and social disadvantage: systematic review integrating controlled trials and qualitative studies. British Medical Journal. 339 (121).
Evaluation of community level interventions to address social and structural determinants of health: a cluster randomised controlled trial
Wall, Martin, Hayes, Richard, Moore, D., Petticrew, Mark, Clow, Angela, Schmidt, Elena, Draper, Alizon, Lock, Karen, Lynch, Rebecca and Renton, A. 2009. Evaluation of community level interventions to address social and structural determinants of health: a cluster randomised controlled trial. BMC Public Health. 9 (207).
Methods for the thematic synthesis of qualitative research in systematic reviews
Thomas, James and Harden, A. 2008. Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Medical Research Methodology. 8 (45).