. 2018 Mar 5;19(1):163.

doi: 10.1186/s13063-018-2526-6.

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

Mary Sawtell¹, Lorna Sweeney², Meg Wiggins³, Cathryn Salisbury², Sandra Eldridge⁴, Lauren Greenberg⁴, Rachael Hunter⁵, Inderjeet Kaur⁶, Christine McCourt⁷, Bethan Hatherall², Gail Findlay², Joanne Morris⁸, Sandra Reading⁶, Adrian Renton², Ruth Adekoya^{3

9}, Belinda Green¹⁰, Belinda Harvey¹¹, Sarah Latham¹², Kanta Patel¹³, Logan Vanlessen¹⁴, Angela Harden²

Affiliations

¹ Social Science Research Unit (SSRU), UCL Institute of Education, University College London, 18 Woburn Square, London, WC1H 0NR, UK. m.sawtell@ucl.ac.uk.
² Institute for Health and Human Development, University House, UH250, Stratford Campus, University of East London, Stratford Campus, London, E12 4LZ, UK.
³ Social Science Research Unit (SSRU), UCL Institute of Education, University College London, 18 Woburn Square, London, WC1H 0NR, UK.
⁴ Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
⁵ Department of Primary Care and Population Health, University College London, Royal Free Medical School, London, NW3 2PF, UK.
⁶ Barts Health NHS Trust, Royal London Hospital, Whitechapel Road, Whitechapel, London, E1 1BZ, UK.
⁷ School of Health Sciences, City University of London, Northampton Square, London, EC1V 0HB, UK.
⁸ Barts Health NHS Trust, Newham University Hospital, Glen Rd, Plaistow, London, E13 8SL, UK.
⁹ Lay Minister, London, UK.
¹⁰ University College London Hospitals NHS Foundation Trust, Elizabeth Garrett Anderson Wing, 25 Grafton Way, London, WC1E 6DB, UK.
¹¹ The Princess Alexandra Hospital NHS Trust, Hamstel Road, Harlow, Essex, CM20 1QX, UK.
¹² Homerton University Hospital NHS Foundation Trust, Homerton Row, London, E9 6SR, UK.
¹³ North Middlesex University Hospital NHS Trust, Sterling Way, London, N18 1QX, UK.
¹⁴ Whittington Health NHS Trust, Magdala Ave, London, N19 5NF, UK.

PMID: 29506563
PMCID: PMC5838929
DOI: 10.1186/s13063-018-2526-6

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

Mary Sawtell et al. Trials. 2018.

. 2018 Mar 5;19(1):163.

doi: 10.1186/s13063-018-2526-6.

Authors

Affiliations

¹ Social Science Research Unit (SSRU), UCL Institute of Education, University College London, 18 Woburn Square, London, WC1H 0NR, UK. m.sawtell@ucl.ac.uk.
² Institute for Health and Human Development, University House, UH250, Stratford Campus, University of East London, Stratford Campus, London, E12 4LZ, UK.
³ Social Science Research Unit (SSRU), UCL Institute of Education, University College London, 18 Woburn Square, London, WC1H 0NR, UK.
⁴ Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
⁵ Department of Primary Care and Population Health, University College London, Royal Free Medical School, London, NW3 2PF, UK.
⁶ Barts Health NHS Trust, Royal London Hospital, Whitechapel Road, Whitechapel, London, E1 1BZ, UK.
⁷ School of Health Sciences, City University of London, Northampton Square, London, EC1V 0HB, UK.
⁸ Barts Health NHS Trust, Newham University Hospital, Glen Rd, Plaistow, London, E13 8SL, UK.
⁹ Lay Minister, London, UK.
¹⁰ University College London Hospitals NHS Foundation Trust, Elizabeth Garrett Anderson Wing, 25 Grafton Way, London, WC1E 6DB, UK.
¹¹ The Princess Alexandra Hospital NHS Trust, Hamstel Road, Harlow, Essex, CM20 1QX, UK.
¹² Homerton University Hospital NHS Foundation Trust, Homerton Row, London, E9 6SR, UK.
¹³ North Middlesex University Hospital NHS Trust, Sterling Way, London, N18 1QX, UK.
¹⁴ Whittington Health NHS Trust, Magdala Ave, London, N19 5NF, UK.

PMID: 29506563
PMCID: PMC5838929
DOI: 10.1186/s13063-018-2526-6

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.

Keywords: Access to care; Antenatal care; Cluster randomised controlled trial; Co-production; Community engagement; Maternity.

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Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the NHS Health Research Authority National Research Ethics Committee North East-York (27 March 2015, ref.15/NE/0106) and the appropriate permissions for all the participating sites secured. All information collected during the trial will be kept confidential and adhere to the 1998 Data Protection Act.

There is no individual consent process for the outcomes evaluation due to the reliance on anonymous routine data. For the observation of community co-design workshops, participants were informed before the workshop began, that the researcher would not record any personal or identifiable data concerning anyone in attendance. Remaining in the workshop was interpreted as participants giving consent to the researcher making non-identifiable notes of the workshop processes. All potential survey and interview participants will be taken through information and consent procedures with verbal and written information provided before written consent is requested. Potential participants will be given adequate time to consider whether or not they want to participate – with contact details given to the research team should they want more time for this. Bilingual research assistants or health care interpreters (in antenatal clinics) will be included in the informed consent and data collection processes to provide language support where necessary.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 1**
Logic model for the Community REACH intervention

**Fig. 3**
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) schedule

See this image and copyright information in PMC

References

1. Marmot M, Allen J, Goldblatt P, et al. Fair society, healthy lives: strategic review of health inequalities in England post 2010. London: Marmot Review Team; 2010.
1. Oakley L, Gray R, Kurinczuk JJ, Brocklehurst P, Hollowell J. A systematic review of the effectiveness of interventions to increase the early initiation of antenatal care in socially disadvantaged and vulnerable women. Oxford: National Perinatal Epidemiology Unit; 2009.
1. Partridge S, Balayla J, Holcroft CA, Abenheim HA. Inadequate prenatal care utilization and risks of infant mortality and poor birth outcome: a retrospective analysis of 28,729,765 U.S. deliveries over 8 years. Am J Perinatol. 2012;29:787–794. doi: 10.1055/s-0032-1316439. - DOI - PubMed
1. Raatikainen K, Heiskanen N, Heinonen S. Under-attending free antenatal care is associated with adverse pregnancy outcomes. BMC Public Health. 2007; 10.1186/1471-2458-7-268. Accessed 30 Jan 17. - PMC - PubMed
1. National Institute for Health and Clinical Excellence . Antenatal Care for Uncomplicated Pregnancies: NICE guidelines [CG62] Manchester: National Institute for Health and Clinical Excellence; 2008. - PubMed

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical