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). https://doi.org/10.1186/s13063-018-2526-6
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
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Digital Object Identifier (DOI)https://doi.org/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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Smith, N. R., Clark, C., Fahy, A. E., Tharmaratnam, V., Lewis, D. J., Thompson, C., Renton, A., Moore, D., Bhui, K. S., Taylor, S. J. C., Eldridge, S., Petticrew, M., Greenhalgh, T., Stansfeld, S. A. and Cummins, S. 2012. The Olympic Regeneration in East London (ORiEL) study: protocol for a prospective controlled quasi-experiment to evaluate the impact of urban regeneration on young people and their families. BMJ Open. 2 (4), p. e001840.
The school environment and student health: a systematic review and meta-ethnography of qualitative research
Jamal, Farah, Fletcher, Adam, Harden, A., Wells, Helene, Thomas, James and Bonell, Chris 2013. The school environment and student health: a systematic review and meta-ethnography of qualitative research. BMC Public Health. 13 (1), p. 798.
Key barriers to community cohesion: views from residents of 20 London deprived neighbourhoods
Bertotti, M., Adams-Eaton, F., Sheridan, K. and Renton, A. 2011. Key barriers to community cohesion: views from residents of 20 London deprived neighbourhoods. GeoJournal. 47 (2), pp. 168-183.
The contribution of a social enterprise to the building of social capital in a disadvantaged urban area of London
Bertotti, M., Harden, A., Renton, A. and Sheridan, K. 2012. The contribution of a social enterprise to the building of social capital in a disadvantaged urban area of London. Community Development Journal. 47 (2), pp. 168-183.
Think of your art-eries: Arts participation, behavioural cardiovascular risk factors and mental well-being in deprived communities in London
Renton, A., Phillips, Gemma, Daykin, N, Yu, Ge, Taylor, K and Petticrew, Mark 2012. Think of your art-eries: Arts participation, behavioural cardiovascular risk factors and mental well-being in deprived communities in London. Public Health. 126 (Supp 1), pp. S57-S64.
A multilevel analysis of the association between social networks and support on leisure time physical activity: evidence from 40 disadvantaged areas in London
Yu, Ge, Renton, A., Schmidt, Elena, Tobi, Patrick, Bertotti, M., Watts, P. and Lais, Shahana 2011. A multilevel analysis of the association between social networks and support on leisure time physical activity: evidence from 40 disadvantaged areas in London. Health & Place. 17 (5), pp. 1023-1029.
A scoping review of the evidence relevant to life checks for young people aged 9 to 14 years
Harden, A. 2007. A scoping review of the evidence relevant to life checks for young people aged 9 to 14 years. London EPPI-Centre, Social Science Research Unit, Institute of Education, University of London.
Thematic synthesis
Harden, A. and Thomas, James 2008. Thematic synthesis. ESRC Research Methods Festival. St Catherine’s College, Oxford 30 Jun - 03 Jul 2008 Southampton ESRC National Centre for Research Methods.
Testing and building theories: mixed methods synthesis
Harden, A. 2008. Testing and building theories: mixed methods synthesis. ESRC Research Methods Festival. St Catherine’s College, Oxford 30 Jun - 03 Jul 2008 Southampton ESRC National Centre for Research Methods.
Critical appraisal and qualitative research: exploring sensitivity analysis
Harden, A. 2008. Critical appraisal and qualitative research: exploring sensitivity analysis. ESRC Research Methods Festival. St Catherine’s College, Oxford 30 Jun - 03 Jul 2008
Social and environmental interventions to reduce childhood obesity: a systematic map of reviews
Harden, A. 2008. Social and environmental interventions to reduce childhood obesity: a systematic map of reviews. London EPPI-Centre, Social Science Research Unit, Institute of Education, University of London.
Including diverse groups of children and young people in health promotion and public health research: a review of methodology and practice
Harden, A. 2008. Including diverse groups of children and young people in health promotion and public health research: a review of methodology and practice. London EPPI-Centre, Social Science Research Unit, Institute of Education, University of London.
Health promotion, inequalities and young people’s health: a systematic review of research
Harden, A. 2008. Health promotion, inequalities and young people’s health: a systematic review of research. London EPPI-Centre, Social Science Research Unit, Institute of Education, University of London.
A review of effectiveness, including cost effectiveness wherever possible, of commissioned healthy weight-related projects in City and Hackney: final report
Harden, A., Estacio, Emee Vida, Tobi, Patrick, Adams-Eaton, Faye, Bertotti, Marcello and Lais, Shahana 2009. A review of effectiveness, including cost effectiveness wherever possible, of commissioned healthy weight-related projects in City and Hackney: final report. London Institute of Health and Human Development, University of East London.
A project to assist Family Actions's Building Bridges practitioners with the use of the Index of Family Relations as an outcome measurement: final report
Harden, A., Lloyd-Reichling, E., Mcdermott, M., Potter, Sylvia and Sayeed, Zahirun 2009. A project to assist Family Actions's Building Bridges practitioners with the use of the Index of Family Relations as an outcome measurement: final report. London University of East London.
The Well London program - a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results
Phillips, G., Renton, A., Moore, D., Bottomley, Christian, Schmidt, Elena, Lais, Shahana, Yu, Ge, Wall, Martin, Tobi, P., Frostick, C., Clow, Angela, Lock, Karen, Petticrew, Mark and Hayes, Richard 2012. The Well London program - a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results. Trials. 13 (105).
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), pp. 1471-2288.
The influence of environmental factors on the generalisability of public health research evidence: physical activity as a worked example
Watts, P., Phillips, Gemma, Harden, A. and Renton, A. 2011. The influence of environmental factors on the generalisability of public health research evidence: physical activity as a worked example. International Journal of Behavioural Nutrition and Physical Activity. 8 (1), pp. 1479-5868.
Creating and Maintaining a Healthy Stratford City: Principles and Practices for Success
Sampson, Alice, Harden, A., Brimicombe, A., Bertotti, Marcello, Lais, Shahana, Barrow-Guevera, Gail, Boniwell, Ilona, Joseph, Hipolina, Sheridan, Kevin, Adams-Eaton, Faye, Tobi, Patrick and Li, Yang 2010. Creating and Maintaining a Healthy Stratford City: Principles and Practices for Success. University of East London, Centre for Institutional Studies.
Protocol for a systematic review of the effects of schools and school-environment interventions on health: evidence mapping and syntheses
Harden, A. and Jamal, Farah 2011. Protocol for a systematic review of the effects of schools and school-environment interventions on health: evidence mapping and syntheses. BMC Public Health. 11 (453).
Antiretroviral treatment and the health workforce in South Africa: how have ART workers been affected by scaling up?
Tobi, Patrick, George, Gavin, Schmidt, Elena and Renton, A. 2008. Antiretroviral treatment and the health workforce in South Africa: how have ART workers been affected by scaling up? Tropical Medicine and International Health. 13 (12), pp. 1452-1458.
Integrating qualitative research with trials in systematic reviews
Thomas, James, Harden, A., Oakley, Ann, Oliver, Sandy, Sutcliffe, Katy, Rees, Rebecca, Brunton, Ginny and Kavanagh, Josephine 2004. Integrating qualitative research with trials in systematic reviews. British Medical Journal. 328 (7446), pp. 1010-1012.
Applying systematic review methods to studies of people’s views: an example from public health research
Harden, A., Garcia, Jo, Oliver, Sandy, Rees, Rebecca, Shepherd, Jonathan, Brunton, Ginny and Oakley, Ann 2004. Applying systematic review methods to studies of people’s views: an example from public health research. Journal of Epidemiology and Community Health. 58 (9), pp. 794-800.
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).
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).