Sawtell Mary, Sweeney Lorna, Wiggins Meg, Salisbury Cathryn, Eldridge Sandra, Greenberg Lauren, Hunter Rachael, Kaur Inderjeet, McCourt Christine, Hatherall Bethan, Findlay Gail, Morris Joanne, Reading Sandra, Renton Adrian, Adekoya Ruth, Green Belinda, Harvey Belinda, Latham Sarah, Patel Kanta, Vanlessen Logan, Harden Angela
Social Science Research Unit (SSRU), UCL Institute of Education, University College London, 18 Woburn Square, London, WC1H 0NR, UK.
Institute for Health and Human Development, University House, UH250, Stratford Campus, University of East London, Stratford Campus, London, E12 4LZ, UK.
Trials. 2018 Mar 5;19(1):163. doi: 10.1186/s13063-018-2526-6.
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.
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.
ISRCTN registry: registration number 63066975 . Registered on 18 August 2015.
提供高质量的孕产妇服务是减少母婴健康结果不平等现象的优先事项。最佳做法包括妇女在怀孕的头三个月内进行首次产前检查，以便为孕期的健康生活方式、福祉和自我护理提供筛查和支持。先前的研究已经确定了获得产前护理方面的不平等现象，但几乎没有证据表明有哪些干预措施可以改善产前护理的早期开始。社区REACH试验将评估让社区共同参与制定和实施一项解决该问题的干预措施的有效性和成本效益。
方法/设计：本研究设计为一项匹配整群随机对照试验，同时进行综合过程和经济评估。随机分组的单位是选区。干预措施将在10个选区实施；10个对照选区将维持常规做法。主要结局是在怀孕满12周时进行产前预约就诊的孕妇比例。对于在纳入选区完成干预措施实施后2至7个月和8至13个月分娩的女性队列（每组约1450人），将使用常规收集的孕产妇数据来评估这一结局以及一些次要结局。已招募了八家受委托在伦敦北部和东部以及埃塞克斯郡的六个国民保健服务信托基金中提供孕产妇服务的医院参与该研究。这些信托基金将提供用于随机分组和结局分析的匿名常规数据。过程评估将考察干预措施的实施情况、可接受性、覆盖范围以及可能的因果途径。经济评估将使用成本后果分析和决策模型来评估干预措施。在研究过程中有针对性地让社区参与是一个优先事项。
社区REACH旨在通过一项由当地社区共同制定和实施的干预措施来提高产前护理的早期开始率。这项务实的整群随机对照试验，同时进行综合过程和经济评估，旨在严格评估这项公共卫生干预措施的有效性，由于需要将标准化与当地灵活性相结合，这项干预措施特别复杂。它还将回答有关可扩展性和普遍性的问题。
国际标准随机对照试验编号注册库：注册号63066975。于2015年8月18日注册。
