CRADLE-5: a stepped-wedge type 2 hybrid implementation-effectiveness cluster randomised controlled trial to evaluate the real-world scale-up of the CRADLE Vital Signs Alert intervention into routine maternity care in Sierra Leone—study protocol

Trials

Study Protocol

Cristina Fernandez Turienzo¹  Alexandra E. Ridout¹  Lucy Chappell¹  Candace Beoku-Betts¹  Kate Bramham¹  Alice Hurrell¹  Jane Sandall¹  Katy Kuhrt¹  Andrew Shennan¹  Paul T. Seed¹  Sorie Samura²  Nicola Vousden³  Francis L. Moses⁴  Mariama Momoh⁴  Sartie Kenneh⁴  Francis Smart⁴  Simren Herm-Singh⁵  Daniel Kamara⁵  Venetia Goodhart⁵  Betty Sam⁵ 

[1] Department of Women and Children’s Health, School of Life Course and Population Sciences, King’s College London, Westminster Bridge Road, SE1 7EH, London, UK;National Emergency Medical Service, Ministry of Health and Sanitation, Freetown, Sierra Leone;National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK;Reproductive Health and Family Planning, Ministry of Health and Sanitation, Freetown, Sierra Leone;Welbodi Partnership, Freetown, Sierra Leone;

关键词: CRADLE;    Sierra Leone;    Low- and middle-income countries;    Pre-eclampsia;    Scale-up;    Shock;    Maternal mortality;    Blood pressure;    Complex intervention;    Stepped-wedge cluster trial;   

DOI  :  10.1186/s13063-023-07587-4

 received in 2023-06-20, accepted in 2023-08-16,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe CRADLE Vital Signs Alert intervention (an accurate easy-to-use device that measures blood pressure and pulse with inbuilt traffic-light early warning system, and focused training package) was associated with reduced rates of eclampsia and maternal death when trialled in urban areas in Sierra Leone. Subsequently, implementation was successfully piloted as evidenced by measures of fidelity, feasibility and adoption. The CRADLE-5 trial will examine whether national scale-up, including in the most rural areas, will reduce a composite outcome of maternal and fetal mortality and maternal morbidity and will evaluate how the CRADLE package can be embedded sustainably into routine clinical pathways.MethodsCRADLE-5 is a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care across eight rural districts in Sierra Leone (Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, Tonkolili). Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023). All women identified as pregnant or within six-weeks postpartum presenting for maternity care in the district are included. Primary outcome data (composite rate of maternal death, stillbirth, eclampsia and emergency hysterectomy) will be collected. A mixed-methods process and scale-up evaluation (informed by Medical Research Council guidance for complex interventions and the World Health Organization ExpandNet tools) will explore implementation outcomes of fidelity, adoption, adaptation and scale-up outcomes of reach, maintenance, sustainability and integration. Mechanisms of change and contextual factors (barriers and facilitators) will be assessed. A concurrent cost-effectiveness analysis will be undertaken.DiscussionInternational guidance recommends that all pregnant and postpartum women have regular blood pressure assessment, and healthcare staff are adequately trained to respond to abnormalities. Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated. This trial will explore whether national scale-up of the CRADLE intervention reduces maternal and fetal mortality and severe maternal adverse outcomes and understand the strategies for adoption, integration and sustainability in low-resource settings. If successful, the aim is to develop an adaptable, evidence-based scale-up roadmap to improve maternal and infant outcomes.Trial registrationISRCTN 94429427. Registered on 20 April 2022.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

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Fig. 4