Exploring the effect of implementation and context on a stepped-wedge randomised controlled trial of a vital sign triage device in routine maternity care in low-resource settings

Nicola Vousden*, Elodie Lawley, Paul T. Seed, Muchabayiwa Francis Gidiri, Umesh Charantimath, Grace Makonyola, Adrian Brown, Lomi Yadeta, Rebecca Best, Sebastian Chinkoyo, Bellington Vwalika, Annettee Nakimuli, James Ditai, Grace Greene, Lucy C. Chappell, Jane Sandall, Andrew H. Shennan, Doreen Bukani, Paul Toussaint, Adeline VixamaCarywyn Hill, Emily Nakirijja, Doreen Birungi, Noela Kalyowa, Dorothy Namakuli, Josaphat Byamugisha, Nathan Mackayi Odeke, Julius Wandabwa, Fatmata Momodou, Margaret Sesay, Patricia Sandi, Jeneba Conteh, Jesse Kamara, Matthew Clarke, Josephine Miti, Martina Chima, Mercy Kopeka, Christine Jere, Thokozile Musonda, Violet Mambo, Yonas Guchale, Feiruz Surur, Geetanjali M. Mungarwadi, Sphoorthi S. Mastiholi, Chandrappa C. Karadiguddi, Natasha Hezelgrave, Kate E. Duhig, Monice Kachinjika, Mrutyunjaya Bellad, Jane Makwakwa

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

12 Citations (Scopus)
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Background: Interventions aimed at reducing maternal mortality are increasingly complex. Understanding how complex interventions are delivered, to whom, and how they work is key in ensuring their rapid scale-up. We delivered a vital signs triage intervention into routine maternity care in eight low- and middle-income countries with the aim of reducing a composite outcome of morbidity and mortality. This was a pragmatic, hybrid effectiveness-implementation stepped-wedge randomised controlled trial. In this study, we present the results of the mixed-methods process evaluation. The aim was to describe implementation and local context and integrate results to determine whether differences in the effect of the intervention across sites could be explained. Methods: The duration and content of implementation, uptake of the intervention and its impact on clinical management were recorded. These were integrated with interviews (n = 36) and focus groups (n = 19) at 3 months and 6-9 months after implementation. In order to determine the effect of implementation on effectiveness, measures were ranked and averaged across implementation domains to create a composite implementation strength score and then correlated with the primary outcome. Results: Overall, 61.1% (n = 2747) of health care providers were trained in the intervention (range 16.5% to 89.2%) over a mean of 10.8 days. Uptake and acceptability of the intervention was good. All clusters demonstrated improved availability of vital signs equipment. There was an increase in the proportion of women having their blood pressure measured in pregnancy following the intervention (79.2% vs. 97.6%; OR 1.30 (1.29-1.31)) and no significant change in referral rates (3.7% vs. 4.4% OR 0.89; (0.39-2.05)). Availability of resources and acceptable, effective referral systems influenced health care provider interaction with the intervention. There was no correlation between process measures within or between domains, or between the composite score and the primary outcome. Conclusions: This process evaluation has successfully described the quantity and quality of implementation. Variation in implementation and context did not explain differences in the effectiveness of the intervention on maternal mortality and morbidity. We suggest future trials should prioritise in-depth evaluation of local context and clinical pathways. Trial registration: Trial registration: ISRCTN41244132. Registered on 2 Feb 2016.

Original languageEnglish
Article number38
JournalImplementation Science
Issue number1
Publication statusPublished - 18 Apr 2019


  • Complex intervention
  • Global health
  • Hybrid trial
  • Implementation strength
  • Maternal mortality


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