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

Abstract

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 Electronic supplementary material The online version of this article (10.1186/s13012-019-0885-3) contains supplementary material, which is available to authorized users.

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“…Our approach assumed a relatively stable relationship between context, implementation and participant response [97] and have taken a snapshot of one point in time. However, some of the identified factors may have existed prior to the intervention, or there may have been a dynamic relationship that emerged during implementation which does not capture the effect of the context on the programme [50,98]. The causal pathway of the relationship between the three domains of context, implementation and participant response may not be fully understood and this study design may not have provided the means to understand the process.…”

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