Abstract
BackgroundInterventions 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.MethodsThe 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.ResultsOverall, 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.ConclusionsThis 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 registrationTrial registration: ISRCTN41244132. Registered on 2 Feb 2016
Highlights
Interventions aimed at reducing maternal mortality are increasingly complex
We suggest future trials should prioritise in-depth evaluation of local context and clinical pathways
In low- and middle-income countries (LMIC), challenges such as inadequate numbers of trained health care providers (HCP) [4] and insufficient access to reliable, accurate, equipment to monitor vital signs [5,6,7,8] lead to delays in identifying women with pregnancy complications which contributes to preventable mortality and morbidity [9, 10]
Summary
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. Knowing which components of an intervention and their delivery are necessary to produce an effect in a certain population is vital for results to be reproduced, adapted or scaled up. This is of even greater importance in low-resource countries with high burden of disease
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