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

on behalf of the CRADLE Trial Collaborative Group; Vousden, Nicola; Lawley, Elodie; Seed, Paul T.; Gidiri, Muchabayiwa Francis; Charantimath, Umesh; Makonyola, Grace; Brown, Adrian; Yadeta, Lomi; Best, Rebecca; Chinkoyo, Sebastian; Vwalika, Bellington; Nakimuli, Annettee; Ditai, James; Greene, Grace; Chappell, Lucy C.; Sandall, Jane; Shennan, Andrew H.

doi:10.1186/s13012-019-0885-3

Cited by 31Health Policy Implementation ScienceGlobal Maternal and Child HealthDelphi Technique in Research

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

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on behalf of the CRADLE Trial Collaborative Group, Vousden, Nicola, Lawley, Elodie, Seed, Paul T., Gidiri, Muchabayiwa Francis, Charantimath, Umesh, Makonyola, Grace, Brown, Adrian +10 more·2019·Implementation Science

DOI 10.1186/s13012-019-0885-3PMC PMC6471783

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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.

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A concurrent process evaluation across all CRADLE-3 trial sites found considerable variation in the implementation, reach, adoption and context.
“A concurrent process evaluation across all CRADLE-3 trial sites found considerable variation in the implementation, reach, adoption and context; analysis in individual countries was recommended [15].”
From 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 (2023) · cites this paper as [15]
In that process evaluation, no significant association was found between the composite 'implementation strength score' and the primary outcome (OR 0.93; 0.07-13.01).
“although no significant association was found between the composite ‘implementation strength score’ and the primary outcome (OR 0.93; 0.07–13.01).”
From Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption (2023) · cites this paper as [12]
A concurrent mixed-methods process evaluation found considerable variation in implementation, reach, adoption, and context between sites.
“A concurrent mixed-methods process evaluation found considerable variation in the implementation, reach, adoption, and context between sites, which may have contributed to variation in impact [12]”
From Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption (2023) · cites this paper as [12]
The CRADLE device was reported to support problem identification and management and met an urgent need for blood pressure machines.
“In keeping with the previous multi-site evaluation [12], the device was reported to support problem identification and management and met an urgent need for blood pressure machines.”
From Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption (2023) · cites this paper as [12]
Respondents generally found the CRADLE device easy to use, but small errors in application (e.g. incorrect positioning) could lead to staff mistrust.
“In keeping with earlier CRADLE studies [10, 12, 27], respondents generally found the device easy to use, but small errors in application (e.g. incorrect positioning) could lead to staff mistrust.”
From Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption (2023) · cites this paper as [12]

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Additional file 1 of Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption
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Additional file 2 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
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Additional file 9 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
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Additional file 5 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
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Additional file 7 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
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Additional file 1 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
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Additional file 3 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
Relph, S. A., Coxon, K., Vieira, M. C., Copas, A. J., Healey, A., Alagna, A., Briley, A., Johnson, M., Lawlor, D. A., Lees, C., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20968131
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Additional file 6 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
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Additional file 4 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
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Additional file 2 of Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption
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Additional file 10 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
Relph, S. A., Coxon, K., Vieira, M. C., Copas, A. J., Healey, A., Alagna, A., Briley, A., Johnson, M., Lawlor, D. A., Lees, C., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20968122
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Additional file 8 of Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
Relph, S. A., Coxon, K., Vieira, M. C., Copas, A. J., Healey, A., Alagna, A., Briley, A. L., Johnson, M., Lawlor, D. A., Lees, C., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20968146
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Additional file 1: of 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
Vousden, N., Lawley, E., Seed, P., Gidiri, M. F., Charantimath, U., Makonyola, G., Brown, A., Yadeta, L., Best, R. R., Chinkoyo, S., et al. (2019) · Figshare · doi:10.6084/m9.figshare.10034477
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Evaluating the real-world scale-up of the CRADLE Vital Signs Alert intervention into routine maternity care in Sierra Leone (CRADLE-5): a stepped-wedge, type 2 hybrid implementation–effectiveness, cluster-randomised controlled trial
Ridout, A. E., Moses, F., Herm-Singh, S., Beoku-Betts, C., Businge, E., Turienzo, C. F., Goodhart, V., Hurrell, A., Kamara, D., Kamara, J., et al. (2025) · The Lancet Obstetrics Gynaecology & Women s Health · doi:10.1016/j.lanogw.2025.09.003 · Cited by 6 · see citing works
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Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial
Vousden, N., Lawley, E., Nathan, H. L., Seed, P. T., Gidiri, M. F., Goudar, S., Sandall, J., Chappell, L. C., Shennan, A. H., Kachinjika, M., et al. (2019) · The Lancet Global Health · doi:10.1016/s2214-109x(18)30526-6 · Cited by 48 · see citing works
Self-citation
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
Ridout, A. E., Moses, F. L., Herm-Singh, S., Turienzo, C. F., Seed, P. T., Goodhart, V., Vousden, N., Sam, B., Momoh, M., Kamara, D., et al. (2023) · Trials · doi:10.1186/s13063-023-07587-4 · Cited by 8 · see citing works
Self-citation

Authors: on behalf of the CRADLE Trial Collaborative Group, Vousden, N., Lawley, E., Seed, P. T., Gidiri, M. F., Charantimath, U., Makonyola, G., Brown, A., Yadeta, L., Best, R., Chinkoyo, S., Vwalika, B., Nakimuli, A., Ditai, J., Greene, G., Chappell, L. C., Sandall, J., & Shennan, A. H.
Affiliations: King's College London (GB)
University of Zimbabwe (ZW)
Jawaharlal Nehru Medical College (IN)
University of Zambia (ZM)
Mulago Hospital (UG)
Mbale Hospital (UG)
Corresponding author: Vousden, Nicola
ORCID: Vousden, Nicola
Lawley, Elodie
Seed, Paul T.
Charantimath, Umesh
Chinkoyo, Sebastian
Vwalika, Bellington
Nakimuli, Annettee
Ditai, James
Chappell, Lucy C.
Sandall, Jane
Shennan, Andrew H.
Venue: Implementation Science
Publisher: Springer Science and Business Media LLC
Published: 2019-04-18
Volume: 14
Issue: 1
Pages: 38-38
ISSN: 1748-5908 (ISSN-L)
DOI: 10.1186/s13012-019-0885-3
PMC: PMC6471783
OpenAlex: W2946475705
Cited by: 31
References: 56
Citations by year: 2026: 1 · 2025: 2 · 2024: 3 · 2023: 7 · 2022: 12 · 2021: 3 · 2020: 2 · 2018: 1
FWCI: 5.79
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (tdm)
Locations: Implementation Science (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Research Explorer (The University of Manchester) (publishedVersion)
Research Portal (King's College London) (submittedVersion, cc-by)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
UTS ePRESS (University of Technology Sydney) (submittedVersion, other-oa)
Funders: Medical Research Council, Department of Biotechnology India and Department of International Development (MR/N006240/1)
Topics: Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Global Maternal and Child Health
Social Sciences › Sociology and Political Science › Delphi Technique in Research
Keywords: maternal mortality, obstetric care, resource-limited settings, complex interventions, implementation process evaluation, intervention uptake, health professions education, referral systems, maternal morbidity
MeSH terms: Implementation Science, Adult, Blood Pressure Determination, Developing Countries, Equipment Design, Female, Humans, Interviews as Topic, Maternal Mortality, Pregnancy, Triage, Program Evaluation, Program Development, Process Assessment, Health Care, Focus Groups, Hypertension, Pregnancy-Induced, Vital Signs

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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

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