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 Vixama; Carywyn 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

doi:10.1186/s13012-019-0885-3

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

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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.

Original language	English
Article number	38
Journal	Implementation Science
Volume	14
Issue number	1
DOIs	https://doi.org/10.1186/s13012-019-0885-3
Publication status	Published - 18 Apr 2019

Keywords

Complex intervention
Global health
Hybrid trial
Implementation strength
Maternal mortality

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Exploring the effect_VOUSDEN_Accepted28March2019_GOLD VoRFinal published version, 2.29 MBLicence: CC BY

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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., Bukani, D., Toussaint, P., ... Makwakwa, J. (2019). 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. Implementation Science, 14(1), [38]. https://doi.org/10.1186/s13012-019-0885-3

@article{d4972ee9464f47d58bb796a62e989641,

title = "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.",

keywords = "Complex intervention, Global health, Hybrid trial, Implementation strength, Maternal mortality",

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

year = "2019",

month = apr,

day = "18",

doi = "10.1186/s13012-019-0885-3",

language = "English",

volume = "14",

journal = "Implementation Science",

issn = "1748-5908",

publisher = "BioMed Central",

number = "1",

}

Vousden, N , Lawley, E , Seed, PT, Gidiri, MF, Charantimath, U, Makonyola, G, Brown, A, Yadeta, L, Best, R, Chinkoyo, S, Vwalika, B, Nakimuli, A, Ditai, J, Greene, G, Chappell, LC , Sandall, J , Shennan, AH, Bukani, D, Toussaint, P, Vixama, A, Hill, C, Nakirijja, E, Birungi, D, Kalyowa, N, Namakuli, D, Byamugisha, J, Odeke, NM, Wandabwa, J, Momodou, F, Sesay, M, Sandi, P, Conteh, J, Kamara, J, Clarke, M, Miti, J, Chima, M, Kopeka, M, Jere, C, Musonda, T, Mambo, V, Guchale, Y, Surur, F, Mungarwadi, GM, Mastiholi, SS, Karadiguddi, CC, Hezelgrave, N , Duhig, KE, Kachinjika, M, Bellad, M & Makwakwa, J 2019, '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', Implementation Science, vol. 14, no. 1, 38. https://doi.org/10.1186/s13012-019-0885-3

TY - JOUR

T1 - 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

AU - Vousden, Nicola

AU - Lawley, Elodie

AU - Seed, Paul T.

AU - Gidiri, Muchabayiwa Francis

AU - Charantimath, Umesh

AU - Makonyola, Grace

AU - Brown, Adrian

AU - Yadeta, Lomi

AU - Best, Rebecca

AU - Chinkoyo, Sebastian

AU - Vwalika, Bellington

AU - Nakimuli, Annettee

AU - Ditai, James

AU - Greene, Grace

AU - Chappell, Lucy C.

AU - Sandall, Jane

AU - Shennan, Andrew H.

AU - Bukani, Doreen

AU - Toussaint, Paul

AU - Vixama, Adeline

AU - Hill, Carywyn

AU - Nakirijja, Emily

AU - Birungi, Doreen

AU - Kalyowa, Noela

AU - Namakuli, Dorothy

AU - Byamugisha, Josaphat

AU - Odeke, Nathan Mackayi

AU - Wandabwa, Julius

AU - Momodou, Fatmata

AU - Sesay, Margaret

AU - Sandi, Patricia

AU - Conteh, Jeneba

AU - Kamara, Jesse

AU - Clarke, Matthew

AU - Miti, Josephine

AU - Chima, Martina

AU - Kopeka, Mercy

AU - Jere, Christine

AU - Musonda, Thokozile

AU - Mambo, Violet

AU - Guchale, Yonas

AU - Surur, Feiruz

AU - Mungarwadi, Geetanjali M.

AU - Mastiholi, Sphoorthi S.

AU - Karadiguddi, Chandrappa C.

AU - Hezelgrave, Natasha

AU - Duhig, Kate E.

AU - Kachinjika, Monice

AU - Bellad, Mrutyunjaya

AU - Makwakwa, Jane

PY - 2019/4/18

Y1 - 2019/4/18

N2 - 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.

AB - 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.

KW - Complex intervention

KW - Global health

KW - Hybrid trial

KW - Implementation strength

KW - Maternal mortality

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U2 - 10.1186/s13012-019-0885-3

DO - 10.1186/s13012-019-0885-3

M3 - Article

AN - SCOPUS:85064522866

SN - 1748-5908

VL - 14

JO - Implementation Science

JF - Implementation Science

IS - 1

M1 - 38

ER -

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

Keywords

UN SDGs

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