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.
Adult
Blood Pressure Determination
/ instrumentation
Developing Countries
Equipment Design
Female
Focus Groups
Humans
Hypertension, Pregnancy-Induced
/ diagnosis
Implementation Science
Interviews as Topic
Maternal Mortality
Pregnancy
Process Assessment, Health Care
Program Development
Program Evaluation
Triage
Vital Signs
Complex intervention
Global health
Hybrid trial
Implementation strength
Maternal mortality
Journal
Implementation science : IS
ISSN: 1748-5908
Titre abrégé: Implement Sci
Pays: England
ID NLM: 101258411
Informations de publication
Date de publication:
18 04 2019
18 04 2019
Historique:
received:
23
10
2018
accepted:
28
03
2019
entrez:
20
4
2019
pubmed:
20
4
2019
medline:
27
8
2019
Statut:
epublish
Résumé
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. 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. 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. 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: ISRCTN41244132 . Registered on 2 Feb 2016.
Sections du résumé
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.
Identifiants
pubmed: 30999963
doi: 10.1186/s13012-019-0885-3
pii: 10.1186/s13012-019-0885-3
pmc: PMC6471783
doi:
Banques de données
ISRCTN
['ISRCTN41244132']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
38Subventions
Organisme : Medical Research Council
ID : MR/N006240/1
Pays : United Kingdom
Organisme : Medical Research Council, Department of Biotechnology India and Department of International Development
ID : MR/N006240/1
Pays : International
Organisme : Department of Health
ID : RP-2014-05-019
Pays : United Kingdom
Investigateurs
Doreen Bukani
(D)
Paul Toussaint
(P)
Adeline Vixama
(A)
Carywyn Hill
(C)
Emily Nakirijja
(E)
Doreen Birungi
(D)
Noela Kalyowa
(N)
Dorothy Namakuli
(D)
Josaphat Byamugisha
(J)
Nathan Mackayi Odeke
(NM)
Julius Wandabwa
(J)
Fatmata Momodou
(F)
Margaret Sesay
(M)
Patricia Sandi
(P)
Jeneba Conteh
(J)
Jesse Kamara
(J)
Matthew Clarke
(M)
Josephine Miti
(J)
Martina Chima
(M)
Mercy Kopeka
(M)
Bellington Vwalika
(B)
Christine Jere
(C)
Thokozile Musonda
(T)
Violet Mambo
(V)
Yonas Guchale
(Y)
Feiruz Surur
(F)
Geetanjali M Mungarwadi
(GM)
Sphoorthi S Mastiholi
(SS)
Chandrappa C Karadiguddi
(CC)
Natasha Hezelgrave
(N)
Kate E Duhig
(KE)
Monice Kachinjika
(M)
Mrutyunjaya Bellad
(M)
Jane Makwakwa
(J)
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