A structured training program for health workers in intravenous treatment with fluids and antibiotics in nursing homes: A modified stepped-wedge cluster-randomised trial to reduce hospital admissions

Abstract Background Neonatal mortality remains unacceptably high. Many studies successful at reducing neonatal mortality have failed to realise similar gains at scale. Effective implementation and scale-up of interventions designed to tackle neonatal mortality is a global health priority. Multifaceted programmes targeting the continuum of neonatal care, with sustainability and scalability built into the design, can provide practical insights to solve this challenge. Cambodia has amongst the highest neonatal mortality rates in South-East Asia, with rural areas particularly affected. The primary objective of this study is the design, implementation, and assessment of the Saving Babies’ Lives programme, a package of interventions designed to reduce neonatal mortality in rural Cambodia. Methods This study is a five-year stepped-wedge cluster-randomised trial conducted in a rural Cambodian province with an estimated annual delivery rate of 6615. The study is designed to implement and evaluate the Saving Babies’ Lives programme, which is the intervention. The Saving Babies’ Lives programme is an iterative package of neonatal interventions spanning the continuum of care and integrating into the existing health system. The Saving Babies’ Lives programme comprises two major components: participatory learning and action with community health workers, and capacity building of primary care facilities involving facility-based mentorship. Standard government service continues in control arms. Data collection covering the whole study area includes surveillance of all pregnancies, verbal and social autopsies, and quality of care surveys. Mixed methods data collection supports iteration of the complex intervention, and facilitates impact, outcome, process and economic evaluation. Discussion Our study uses a robust study design to evaluate and develop a holistic, innovative, contextually relevant and sustainable programme that can be scaled-up to reduce neonatal mortality. Trial registration ClinicalTrials.gov: NCT04663620. Registered on 11th December 2020, retrospectively registered.

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Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda

BMC Health Services Research ◽

10.1186/s12913-021-07155-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Joseph Akuze ◽

Kristi Sidney Annerstedt ◽

Lenka Benova ◽

Effie Chipeta ◽

Jean-Paul Dossou ◽

...

Keyword(s):

Perinatal Mortality ◽

Process Evaluation ◽

Study Protocol ◽

Health Workers ◽

Randomised Trial ◽

User Participation ◽

Cluster Randomised Trial ◽

Evidence Based ◽

Stepped Wedge ◽

Cluster Randomised

Abstract Background Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period. Methods This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial’s primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention. Discussion There is evidence that each of the ALERT intervention components improves health providers’ practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions. Trial registration Pan African Clinical Trial Registry (www.pactr.org): PACTR202006793783148. Registered on 17th June 2020.

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Correction: Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial

PLoS Medicine ◽

10.1371/journal.pmed.1002993 ◽

2019 ◽

Vol 16 (12) ◽

pp. e1002993

Author(s):

Nina Østerås ◽

Tuva Moseng ◽

Leti van Bodegom-Vos ◽

Krysia Dziedzic ◽

Ibrahim Mdala ◽

...

Keyword(s):

Primary Healthcare ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Structured Model ◽

Cluster Randomised

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Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial

PLoS Medicine ◽

10.1371/journal.pmed.1002175 ◽

2016 ◽

Vol 13 (11) ◽

pp. e1002175 ◽

Cited By ~ 54

Author(s):

Badara Cissé ◽

El Hadj Ba ◽

Cheikh Sokhna ◽

Jean Louis NDiaye ◽

Jules F. Gomis ◽

...

Keyword(s):

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Cluster Randomised ◽

Seasonal Malaria Chemoprevention

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Improving quality of care during childbirth in primary health centres: a stepped-wedge cluster-randomised trial in India

BMJ Global Health ◽

10.1136/bmjgh-2018-000907 ◽

2018 ◽

Vol 3 (5) ◽

pp. e000907 ◽

Cited By ~ 3

Author(s):

Ramesh Agarwal ◽

Deepak Chawla ◽

Minakshi Sharma ◽

Shyama Nagaranjan ◽

Suresh K Dalpath ◽

...

Keyword(s):

Quality Of Care ◽

Management Strategy ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Primary Health ◽

Cluster Randomised ◽

Primary Health Centres ◽

Health Centres

BackgroundLow/middle-income countries need a large-scale improvement in the quality of care (QoC) around the time of childbirth in order to reduce high maternal, fetal and neonatal mortality. However, there is a paucity of scalable models.MethodsWe conducted a stepped-wedge cluster-randomised trial in 15 primary health centres (PHC) of the state of Haryana in India to test the effectiveness of a multipronged quality management strategy comprising capacity building of providers, periodic assessments of the PHCs to identify quality gaps and undertaking improvement activities for closure of the gaps. The 21-month duration of the study was divided into seven periods (steps) of 3 months each. Starting from the second period, a set of randomly selected three PHCs (cluster) crossed over to the intervention arm for rest of the period of the study. The primary outcomes included the number of women approaching the PHCs for childbirth and 12 directly observed essential practices related to the childbirth. Outcomes were adjusted with random effect for cluster (PHC) and fixed effect for ‘months of intervention’.ResultsThe intervention strategy led to increase in the number of women approaching PHCs for childbirth (26 vs 21 women per PHC-month, adjusted incidence rate ratio: 1.22; 95% CI 1.17 to 1.28). Of the 12 practices, 6 improved modestly, 2 remained near universal during both intervention and control periods, 3 did not change and 1 worsened. There was no evidence of change in mortality with a majority of deaths occurring either during referral transport or at the referral facilities.ConclusionA multipronged quality management strategy enhanced utilisation of services and modestly improved key practices around the time of childbirth in PHCs in India.Trial registration numberCTRI/2016/05/006963.

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