Effect of a scaled-up neonatal resuscitation quality improvement package on intrapartum-related mortality in Nepal: A stepped-wedge cluster randomized controlled trial

Improving quality of intrapartum care will reduce intrapartum stillbirth and neonatal mortality, especially in resource-poor settings. Basic neonatal resuscitation can reduce intrapartum stillbirth and early neonatal mortality, if delivered in a high-quality health system, but there is a dearth of e...

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Published in:	PLoS medicine Vol. 16; no. 9; p. e1002900
Main Authors:	Kc, Ashish, Ewald, Uwe, Basnet, Omkar, Gurung, Abhishek, Pyakuryal, Sushil Nath, Jha, Bijay Kumar, Bergström, Anna, Eriksson, Leif, Paudel, Prajwal, Karki, Sushil, Gajurel, Sunil, Brunell, Olivia, Wrammert, Johan, Litorp, Helena, Målqvist, Mats
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 09-09-2019 Public Library of Science (PLoS)
Subjects:	Accountability Adult adverse effects Analysis Apgar score Biology and Life Sciences Birth weight Childbirth & labor Clinical trials Control Correlation coefficient Correlation coefficients Data collection Demographics etiology Female Gestational age Health Health aspects Health Care Health Care Service and Management, Health Policy and Services and Health Economy Hospital Mortality Hospitals Hospitals, Public Humans Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi Incidence Infant Infant Mortality Infant, Newborn Infants Intensive Care Intensive Care Units Intensive Care Units, Neonatal Intensive Care, Neonatal - standards Intervention Low income groups Medical personnel Medical research Medicin och hälsovetenskap Medicine and Health Sciences Metric system Minority & ethnic groups Mortality Neonatal Neonates Nepal Newborn Newborn infants Parturition Pediatrics Pediatrik Perinatal Death Perinatal Death - etiology Perinatal Death - prevention & control Postpartum period Pregnancy prevention & control Public Public health Quality Quality control Quality Improvement Quality Indicators Quality Indicators, Health Care Quality of care Randomization Resuscitation Resuscitation - adverse effects Resuscitation - mortality Resuscitation - standards Risk Factors Scaling up Software Statistical models Stillbirth Supervision Sustainability Sustainable development Time Factors Treatment Outcome Wedges Womens health Workers Young Adult Nepal Sweden United States > US Tanzania Michigan
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Summary:	Improving quality of intrapartum care will reduce intrapartum stillbirth and neonatal mortality, especially in resource-poor settings. Basic neonatal resuscitation can reduce intrapartum stillbirth and early neonatal mortality, if delivered in a high-quality health system, but there is a dearth of evidence on how to scale up such evidence-based interventions. We evaluated the scaling up of a quality improvement (QI) package for neonatal resuscitation on intrapartum-related mortality (intrapartum stillbirth and first day mortality) at hospitals in Nepal. We conducted a stepped-wedge cluster randomized controlled trial in 12 hospitals over a period of 18 months from April 14, 2017, to October 17, 2018. The hospitals were assigned to one of four wedges through random allocation. The QI package was implemented in a stepped-wedge manner with a delay of three months for each step. The QI package included improving hospital leadership on intrapartum care, building health workers' competency on neonatal resuscitation, and continuous facilitated QI processes in clinical units. An independent data collection system was set up at each hospital to gather data on mortality through patient case note review and demographic characteristics of women using semi-structured exit interviews. The generalized linear mixed model (GLMM) and multivariate logistic regression were used for analyses. During this study period, a total of 89,014 women-infant pairs were enrolled. The mean age of the mother in the study period was 24.0 ± 4.3 years, with 54.9% from disadvantaged ethnic groups and 4.0% of them illiterate. Of the total birth cohort, 54.4% were boys, 16.7% had gestational age less than 37 weeks, and 17.1% had birth weight less than 2,500 grams. The incidence of intrapartum-related mortality was 11.0 per 1,000 births during the control period and 8.0 per 1,000 births during the intervention period (adjusted odds ratio [aOR], 0.79; 95% CI, 0.69-0.92; p = 0.002; intra-cluster correlation coefficient [ICC], 0.0286). The incidence of early neonatal mortality was 12.7 per 1,000 live births during the control period and 10.1 per 1,000 live births during the intervention period (aOR, 0.89; 95% CI, 0.78-1.02; p = 0.09; ICC, 0.1538). The use of bag-and-mask ventilation for babies with low Apgar score (<7 at 1 minute) increased from 3.2% in the control period to 4.0% in the intervention period (aOR, 1.52; 95% CI, 1.32-1.77, p = 0.003). There were two major limitations to the study; although a large sample of women-infant pairs were enrolled in the study, the clustering reduced the power of the study. Secondly, the study was not sufficiently powered to detect reduction in early neonatal mortality with the number of clusters provided. These results suggest scaled-up implementation of a QI package for neonatal resuscitation can reduce intrapartum-related mortality and improve clinical care. The QI intervention package is likely to be effective in similar settings. More implementation research is required to assess the sustainability of QI interventions and quality of care. ISRCTN30829654.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23 The authors have declared that no competing interests exist.
ISSN:	1549-1676 1549-1277 1549-1676
DOI:	10.1371/journal.pmed.1002900