Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)—a stepped wedge cluster randomized controlled trial in public hospitals

Abstract Background Each year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health fac...

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Main Authors: Rejina Gurung, Anjani Kumar Jha, Susheel Pyakurel, Abhishek Gurung, Helena Litorp, Johan Wrammert, Bijay Kumar Jha, Prajwal Paudel, Syed Moshfiqur Rahman, Honey Malla, Srijana Sharma, Manish Gautam, Jorgen Erland Linde, Md Moinuddin, Uwe Ewald, Mats Målqvist, Anna Axelin, Ashish KC
Format: Article
Language:English
Published: BMC 2019-06-01
Series:Implementation Science
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13012-019-0917-z
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author Rejina Gurung
Anjani Kumar Jha
Susheel Pyakurel
Abhishek Gurung
Helena Litorp
Johan Wrammert
Bijay Kumar Jha
Prajwal Paudel
Syed Moshfiqur Rahman
Honey Malla
Srijana Sharma
Manish Gautam
Jorgen Erland Linde
Md Moinuddin
Uwe Ewald
Mats Målqvist
Anna Axelin
Ashish KC
author_facet Rejina Gurung
Anjani Kumar Jha
Susheel Pyakurel
Abhishek Gurung
Helena Litorp
Johan Wrammert
Bijay Kumar Jha
Prajwal Paudel
Syed Moshfiqur Rahman
Honey Malla
Srijana Sharma
Manish Gautam
Jorgen Erland Linde
Md Moinuddin
Uwe Ewald
Mats Målqvist
Anna Axelin
Ashish KC
author_sort Rejina Gurung
collection DOAJ
description Abstract Background Each year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health facilities in these settings, the stillborn and neonatal mortality rates have not reduced proportionately. Poor quality of care in health facilities is attributed to two-thirds of these deaths. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. We aim to evaluate the quality improvement package—Scaling Up Safer Bundle Through Quality Improvement in Nepal (SUSTAIN)—on intrapartum care and intrapartum-related mortality in public hospitals of Nepal. Methods We will conduct a stepped wedge cluster randomized controlled trial in eight public hospitals with each having least 3000 deliveries a year. Each hospital will represent a cluster with an intervention transition period of 2 months in each. With a level of significance of 95%, the statistical power of 90% and an intra-cluster correlation of 0.00015, a study period of 19 months should detect at least a 15% change in intrapartum-related mortality. Quality improvement training, mentoring, systematic feedback, and a continuous improvement cycle will be instituted based on bottleneck analyses in each hospital. All concerned health workers will be trained on standard basic neonatal resuscitation and essential newborn care. Portable fetal heart monitors (Moyo®) and neonatal heart rate monitors (Neobeat®) will be introduced in the hospitals to identify fetal distress during labor and to improve neonatal resuscitation. Independent research teams will collect data in each hospital on intervention inputs, processes, and outcomes by reviewing records and carrying out observations and interviews. The dose-response effect will be evaluated through process evaluations. Discussion With the global momentum to improve quality of intrapartum care, better understanding of QI package within a health facility context is important. The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal. The proposed evaluation will provide evidence on QI package and technology for implementation and scale up in similar settings. Trial registration number ISRCTN16741720. Registered on 2 March 2019.
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spelling doaj.art-9a4e4f2766094213a137a7cc1542ec7c2022-12-21T23:57:16ZengBMCImplementation Science1748-59082019-06-011411910.1186/s13012-019-0917-zScaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)—a stepped wedge cluster randomized controlled trial in public hospitalsRejina Gurung0Anjani Kumar Jha1Susheel Pyakurel2Abhishek Gurung3Helena Litorp4Johan Wrammert5Bijay Kumar Jha6Prajwal Paudel7Syed Moshfiqur Rahman8Honey Malla9Srijana Sharma10Manish Gautam11Jorgen Erland Linde12Md Moinuddin13Uwe Ewald14Mats Målqvist15Anna Axelin16Ashish KC17Golden CommunityMinistry of Health and Population, Government of NepalNepal Health Research CouncilGolden CommunityDepartment of Women’s and Children’s Health, Uppsala UniversityDepartment of Women’s and Children’s Health, Uppsala UniversityMinistry of Health and Population, Government of NepalAnweshanDepartment of Women’s and Children’s Health, Uppsala UniversityGolden CommunityGolden CommunityAnweshanDepartment of Paediatrics, Stavanger University HospitalMaternal and Child Health Division, ICDDR,BDepartment of Women’s and Children’s Health, Uppsala UniversityDepartment of Women’s and Children’s Health, Uppsala UniversityUniversity of TurkuDepartment of Women’s and Children’s Health, Uppsala UniversityAbstract Background Each year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health facilities in these settings, the stillborn and neonatal mortality rates have not reduced proportionately. Poor quality of care in health facilities is attributed to two-thirds of these deaths. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. We aim to evaluate the quality improvement package—Scaling Up Safer Bundle Through Quality Improvement in Nepal (SUSTAIN)—on intrapartum care and intrapartum-related mortality in public hospitals of Nepal. Methods We will conduct a stepped wedge cluster randomized controlled trial in eight public hospitals with each having least 3000 deliveries a year. Each hospital will represent a cluster with an intervention transition period of 2 months in each. With a level of significance of 95%, the statistical power of 90% and an intra-cluster correlation of 0.00015, a study period of 19 months should detect at least a 15% change in intrapartum-related mortality. Quality improvement training, mentoring, systematic feedback, and a continuous improvement cycle will be instituted based on bottleneck analyses in each hospital. All concerned health workers will be trained on standard basic neonatal resuscitation and essential newborn care. Portable fetal heart monitors (Moyo®) and neonatal heart rate monitors (Neobeat®) will be introduced in the hospitals to identify fetal distress during labor and to improve neonatal resuscitation. Independent research teams will collect data in each hospital on intervention inputs, processes, and outcomes by reviewing records and carrying out observations and interviews. The dose-response effect will be evaluated through process evaluations. Discussion With the global momentum to improve quality of intrapartum care, better understanding of QI package within a health facility context is important. The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal. The proposed evaluation will provide evidence on QI package and technology for implementation and scale up in similar settings. Trial registration number ISRCTN16741720. Registered on 2 March 2019.http://link.springer.com/article/10.1186/s13012-019-0917-zQuality improvement interventionsBasic neonatal resuscitationFetal heart rate monitoringStepped wedge cluster randomized control trialNepal
spellingShingle Rejina Gurung
Anjani Kumar Jha
Susheel Pyakurel
Abhishek Gurung
Helena Litorp
Johan Wrammert
Bijay Kumar Jha
Prajwal Paudel
Syed Moshfiqur Rahman
Honey Malla
Srijana Sharma
Manish Gautam
Jorgen Erland Linde
Md Moinuddin
Uwe Ewald
Mats Målqvist
Anna Axelin
Ashish KC
Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)—a stepped wedge cluster randomized controlled trial in public hospitals
Implementation Science
Quality improvement interventions
Basic neonatal resuscitation
Fetal heart rate monitoring
Stepped wedge cluster randomized control trial
Nepal
title Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)—a stepped wedge cluster randomized controlled trial in public hospitals
title_full Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)—a stepped wedge cluster randomized controlled trial in public hospitals
title_fullStr Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)—a stepped wedge cluster randomized controlled trial in public hospitals
title_full_unstemmed Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)—a stepped wedge cluster randomized controlled trial in public hospitals
title_short Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)—a stepped wedge cluster randomized controlled trial in public hospitals
title_sort scaling up safer birth bundle through quality improvement in nepal sustain a stepped wedge cluster randomized controlled trial in public hospitals
topic Quality improvement interventions
Basic neonatal resuscitation
Fetal heart rate monitoring
Stepped wedge cluster randomized control trial
Nepal
url http://link.springer.com/article/10.1186/s13012-019-0917-z
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