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Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)-a stepped wedge cluster randomized controlled trial in public hospitals.
Implement Sci 2019; 14(1):65IS

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.

Authors+Show Affiliations

Golden Community, Jwagal, Lalitpur, Nepal.Ministry of Health and Population, Government of Nepal, Kathmandu, Nepal.Nepal Health Research Council, Ramshah Path, Kathmandu, Nepal.Golden Community, Jwagal, Lalitpur, Nepal.Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, Uppsala, Sweden.Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, Uppsala, Sweden.Ministry of Health and Population, Government of Nepal, Kathmandu, Nepal.Anweshan, Lalitpur, Nepal.Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, Uppsala, Sweden.Golden Community, Jwagal, Lalitpur, Nepal.Golden Community, Jwagal, Lalitpur, Nepal.Anweshan, Lalitpur, Nepal.Department of Paediatrics, Stavanger University Hospital, Våland burrough, Stavanger, Norway.Maternal and Child Health Division, ICDDR,B, Dhaka, Bangladesh.Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, Uppsala, Sweden.Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, Uppsala, Sweden.University of Turku, Turku, Finland.Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, Uppsala, Sweden. aaashis7@yahoo.com. Society of Public Health Physicians Nepal, Lalitpur, Nepal. aaashis7@yahoo.com.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31217028

Citation

Gurung, Rejina, et al. "Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)-a Stepped Wedge Cluster Randomized Controlled Trial in Public Hospitals." Implementation Science : IS, vol. 14, no. 1, 2019, p. 65.
Gurung R, Jha AK, Pyakurel S, et al. Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)-a stepped wedge cluster randomized controlled trial in public hospitals. Implement Sci. 2019;14(1):65.
Gurung, R., Jha, A. K., Pyakurel, S., Gurung, A., Litorp, H., Wrammert, J., ... Kc, A. (2019). Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)-a stepped wedge cluster randomized controlled trial in public hospitals. Implementation Science : IS, 14(1), p. 65. doi:10.1186/s13012-019-0917-z.
Gurung R, et al. Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)-a Stepped Wedge Cluster Randomized Controlled Trial in Public Hospitals. Implement Sci. 2019 06 19;14(1):65. PubMed PMID: 31217028.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)-a stepped wedge cluster randomized controlled trial in public hospitals. AU - Gurung,Rejina, AU - Jha,Anjani Kumar, AU - Pyakurel,Susheel, AU - Gurung,Abhishek, AU - Litorp,Helena, AU - Wrammert,Johan, AU - Jha,Bijay Kumar, AU - Paudel,Prajwal, AU - Rahman,Syed Moshfiqur, AU - Malla,Honey, AU - Sharma,Srijana, AU - Gautam,Manish, AU - Linde,Jorgen Erland, AU - Moinuddin,Md, AU - Ewald,Uwe, AU - Målqvist,Mats, AU - Axelin,Anna, AU - Kc,Ashish, Y1 - 2019/06/19/ PY - 2019/05/05/received PY - 2019/06/10/accepted PY - 2019/6/21/entrez PY - 2019/6/21/pubmed PY - 2019/8/27/medline KW - Basic neonatal resuscitation KW - Fetal heart rate monitoring KW - Nepal KW - Quality improvement interventions KW - Stepped wedge cluster randomized control trial SP - 65 EP - 65 JF - Implementation science : IS JO - Implement Sci VL - 14 IS - 1 N2 - 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. SN - 1748-5908 UR - https://www.unboundmedicine.com/medline/citation/31217028/Scaling_Up_Safer_Birth_Bundle_Through_Quality_Improvement_in_Nepal__SUSTAIN__a_stepped_wedge_cluster_randomized_controlled_trial_in_public_hospitals_ L2 - https://implementationscience.biomedcentral.com/articles/10.1186/s13012-019-0917-z DB - PRIME DP - Unbound Medicine ER -