Study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high-quality early essential newborn care in Lao PDR
Abstract Background Reduction in neonatal deaths has been a major challenge globally. To prevent neonatal deaths, improvements in newborn care have been promoted worldwide. The World Health Organization Western Pacific Regional Office has been promoting the Early Essential Newborn Care (EENC), a pac...
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| Format: | Article |
| Language: | English |
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BMC
2018-06-01
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| Series: | BMC Health Services Research |
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| Online Access: | http://link.springer.com/article/10.1186/s12913-018-3311-7 |
| _version_ | 1811287919688679424 |
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| author | Sayaka Horiuchi Sommana Rattana Bounnack Saysanasongkham Outhevanh Kounnavongsa Shogo Kubota Julie Cayrol Kenzo Takahashi Mariko Inoue Asuka Nemoto Kazue Yamaoka |
| author_facet | Sayaka Horiuchi Sommana Rattana Bounnack Saysanasongkham Outhevanh Kounnavongsa Shogo Kubota Julie Cayrol Kenzo Takahashi Mariko Inoue Asuka Nemoto Kazue Yamaoka |
| author_sort | Sayaka Horiuchi |
| collection | DOAJ |
| description | Abstract Background Reduction in neonatal deaths has been a major challenge globally. To prevent neonatal deaths, improvements in newborn care have been promoted worldwide. The World Health Organization Western Pacific Regional Office has been promoting the Early Essential Newborn Care (EENC), a package of specific simple and cost-effective interventions, in their region. However, mere introduction of EENC cannot reduce neonatal deaths unless quality of care is ensured. In Lao PDR, the government introduced self-managed continuous monitoring as a sustainable way to improve the quality of care described in the EENC. Methods A clustered randomized controlled trial was designed to compare the effectiveness of self-managed continuous monitoring with external supervisory visits to monitor health workers’ satisfactory EENC performance and their knowledge and skills related to the EENC in Lao PDR. Determinants of EENC performance will be measured with a structured questionnaire developed based on the Theory of Planned Behaviour, which predicts future behaviour. During self-managed continuous monitoring activities, health workers in each district hospital will conduct periodical peer reviews and feedback sessions. Fifteen district hospitals will be randomly allocated into the self-managed continuous monitoring (intervention) and the supervision (control) groups. Fifteen health workers routinely involved in maternity and newborn care including physicians, midwives and other health staff will be recruited from each hospital (effect size 0.6, intra-cluster correlation coefficient 0.06, 5% alpha error and 80% power). We will compare the change in the mean score of the determinants before and one year after randomisation between the two groups. We will also compare the retention of knowledge and skills related to the EENC between the two groups. The expected enrolment period is July 20th, 2017 to July 20th, 2018. Discussion This is the first cluster randomized trial to evaluate a self-managed continuous monitoring system for quality maintenance of newborn care in a resource-limited country. This research is conducted in collaboration with the Ministry of Health and international organizations; therefore, if effective, this intervention would be applied in larger areas of the country and the region. Trial registration This trial was registered at UMIN-CTR on 15th of June, 2017. Registration number is UMIN000027794. |
| first_indexed | 2024-04-13T03:26:57Z |
| format | Article |
| id | doaj.art-278cc4791e9047a3a242f9b4b6ac306b |
| institution | Directory Open Access Journal |
| issn | 1472-6963 |
| language | English |
| last_indexed | 2024-04-13T03:26:57Z |
| publishDate | 2018-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Health Services Research |
| spelling | doaj.art-278cc4791e9047a3a242f9b4b6ac306b2022-12-22T03:04:37ZengBMCBMC Health Services Research1472-69632018-06-0118111010.1186/s12913-018-3311-7Study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high-quality early essential newborn care in Lao PDRSayaka Horiuchi0Sommana Rattana1Bounnack Saysanasongkham2Outhevanh Kounnavongsa3Shogo Kubota4Julie Cayrol5Kenzo Takahashi6Mariko Inoue7Asuka Nemoto8Kazue Yamaoka9Teikyo University Graduate School of Public HealthDepartment of Health Care, Ministry of HealthDepartment of Health Care, Ministry of HealthMaternal and Child Health unit, World Health Organization Country Office for Lao PDRMaternal and Child Health unit, World Health Organization Country Office for Lao PDRCenter for International Child Health, Department of Paediatrics, The University of MelbourneTeikyo University Graduate School of Public HealthTeikyo University Graduate School of Public HealthTeikyo University Graduate School of Public HealthTeikyo University Graduate School of Public HealthAbstract Background Reduction in neonatal deaths has been a major challenge globally. To prevent neonatal deaths, improvements in newborn care have been promoted worldwide. The World Health Organization Western Pacific Regional Office has been promoting the Early Essential Newborn Care (EENC), a package of specific simple and cost-effective interventions, in their region. However, mere introduction of EENC cannot reduce neonatal deaths unless quality of care is ensured. In Lao PDR, the government introduced self-managed continuous monitoring as a sustainable way to improve the quality of care described in the EENC. Methods A clustered randomized controlled trial was designed to compare the effectiveness of self-managed continuous monitoring with external supervisory visits to monitor health workers’ satisfactory EENC performance and their knowledge and skills related to the EENC in Lao PDR. Determinants of EENC performance will be measured with a structured questionnaire developed based on the Theory of Planned Behaviour, which predicts future behaviour. During self-managed continuous monitoring activities, health workers in each district hospital will conduct periodical peer reviews and feedback sessions. Fifteen district hospitals will be randomly allocated into the self-managed continuous monitoring (intervention) and the supervision (control) groups. Fifteen health workers routinely involved in maternity and newborn care including physicians, midwives and other health staff will be recruited from each hospital (effect size 0.6, intra-cluster correlation coefficient 0.06, 5% alpha error and 80% power). We will compare the change in the mean score of the determinants before and one year after randomisation between the two groups. We will also compare the retention of knowledge and skills related to the EENC between the two groups. The expected enrolment period is July 20th, 2017 to July 20th, 2018. Discussion This is the first cluster randomized trial to evaluate a self-managed continuous monitoring system for quality maintenance of newborn care in a resource-limited country. This research is conducted in collaboration with the Ministry of Health and international organizations; therefore, if effective, this intervention would be applied in larger areas of the country and the region. Trial registration This trial was registered at UMIN-CTR on 15th of June, 2017. Registration number is UMIN000027794.http://link.springer.com/article/10.1186/s12913-018-3311-7Newborn careContinuous quality improvementHospital management |
| spellingShingle | Sayaka Horiuchi Sommana Rattana Bounnack Saysanasongkham Outhevanh Kounnavongsa Shogo Kubota Julie Cayrol Kenzo Takahashi Mariko Inoue Asuka Nemoto Kazue Yamaoka Study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high-quality early essential newborn care in Lao PDR BMC Health Services Research Newborn care Continuous quality improvement Hospital management |
| title | Study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high-quality early essential newborn care in Lao PDR |
| title_full | Study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high-quality early essential newborn care in Lao PDR |
| title_fullStr | Study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high-quality early essential newborn care in Lao PDR |
| title_full_unstemmed | Study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high-quality early essential newborn care in Lao PDR |
| title_short | Study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high-quality early essential newborn care in Lao PDR |
| title_sort | study protocol of a cluster randomized controlled trial to evaluate effectiveness of a system for maintaining high quality early essential newborn care in lao pdr |
| topic | Newborn care Continuous quality improvement Hospital management |
| url | http://link.springer.com/article/10.1186/s12913-018-3311-7 |
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