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

BackgroundReduction 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.MethodsA 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.DiscussionThis 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 registrationThis trial was registered at UMIN-CTR on 15th of June, 2017. Registration number is UMIN000027794.Electronic supplementary materialThe online version of this article (10.1186/s12913-018-3311-7) contains supplementary material, which is available to authorized users.

Human Resources for Health-Related Challenges to Ensuring Quality Newborn Care in Low- and Middle-Income Countries: A Scoping Review

“…Poor supervision is cited as a problem leading to poor HW retention, low morale and motivation, and poor-quality care provision. 35 , 44 , 53 , 59 Horiuchi et al 59 noted that although external supervisory visits are a common approach to promote behavioral change among newborn HWs, reinforce skills, and maintain quality of care, these visits are often not feasible in resource-limited settings, such as Lao PDR, due to both high cost and human resource demands. The authors note that there is minimal capacity to implement routine supervision; however, when supervision visits occur, problems identified often remain unsolved.…”

“…The authors note that there is minimal capacity to implement routine supervision; however, when supervision visits occur, problems identified often remain unsolved. 59 Similarly, maternal and newborn HWs interviewed in Tanzania reported supervision and performance appraisal to be punitive and to lack confidentiality. 53…”

“…17,67 Planned studies to evaluate self-managed continuous monitoring by peer reviews and feedback sessions as a more sustainable way to improve quality of care may prove an alternative to current supervision approaches. 59 Quality care provision is dependent on HW motivation-a critical driver for HWs' willingness to maintain their professional competence, apply themselves to their jobs, and continue in the workforce. 67,[82][83][84][85] Low levels of HW morale and high levels of stress and burnout have been identified in the literature as an often-neglected problem (theme 8) and have been widely documented among NICU nurses, nurses, and midwives.…”

“… 17 , 67 Planned studies to evaluate self-managed continuous monitoring by peer reviews and feedback sessions as a more sustainable way to improve quality of care may prove an alternative to current supervision approaches. 59 …”

Effectiveness of self-managed continuous monitoring for maintaining high-quality early essential newborn care compared to supervision visit in Lao PDR: a cluster randomised controlled trial

“…Registration number is UMIN000027794. Details of the study methods are described elsewhere [ 13 ].…”