Effectiveness of Checklist-Based Box System Interventions (CBBSI) versus routine care on improving utilization of maternal health services in Northwest Ethiopia: study protocol for a cluster randomized controlled trial

BACKGROUND: Maternal mortality is still high in Ethiopia. Antenatal care, the use of skilled delivery and postnatal care are key maternal health care services that can significantly reduce maternal mortality. However, in low- and middle-income countries, including Ethiopia, utilization of these key services is limited, and preventive, promotive and curative services are not provided as per the recommendations. The aim of this study is to examine the effectiveness of checklist-based box system interventions on improving maternal health service utilization. METHODS: A community-level, cluster-randomized controlled trial will be conducted to compare the effectiveness of checklist-based box system interventions over the routine standard of care as a control arm. The intervention will use a health-extension program provided by health extension workers and midwives using a special type of health education scheduling box placed at health posts and a service utilization monitoring box placed at health centers. For this, 1200 pregnant mothers at below 16 weeks of gestation will be recruited from 30 clusters. Suspected pregnant mothers will be identified through a community survey and linked to the nearby health center. With effective communication between health centers and health posts, dropout-tracing mechanisms are implemented to help mothers resume service utilization. Data will be collected using an open data kit and analyzed using STATA version 13.0. Data will be analyzed by the intention-to-treat analysis. Risk ratios will be computed at the cluster level and the summary will be compared using t tests. Outcomes between intervention and control groups will be compared with random effects logistic regression models. Achieving four antenatal care visits, health facility delivery, and postnatal care visits at 6 weeks after delivery were treated as primary outcomes for this study. DISCUSSION: We expect that the study will generate evidence on the effectiveness of checklist-based box system interventions on improving utilization of maternal health care service that will produce inputs for related policies in Ethiopia. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03891030. Retrospectively registered on 26 March 2019.