Background
Health worker compliance with established best-practice clinical and public health guidelines may be enhanced by customized checklists of care and clinical decision support driven by point-of-care data entry into an electronic health registry. The Palestinian public health system is currently implementing a national electronic registry (e-Registry) for maternal and child health. This trial is embedded in the national implementation efforts and aims to assess the effectiveness of the e-Registry’s interactive checklists and clinical decision support, compared with existing paper-based records, on improving the quality of care for pregnant women.
Methods
This two-arm cluster randomized controlled trial was conducted in the West Bank, Palestine, and includes 120 clusters (primary healthcare clinics) with an average annual enrollment of 60 pregnancies. The intervention tool is the e-Registry’s interactive checklists and clinical decision support implemented within the District Health Information System 2 (DHIS2) Tracker software, developed and customized for the Palestinian context. The primary outcomes reflect the processes of essential interventions, namely timely and appropriate screening and management of: 1) anemia in pregnancy; 2) hypertension in pregnancy; 3) abnormal fetal growth; 4) and diabetes mellitus in pregnancy. The composite primary health outcome encompasses five conditions representing risk for the mother or baby that could have been detected or prevented by high-quality antenatal care: Moderate or severe anemia at admission for labor; severe hypertension at admission for labor; malpresentation at delivery undetected during pregnancy; small for gestational age baby at delivery undetected during pregnancy; and large for gestational age baby at delivery. Primary analysis at the individual level, taking the design effect of the clustering into account, will be performed as intention-to-treat.
Discussion
This trial, embedded in the national implementation of the e-Registry in Palestine, allows the assessment of process and health outcomes in a large-scale pragmatic setting. Findings will inform the use of interactive checklists and clinical decision support driven by point-of-care data entry into an e-Registry as a health systems-strengthening approach.
Trial registration
ISRCTN trial registration number, ISRCTN18008445. Registered on 6 April 2017.
Mahima Venkateswaran1,2, Kjersti Mørkrid1, Buthaina Ghanem3, Eatimad Abbas3, Itimad Abuward3, Mohammad Baniode3, Ole Frithjof Norheim2,4 and J. Frederik Frøen1,2* (ID)
1 Division for Health Services, Norwegian Institute of Public Health, PB 4404,Nydalen, N-0403 Oslo, Norway.
2 Centre for Intervention Science in Maternal and Child Health (CISMAC), University of Bergen, Bergen, Norway.
3 Palestinian National Institute of Public Health, World Health Organization,P.O. Box 4284, Al-Bireh, Palestine. 4Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Venkateswaran, M., Mørkrid, K., Ghanem, B. et al. eRegQual—an electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care: study protocol for a cluster randomized trial. Trials 19, 54 (2018). https://doi.org/10.1186/s13063-017-2386-5
