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

Abstract

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 public health system of Palestine is currently implementing a national electronic registry (eRegistry) for maternal and child health. This trial is embedded in the national implementation and aims to assess the effectiveness of the eRegistry's interactive checklists and clinical decision support, compared with the existing paper based records, on improving the quality of care for pregnant women.

Methods: This two-arm cluster randomized controlled trial is 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 eRegistry'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 eRegistry 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 eRegistry as a health systems-strengthening approach.

Trial registration: ISRCTN trial registration number, ISRCTN18008445 . Registered on 6 April 2017.

Keywords: Antenatal care; Clinical decision support; Electronic registry; Health surveillance; Health systems; Interactive checklists; Maternal and newborn health; Quality of care; eHealth; eRegistries.

Fig. 1

Flow diagram showing eligibility screening and recruitment of primary healthcare clinics (PHC). *We have grouped 25 small clinics in terms of annual number of newly enrolled preganancies (cluster size) to form 11 contiguous pairs and 1 contguous group of three clinics. The remaining PHC (n = 108) are individual clusters of their own, resulting in 120 clusters in total. MCH Maternal and Child Health, MoH Ministry of Health

Fig. 2

Intervention: illustration of interactive checklists. The top bar shows computed age, risk status, expected date of delivery (EDD), management status, gestational age at visit, and obstetric score

Fig. 3

Intervention: illustration of clinical decision support. Clinical decision support shows chronic hypertension on the right panel in response to high blood pressure values at a gestational age of 12 weeks

Fig. 4

Intervention: illustration of clinical management reminders. The bottom panel shows routine management reminders according to the antenatal care visit (folic acid supplementation, first routine ultrasound) and management support for the identified risk condition (referral to high-risk clinic and specialist)

Fig. 5

SPIRIT figure. Schedule of enrolment, intervention, and assessments. eRegistry electronic registry