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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Mahima Venkateswaran, Kjersti Mørkrid, Buthaina Ghanem, Eatimad Abbas, Itimad Abuward, Mohammad Baniode, Ole Frithjof Norheim, J. Frederik Frøen
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:https://​doi.​org/​10.​1186/​s13063-017-2386-5) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: Definitions and indicators for assessment of process/ adherence primary outcomes and secondary outcomes. (DOCX 19 kb)
13063_2017_2386_MOESM1_ESM.docx
Additional file 2: Management algorithms for outcome-related conditions during antenatal care in the public healthcare system in Palestine. (DOCX 189 kb)
13063_2017_2386_MOESM2_ESM.docx
Additional file 3: List of participating clinics by district and allocation. (DOCX 19 kb)
13063_2017_2386_MOESM3_ESM.docx
Additional file 4: Standard Protocol Items: Recommendations for Intervention trials (SPIRIT) 2013 checklist: recommended items to address in a clinical trial protocol and related documents. (DOCX 51 kb)
13063_2017_2386_MOESM4_ESM.docx
Literatur
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