Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 4, 2021
Date Accepted: Apr 13, 2021
eRegMat – an eRegistry for improved quality of antenatal care in rural Bangladesh: study protocol for a cluster-randomized controlled trial
ABSTRACT
Background:
Digital health interventions (DHIs) can alleviate several barriers to achieving better maternal and child health. The World Health Organization’s guideline recommendations for DHIs emphasize the need to integrate multiple DHIs to maximize impact. The complex health system of Bangladesh provides a unique setting to evaluate and understand the role of an electronic registry (eRegistry) for antenatal care, with multiple integrated DHIs for health systems strengthening, in improving quality and utilization of the public health care system.
Objective:
We have designed a cluster randomized controlled trial (CRCT) in the community and in frontline health facilities to compare an eRegistry with integrated DHIs, versus a simple electronic data entry tool.
Methods:
The eRegMat CRCT is being conducted in the Matlab North and Matlab South sub-districts in Chandpur District, Bangladesh, where health facilities are currently using the eRegistry for digital tracking of the health status of pregnant women longitudinally. The intervention arm receives three superimposed data-driven DHIs: i) health worker clinical decision support, ii) health worker feedback dashboards with action items, and iii) targeted client communication to pregnant women. The primary outcomes are appropriate screening and management of hypertension during pregnancy and timely antenatal care attendance. The secondary outcomes are morbidity and mortality in the perinatal period, as well as timely first antenatal care visit, successful referrals for anemia, diabetes, or hypertension during pregnancy, and facility delivery.
Results:
The eRegistry and the DHIs were co-designed with the end users between 2016 and 2018. The eRegistry was implemented in the study area in July 2018. Recruitment for the trial started in October 2018 and ended in June 2020, followed by an 8 month follow-up period until January 2021. The CRCT results will be available for publication in April 2021.
Conclusions:
This CRCT allows for simultaneous assessment of multiple integrated DHIs for health systems strengthening and aims to provide evidence for implementation. The study design and outcomes are geared towards informing the living review process of the guidelines for implementation of DHIs. Clinical Trial: ISRCTN69491836, ISRTCN. Registered October 26, 2018. Updated June 30, 2020.
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