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Randomized Controlled Trial
. 2017 Apr 4;18(1):157.
doi: 10.1186/s13063-017-1897-4.

The effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial

Hannah Brown Amoakoh  1 , Kerstin Klipstein-Grobusch  2   3 , Mary Amoakoh-Coleman  4   2 , Irene Akua Agyepong  4   5 , Gbenga A Kayode  2 , Charity Sarpong  6 , Diederick E Grobbee  2 , Evelyn K Ansah  4   5
Affiliations
Randomized Controlled Trial

The effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial

Hannah Brown Amoakoh et al. Trials. .

Abstract

Background: Mobile health (mHealth) presents one of the potential solutions to maximize health worker impact and efficiency in an effort to reach the Sustainable Development Goals 3.1 and 3.2, particularly in sub-Saharan African countries. Poor-quality clinical decision-making is known to be associated with poor pregnancy and birth outcomes. This study aims to assess the effect of a clinical decision-making support system (CDMSS) directed at frontline health care providers on neonatal and maternal health outcomes.

Methods/design: A cluster randomized controlled trial will be conducted in 16 eligible districts (clusters) in the Eastern Region of Ghana to assess the effect of an mHealth CDMSS for maternal and neonatal health care services on maternal and neonatal outcomes. The CDMSS intervention consists of an Unstructured Supplementary Service Data (USSD)-based text messaging of standard emergency obstetric and neonatal protocols to providers on their request. The primary outcome of the intervention is the incidence of institutional neonatal mortality. Outcomes will be assessed through an analysis of data on maternal and neonatal morbidity and mortality extracted from the District Health Information Management System-2 (DHIMS-2) and health facility-based records. The quality of maternal and neonatal health care will be assessed in two purposively selected clusters from each study arm.

Discussion: In this trial the effect of a mobile CDMSS on institutional maternal and neonatal health outcomes will be evaluated to generate evidence-based recommendations for the use of mobile CDMSS in Ghana and other West African countries.

Trial registration: ClinicalTrials.gov, identifier: NCT02468310 . Registered on 7 September 2015; Pan African Clinical Trials Registry, identifier: PACTR20151200109073 . Registered on 9 December 2015 retrospectively from trial start date.

Keywords: Clinical decision-making; Ghana; Maternal; Mobile health (mHealth); Neonatal; Text messaging.

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Figures

Fig. 1
Fig. 1
Map of districts in the Eastern Region of Ghana. The districts were defined as cluster units. Sixteen districts fulfilled our inclusion/exclusion criteria. The regional capital, New Juaben Municipal, was excluded from the sampling to avoid selection bias as its regional hospital serves as the highest referral point in the region
Fig. 2
Fig. 2
Trial flow chart showing cluster selection, assignment and timelines of the cluster randomized controlled trial (CRCT). Clusters that fulfilled the inclusion and exclusion criteria were randomized into eight control and eight intervention clusters. The CRCT started in August 2015 and ends in January 2017. formula image Activity, purple oblong; Timeline. formula image orange oblong.
Fig. 3
Fig. 3
Schedule of enrollment, intervention allocation and assessment using Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure for study protocols
Fig. 4
Fig. 4
Conceptual framework for evaluating the effect of a clinical decision-making support system (CDMSS) on maternal and neonatal mortality and morbidity in Ghana (2016). The intervention includes training of frontline health workers to utilize the unstructured supplementary service data. The impact of the intervention will be assessed by measuring maternal and neonatal deaths
See this image and copyright information in PMC

References

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