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

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. A cluster randomized controlled trial (CRCT) to evaluate the effect of a mobile clinical decision-making support system on maternal and neonatal mortality and morbidity will be conducted in 16 districts in the Eastern Region (ER) of Ghana. This study will comprise three components: (1) a baseline study to assess the characteristics of the health facilities and outcome measures of interest in study sites, (2) implementation of a CDMSS for 18 months and (3) a sub-study to assess the QOC of maternal and neonatal care services at baseline and at the end of the study. The study will be conducted in the ER of Ghana. The ER is the sixth largest region in terms of land area in Ghana (Fig. 1). With an estimated mid-year population of approximately 2.5 million, which is10.7% of the total national population [34], the ER is the third most populous region in Ghana. The region consists of 21 administrative districts with Koforidua in the New Juaben district as its regional capital. The ER is predominately rural in nature with pockets of urban areas in mainly the district capitals. About 40% of its inhabitants reside in 4 out of its 21 administrative districts. The most populous districts are Afram Plains Kwahu North district, West Akim district, Kwaebibirem and New Juaben district in descending order. Agricultural (mainly fish and crop farming) and mining activities are the main stay of economic activities of the region. The estimated growth rate of the ER is 2.0% [35]. 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 Each district comprises a number of subdistricts that form the administrative health subdistricts for the region. There are a total of 250 health facilities, including 31 hospitals in the region, that serve the health needs of the region’s populace [35]. Like other parts of the country, the main categories of health care facilities in the ER are – Community-based Health Planning and Services (CHPS), health centres (HC) and maternity homes and hospitals. At the primary health care level, the CHPS, HC and maternity homes provide services, including maternal and neonatal health services, to the various communities and refer cases to the hospitals. The regional neonatal mortality rate (NMR) was 29 per 1000 live births in 2008 [28]. From 2004 to 2014 the NMR of the ER was estimated as 30 per 1000 live births, showing little change over the period [27]. Presently, the ER ranks sixth in terms of high NMR in Ghana [27]. The pregnancy-related mortality ratio was also 594 per 100,000 live births in 2007 [36]. The ER was selected for this study for two reasons: its high neonatal and maternal mortality rates and because the intervention could not be implemented in the Greater Accra region where it had been designed and piloted [37]. The inclusion criteria for cluster selection for this study include the following: (1) The district is located in the ER, (2) The district has expected deliveries of at least 1100/year for the year 2014, (3) The District Health Management Team and the District Hospital Management Team agree to participate in the study and (4) Health facilities within the district conducted at least one delivery in the year 2014. The exclusion criteria for our study are: (1) The district is located outside the ER, (2) The district has expected deliveries of fewer than 1100/year for the year 2014, (3) The District Health Management Team and the Hospital Management Team do not agree to participate in the study and (4) Health facilities within the districts have not conducted at least one delivery during the year 2014. The year 2014 was selected as the baseline year as the most current data pertaining to deliveries (births) at the time of commencement of the study was for that year. A delivery (births) was a criterion for recruitment as most obstetric and neonatal complications occur around childbirth. Intervention during this period is crucial for survival and health [38]. This study is a superiority trial and has been designed and powered for neonatal mortality to contribute evidence for improved neonatal health care considering the predicted global upward trend in neonatal deaths [3] compared to maternal deaths. Two formulae were applied; the first formula was applied to estimate the required sample size in a randomized controlled trial (RCT) with binary outcome while the second formula was applied to inflate the estimated sample size for a CRCT. Neonatal mortality is the primary outcome, and is currently at approximately 30/1000 live births in the ER, Ghana. Evidence from previous studies including systematic reviews focusing on neonatal care interventions have shown a 23% to 51% reduction in neonatal mortality in settings including LIMC [39–44]. Our intervention will also address neonatal and maternal health care, hence we estimate an effect size of 30% on neonatal mortality with the use of this intervention. Intracluster correlation coefficient (ICC) for neonatal mortality in Ghana has been estimated at 0.0007256 [45]. To detect a 30% decline in neonatal mortality at a power of 80%, a significance level of 0.05 (two-tailed test), with a fixed number of eight clusters in each arm of the study, approximately 1065 patients in each of the 16 clusters will be needed. The first formula is: where m = number of patients per cluster, k = number of clusters in each arms of the study, ρ = ICC and n = is the number of patients needed to detect this effect in a RCT. The second formula is: where π 1 = is the expected proportion of the neonatal mortality at the intervention group after RCT, π∘ = is the expected proportion of the neonatal mortality at the reference group after RCT and ϴ is the variance of the two proportions at a power of 80% and significance level of 0.05. The study comprises two study arms – one intervention and one control arm. A cluster unit was defined as a district in this study. Twenty-one districts were, therefore, eligible to be part of the study. Overall, 17 clusters fulfilled the inclusion and exclusion criteria; however, the regional capital was excluded from the selection process to avoid selection bias as its regional hospital is the highest referral point in the region. Sixteen clusters were, therefore, randomized as shown in the trial flow chart (Fig. 2). Cluster randomization was preferred over individual randomization to avoid contamination both at the health professional and client levels, which may occur as a result of social interaction. Randomization was performed by an independent data analyst in order to achieve comparability and avoid selection bias. Randomization was carried out using STATA version 11.0 statistical software. Due to the nature of this intervention, masking was not feasible. 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. Activity, purple oblong; Timeline. orange oblong. One well-resourced and one poorly resourced cluster will be purposively selected from each study arm. The selection criteria will be based on the number and mix of health facilities in the district and the midwife to number of deliveries (per annum) ratio in a district. While purposive selection of these study districts does not allow generalizability of findings, application of these qualitative methods provides insight into how and why the intervention worked or not. The intervention is a clinical decision-making support system consisting of an Unstructured Supplementary Service Data (USSD)-based text messaging of standard emergency obstetric and neonatal protocols to providers on their request, based on the results of a formative study previously conducted in the Greater Accra region [37]. As a reference guideline the national Safe Motherhood Protocol (SMP) [36], an elaborate tool that provides detailed state-of-the-art guidelines for maternal and newborn care, ranging from prenatal care, through antenatal, delivery, postpartum and newborn care, was chosen. A committee of medical experts designed concise and precise protocols with respect to word limits using the USSD system and short protocols using USSD templates have been generated. Access to the USSD platform will be limited to a closed user group (intervention group) who will be provided with subscriber identity module (SIM) cards and cell phones by the research team to avoid contamination. To support the use of the USSD-based text messaging system by health care providers, health care providers in the intervention districts will receive monthly reminders via short messaging service (SMS) on the applicability of the text messaging system for clinical decision-making. Text messaging based on the USSD system was chosen as a low-cost, easily accessible and instant way of requesting needed information during routine and emergency situations by the health care provider to enhance clinical decision-making. To access the USSD platform, health care workers send a text to a specified short code and this assists in the rapid sharing of the needed information. Access to the USSD platform is free and unlimited. The USSD platform is linked to the general electronic data platform of a telecommunication company whose policy and practice assures 99.99% availability of the general electronic data platform. However, availability of phone reception to assess the network may differ according to location of health facilities.