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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.

ABSTRACT: 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.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.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.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.

SUBMITTER: Amoakoh HB

PROVIDER: S-EPMC5379695 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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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.

Amoakoh Hannah Brown HB Klipstein-Grobusch Kerstin K Amoakoh-Coleman Mary M Agyepong Irene Akua IA Kayode Gbenga A GA Sarpong Charity C Grobbee Diederick E DE Ansah Evelyn K EK

Trials 20170404 1

<h4>Background</h4>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 ...[more]

PMID: 28372580

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Project description:BackgroundMHealth interventions promise to bridge gaps in clinical care but documentation of their effectiveness is limited. We evaluated the utilization and effect of an mhealth clinical decision-making support intervention that aimed to improve neonatal mortality in Ghana by providing access to emergency neonatal protocols for frontline health workers.MethodsIn the Eastern Region of Ghana, sixteen districts were randomized into two study arms (8 intervention and 8 control clusters) in a cluster-randomized controlled trial. Institutional neonatal mortality data were extracted from the District Health Information System-2 during an 18-month intervention period. We performed an intention-to-treat analysis and estimated the effect of the intervention on institutional neonatal mortality (primary outcome measure) using grouped binomial logistic regression with a random intercept per cluster. This trial is registered at ClinicalTrials.gov (NCT02468310 ) and Pan African Clinical Trials Registry (PACTR20151200109073).FindingsThere were 65,831 institutional deliveries and 348 institutional neonatal deaths during the study period. Overall, 47 ∙ 3% of deliveries and 56 ∙ 9% of neonatal deaths occurred in the intervention arm. During the intervention period, neonatal deaths increased from 4 ∙ 5 to 6 ∙ 4 deaths and, from 3 ∙ 9 to 4 ∙ 3 deaths per 1000 deliveries in the intervention arm and control arm respectively. The odds of neonatal death was 2⋅09 (95% CI (1 ∙ 00;4 ∙ 38); p = 0 ∙ 051) times higher in the intervention arm compared to the control arm (adjusted odds ratio). The correlation between the number of protocol requests and the number of deliveries per intervention cluster was 0 ∙ 71 (p = 0 ∙ 05).InterpretationThe higher risk of institutional neonatal death observed in intervention clusters may be due to problems with birth and death registration, unmeasured and unadjusted confounding, and unintended use of the intervention. The findings underpin the need for careful and rigorous evaluation of mHealth intervention implementation and effects.FundingNetherlands Foundation for Scientific Research - WOTRO, Science for Global Development; Utrecht University.

Project description:BACKGROUND:Developing and maintaining resilient health systems in low-resource settings like Ghana requires innovative approaches that adapt technology to context to improve health outcomes. One such innovation was a mobile health (mHealth) clinical decision-making support system (mCDMSS) that utilized text messaging (short message service, SMS) of standard emergency maternal and neonatal protocols via an unstructured supplementary service data (USSD) on request of the health care providers. This mCDMSS was implemented in a cluster randomized controlled trial (CRCT) in the Eastern Region of Ghana. OBJECTIVE:This study aimed to analyze the pattern of requests made to the USSD by health workers (HWs). We assessed the relationship between requests made to the USSD and types of maternal and neonatal morbidities reported in health facilities (HFs). METHODS:For clusters in the intervention arm of the CRCT, all requests to the USSD during the 18-month intervention period were extracted from a remote server, and maternal and neonatal health outcomes of interest were obtained from the District Health Information System of Ghana. Chi-square and Fisher exact tests were used to compare the proportion and type of requests made to the USSD by cluster, facility type, and location; whether phones accessing the intervention were shared facility phones or individual-use phones (type-of-phone); or whether protocols were accessed during the day or at night (time-of-day). Trends in requests made were analyzed over 3 6-month periods. The relationship between requests made and the number of cases reported in HFs was assessed using Spearman correlation. RESULTS:In total, 5329 requests from 72 (97%) participating HFs were made to the intervention. The average number of requests made per cluster was 667. Requests declined from the first to the third 6-month period (44.96% [2396/5329], 39.82% [2122/5329], and 15.22% [811/5329], respectively). Maternal conditions accounted for the majority of requests made (66.35% [3536/5329]). The most frequently accessed maternal conditions were postpartum hemorrhage (25.23% [892/3536]), other conditions (17.82% [630/3536]), and hypertension (16.49% [583/3536]), whereas the most frequently accessed neonatal conditions were prematurity (20.08% [360/1793]), sepsis (15.45% [277/1793]), and resuscitation (13.78% [247/1793]). Requests made to the mCDMSS varied significantly by cluster, type of request (maternal or neonatal), facility type and its location, type-of-phone, and time-of-day at 6-month interval (P<.001 for each variable). Trends in maternal and neonatal requests showed varying significance over each 6-month interval. Only asphyxia and sepsis cases showed significant correlations with the number of requests made (r=0.44 and r=0.79; P<.001 and P=.03, respectively). CONCLUSIONS:There were variations in the pattern of requests made to the mCDMSS over time. Detailed information regarding the use of the mCDMSS provides insight into the information needs of HWs for decision-making and an opportunity to focus support for HW training and ultimately improved maternal and neonatal health.

Project description:BackgroundThis study assessed health workers' adherence to neonatal health protocols before and during the implementation of a mobile health (mHealth) clinical decision-making support system (mCDMSS) that sought to bridge access to neonatal health protocol gap in a low-resource setting.MethodsWe performed a cross-sectional document review within two purposively selected clusters (one poorly-resourced and one well-resourced), from each arm of a cluster-randomized trial at two different time points: before and during the trial. The total trial consisted of 16 clusters randomized into 8 intervention and 8 control clusters to assess the impact of an mCDMSS on neonatal mortality in Ghana. We evaluated health workers' adherence (expressed as percentages) to birth asphyxia, neonatal jaundice and cord sepsis protocols by reviewing medical records of neonatal in-patients using a checklist. Differences in adherence to neonatal health protocols within and between the study arms were assessed using Wilcoxon rank-sum and permutation tests for each morbidity type. In addition, we tracked concurrent neonatal health improvement activities in the clusters during the 18-month intervention period.ResultsIn the intervention arm, mean adherence was 35.2% (SD = 5.8%) and 43.6% (SD = 27.5%) for asphyxia; 25.0% (SD = 14.8%) and 39.3% (SD = 27.7%) for jaundice; 52.0% (SD = 11.0%) and 75.0% (SD = 21.2%) for cord sepsis protocols in the pre-intervention and intervention periods respectively. In the control arm, mean adherence was 52.9% (SD = 16.4%) and 74.5% (SD = 14.7%) for asphyxia; 45.1% (SD = 12.8%) and 64.6% (SD = 8.2%) for jaundice; 53.8% (SD = 16.0%) and 60.8% (SD = 11.7%) for cord sepsis protocols in the pre-intervention and intervention periods respectively. We observed nonsignificant improvement in protocol adherence in the intervention clusters but significant improvement in protocol adherence in the control clusters. There were 2 concurrent neonatal health improvement activities in the intervention clusters and over 12 in the control clusters during the intervention period.ConclusionWhether mHealth interventions can improve adherence to neonatal health protocols in low-resource settings cannot be ascertained by this study. Neonatal health improvement activities are however likely to improve protocol adherence. Future mHealth evaluations of protocol adherence must account for other concurrent interventions in study contexts.

Project description:ObjectivesTo explore the "how" and "why" of care decision making by frontline providers of maternal and newborn services in the Greater Accra region of Ghana and determine appropriate interventions needed to support its quality and related maternal and neonatal outcomes.MethodsA cross sectional and descriptive mixed method study involving a desk review of maternal and newborn care protocols and guidelines availability, focus group discussions and administration of a structured questionnaire and observational checklist to frontline providers of maternal and newborn care.ResultsTacit knowledge or 'mind lines' was an important primary approach to care decision making. When available, protocols and guidelines were used as decision making aids, especially when they were simple handy tools and in situations where providers were not sure what their next step in management had to be. Expert opinion and peer consultation were also used through face to face discussions, phone calls, text messages, and occasional emails depending on the urgency and communication medium access. Health system constraints such as availability of staff, essential medicines, supplies and equipment; management issues (including leadership and interpersonal relations among staff), and barriers to referral were important influences in decision making. Frontline health providers welcomed the idea of interventions to support clinical decision making and made several proposals towards the development of such an intervention. They felt such an intervention ought to be multi-faceted to impact the multiple influences simultaneously. Effective interventions would also need to address immediate challenges as well as more long-term challenges influencing decision-making.ConclusionSupporting frontline worker clinical decision making for maternal and newborn services is an important but neglected aspect of improved quality of care towards attainment of MDG 4 & 5. A multi-faceted intervention is probably the best way to make a difference given the multiple inter-related issues.

Project description:BackgroundGhana did not meet the Millennium Development Goal 4 of reducing child mortality by two-thirds and may not meet SDG (2030). There is a need to direct scarce resources to mitigate the impact of the most important risk factors influencing high neonatal deaths. This study applied both spatial and non-spatial regression models to explore the differential impact of environmental, maternal, and child associated risk factors on neonatal deaths in Ghana.MethodsThe study relied on data from the Ghana Demographic and Health Surveys (GDHS) and the Ghana Maternal Health Survey (GMHS) conducted between 1998 and 2017 among 49,908 women of reproductive age and 31,367 children under five (GDHS-1998 = 3298, GDHS-2003 = 3844, GDHS-2008 = 2992, GDHS-2014 = 5884, GMHS-2017 = 15,349). Spatial Autoregressive Models that account for spatial autocorrelation in the data at the cluster-level and non-spatial statistical models with appropriate sampling weight adjustment were used to study factors associated with neonatal deaths, and a p-value less than 0.05 was considered statistically significant.ResultsPopulation density, multiple births, smaller household sizes, high parity, and low birth weight significantly increased the risk of neonatal deaths over the years. Among mothers who had multiple births, the risk of having neonatal deaths was approximately four times as high as the risk of neonatal deaths among mothers who had only single birth [aRR = 3.42, 95% CI: 1.63-7.17, p < 0.05]. Neonates who were perceived by their mothers to be small were at a higher risk of neonatal death compared to very large neonates [aRR = 2.08, 95% CI: 1.19-3.63, p < 0.05]. A unit increase in the number of children born to a woman of reproductive age was associated with a 49% increased risk in neonatal deaths [aRR = 1.49, 95% CI: 1.30-1.69, p < 0.05].ConclusionNeonatal mortality in Ghana remains relatively high, and the factors that predisposed children to neonatal death were birth size that were perceived to be small, low birth weight, higher parity, and multiple births. Improving pregnant women's nutritional patterns and providing special support to women who have multiple deliveries will reduce neonatal mortality in Ghana.

Dataset Information

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.

Publications

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.

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