title: 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.
authors.affiliation: School of Public Health, University of Ghana, Legon, PO Box LG13, Accra, Ghana. ansomaame@hotmail.com.
authors.forename: Hannah Brown
authors.identifier: 0000-0002-6575-428X
authors.initials: HB
authors.lastname: Amoakoh
authors.affiliation: Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Centre, PO Box 85500, 3508 GA, Utrecht, The Netherlands.|Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, 27 St. Andrew's Road, Parktown 2193, Johannesburg, South Africa.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Klipstein-Grobusch
authors.affiliation: School of Public Health, University of Ghana, Legon, PO Box LG13, Accra, Ghana.|Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Centre, PO Box 85500, 3508 GA, Utrecht, The Netherlands.
authors.forename: Mary
authors.initials: M
authors.lastname: Amoakoh-Coleman
authors.affiliation: School of Public Health, University of Ghana, Legon, PO Box LG13, Accra, Ghana.|Research and Development Division, Ghana Health Service, PO Box MB 190, Accra, Ghana.
authors.forename: Irene Akua
authors.initials: IA
authors.lastname: Agyepong
authors.affiliation: Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Centre, PO Box 85500, 3508 GA, Utrecht, The Netherlands.
authors.forename: Gbenga A
authors.initials: GA
authors.lastname: Kayode
authors.affiliation: Regional Health Directorate, Ghana Health Services, PO Box 175, Koforidua, Eastern Region, Ghana.
authors.forename: Charity
authors.initials: C
authors.lastname: Sarpong
authors.affiliation: Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Centre, PO Box 85500, 3508 GA, Utrecht, The Netherlands.
authors.forename: Diederick E
authors.initials: DE
authors.lastname: Grobbee
authors.affiliation: School of Public Health, University of Ghana, Legon, PO Box LG13, Accra, Ghana.|Research and Development Division, Ghana Health Service, PO Box MB 190, Accra, Ghana.
authors.forename: Evelyn K
authors.initials: EK
authors.lastname: Ansah
mesh_terms: D000066491:Clinical Decision-Making; D020000:Decision Support Systems, Clinical / Q000592:standards; D003906:Developing Countries; D005260:Female; D005869:Ghana; D006801:Humans; D007223:Infant; D000068104:Infant Health; D007226:Infant Mortality; D007231:Infant, Newborn; D000068097:Maternal Health; D008427:Maternal Health Services / Q000592:standards; D008428:Maternal Mortality; D017410:Practice Guidelines as Topic; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D012107:Research Design; D012307:Risk Factors; D017216:Telemedicine / Q000379:methods* / Q000592:standards; D060145:Text Messaging; D013997:Time Factors
keywords: Clinical decision-making; Ghana; Maternal; Mobile health (mHealth); Neonatal; Text messaging