Infant Mortality Clinical Trial
Official title:
Integrating Pediatric Care Delivery in Rural Healthcare Systems
Globally, over seven million children under the age of five die each year, although a suite of interventions—safe delivery care, neonatal care and resuscitation, and management of childhood diarrhea, malnutrition, and pneumonia—can prevent many of these deaths when implemented within functioning health systems. This study will include a quasi experimental, stepped wedge, cluster-controlled trial of a mobile health care coordination and quality improvement intervention designed to facilitate comprehensive health systems strengthening. It will do this through training and equipping community-level health care clinics to manage chronic diseases through use of the Chronic Care Model, structured quality improvement sessions to promote clinical mentorship, and use of an integrated electronic medical record to provide real-time data for disease surveillance. The investigators hypothesize that improving upon the health system in these ways will lead to a 25% reduction in under-two mortality through improved services for the citizens of Achham, Nepal.
Introduction: A central challenge in the delivery of evidence-based interventions to promote
under-five child survival is the coordination of care across the multiple tiers of the health
system, from frontline health workers, to primary care clinics, to district hospitals, to
specialty providers. Additionally, children who survive or avoid once-fatal diseases such as
congenital and rheumatic heart diseases, prematurity, neurodevelopmental conditions, and
disabilities sustained from traumatic injuries, are increasingly living well into
adolescence, young adulthood, and beyond. Healthcare delivery systems in resource-limited
settings, however, are ill-equipped to manage such patients' care. Mobile technologies,
coupled with effective management strategies, may enhance implementation and coordination of
evidence-based interventions, but few controlled trials exist to validate this. Particularly
lacking are strategies that incorporate mobile technologies in an integrated manner across
the health system.
Intervention: We have developed a mobile health care coordination and quality improvement
intervention within two rural district healthcare systems in Nepal, where the child mortality
rate is an estimated 82 per 1,000, and coordination of child health care is poor. Firstly,
the intervention aims to increase the timely engagement in acute care for children under the
age of five to receive evidence-based World Health Organization protocols aimed at reducing
child mortality—Integrated Management of Pregnancy and Childbirth, Integrated Management of
Childhood Illness, Integrated Management of Emergency and Essential Surgical Care, and
Community-based Management of Severe Acute Malnutrition. Secondly, the intervention aims to
implement a Chronic Care Model for pediatric patients under the age of twenty suffering from
a chronic disease (congenital and rheumatic heart disease, diabetes, depression, epilepsy,
asthma, musculoskeletal and neurodevelopmental disabilities, and pre- and post-surgical
conditions).
Analysis: We will conduct a quasi-experimental, stepped-wedge, cluster-controlled trial. The
primary outcome of this trial will be under-two mortality. We hypothesize a 25% reduction in
under-two mortality rate during the intervention periods, relative to the control period. We
hypothesize a 50% improvement in follow-up rates, a 30% improvement in global symptoms score,
a 20% reduction in disability score, and a 20% reduction in inpatient days in hospital. We
will use both quantitative and qualitative methods to assess the scalability of the
intervention in terms of logistics, human resources, costs, and utilization.
Impact: Rigorous evaluations of systems-level child healthcare interventions are needed to
drive global healthcare policies and their implementation. The trial proposed here will
inform the potential impact and scalability of health systems strengthening interventions.
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