Clinical Trial: Integrating Pediatric Care Delivery in Rural Healthcare Systems

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Integrating Pediatric Care Delivery in Rural Healthcare Systems

Brief Summary: 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.

Detailed Summary:

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,
Sponsor: Possible

Current Primary Outcome:

• Under-two mortality rate [ Time Frame: Five years ]
  We expect the intervention will lead to a 25% decrease in under-two mortality in the experimental arm.
• Infant mortality rate [ Time Frame: Five years ]
  We expect the intervention will lead to a 25% decrease in the infant mortality rate in the experimental arm.
• Neonatal mortality rate [ Time Frame: Five years ]
  We expect the intervention will lead to a 25% decrease in the neonatal mortality rate in the experimental arm.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Institutional Birth Rate [ Time Frame: Five years ]
  We expect the intervention will lead to a 25% increase in Institutional Birth Rate among reproductive-age women in the experimental arm.
• Antenatal Care Completion Percentage [ Time Frame: Five years ]
  We expect the intervention will lead to a 25% increase in number of pregnant women completing all 4 antenatal care visits in the experimental arm.
• Postpartum contraceptive prevalence rate [ Time Frame: Five years ]
  We expect the intervention will lead to a 20% increase in postpartum contraceptive prevalence rate among reproductive age women who have delivered in the past 2 years in the experimental arm.
• Preterm delivery rate [ Time Frame: Five years ]
  We expect the intervention will lead to 25% fewer preterm births in the experimental arm.
• Low birthweight delivery rates [ Time Frame: Five years ]
  We expect the intervention will lead to a 25% reduction in babies born with low birthweights in the experimental arm
• Percentage of stillbirths [ Time Frame: Five years ]
  We expect the intervention will lead to 25% fewer stillbirths in the experimental arm.

Original Secondary Outcome: Same as current

Information By: Possible

Dates:
Date Received: August 8, 2013
Date Started: November 2014
Date Completion: January 2019
Last Updated: February 24, 2015
Last Verified: February 2015