Integrating Pediatric Care Delivery in Rural Healthcare Systems

Not Applicable

• Conditions: Infant Mortality; Under-two Mortality
• Interventions: Other: Existing healthcare system; Other: Structured Quality Improvement; Other: Chronic Care Model; Device: Integrated Electronic Medical Record; Device: Solar-powered electrical supply; Behavioral: Performance-based financing

• Registration Number: NCT02331082
• Lead Sponsor: Possible

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 Description

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.

Study Timeline

• Study First Submitted: 2013-08-08
• Study Start: 2014-11-01
• Study First Submitted QC: 2014-12-31
• Study First Posted: 2015-01-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 7000

Inclusion Criteria

• Female
• Reproductive age, 15-49 years
• Resides within 14 village clusters that comprise experimental/control arms

Exclusion Criteria

• n/a

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Existing healthcare system	Existing healthcare system
Health System Improvement	Integrated Electronic Medical Record	Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing
Health System Improvement	Structured Quality Improvement	Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing
Health System Improvement	Solar-powered electrical supply	Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing
Health System Improvement	Chronic Care Model	Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing
Health System Improvement	Performance-based financing	Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of stillbirths	Five years	We expect the intervention will lead to 25% fewer stillbirths in the experimental arm.
Postpartum contraceptive prevalence rate	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.
Institutional Birth Rate	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	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.
Preterm delivery rate	Five years	We expect the intervention will lead to 25% fewer preterm births in the experimental arm.
Low birthweight delivery rates	Five years	We expect the intervention will lead to a 25% reduction in babies born with low birthweights in the experimental arm

Trial Locations

Locations (2)

Bayalpata Hospital; 🇳🇵 Sanfebagar, Achham, Nepal

Charikot Primary Health Center; 🇳🇵 Bhimeshwor, Dolakha, Nepal