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Integrating Pediatric Care Delivery in Rural Healthcare Systems

P

Possible

Status

Unknown

Conditions

Infant Mortality
Under-two Mortality

Treatments

Other: Existing healthcare system
Behavioral: Performance-based financing
Device: Solar-powered electrical supply
Device: Integrated Electronic Medical Record
Other: Structured Quality Improvement
Other: Chronic Care Model

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02331082
hssnyaya

Details and patient eligibility

About

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.

Full 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.

Enrollment

7,000 estimated patients

Sex

Female

Ages

15 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • n/a

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7,000 participants in 2 patient groups

Control
Active Comparator group
Description:
Existing healthcare system
Treatment:
Other: Existing healthcare system
Health System Improvement
Experimental group
Description:
Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing
Treatment:
Other: Chronic Care Model
Device: Integrated Electronic Medical Record
Other: Structured Quality Improvement
Device: Solar-powered electrical supply
Behavioral: Performance-based financing

Trial contacts and locations

2

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Central trial contact

Duncan Maru, MD, PhD; Scott Halliday, MS

Data sourced from clinicaltrials.gov

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