Clinical trial NCT02331082: Integrating Pediatric Care Delivery in Rural Healthcare Systems
Official title: Integrating Pediatric Care Delivery in Rural Healthcare Systems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Mortality
Under-two Mortality
Keywords: Infant Mortality
Under-two mortality
Maternal Mortality
Implementation Research
Health Systems Strengthening
Chronic Disease Management
Commuity Health Workers
Lead sponsor: Possible
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: National Institutes of Health (NIH)
First posted: 2015-01-06
Enrollment: 7000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Under-two mortality rate
timeFrame: Five years
measure: Infant mortality rate
timeFrame: Five years
measure: Neonatal mortality rate
timeFrame: Five years
Secondary outcomes:
measure: Institutional Birth Rate
timeFrame: Five years
measure: Antenatal Care Completion Percentage
timeFrame: Five years
measure: Postpartum contraceptive prevalence rate
timeFrame: Five years
measure: Preterm delivery rate
timeFrame: Five years
measure: Low birthweight delivery rates
timeFrame: Five years
measure: Percentage of stillbirths
timeFrame: Five years
Other outcomes:
Locations:
city: Sanfebagar
country: Nepal
facility: Bayalpata Hospital
state: Achham
city: Bhimeshwor
country: Nepal
facility: Charikot Primary Health Center
state: Dolakha
Study officials:
affiliation: Possible
name: David Citrin, PhD, MPH
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Biraj Karmacharya, MBBS, MSc
role: STUDY_CHAIR
References: