Integrating Pediatric Care Delivery in Rural Healthcare Systems
1 other identifier
interventional
7,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2013
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedDecember 6, 2017
December 1, 2017
4.9 years
August 8, 2013
December 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Under-two mortality rate
We expect the intervention will lead to a 25% decrease in under-two mortality in the experimental arm.
Five years
Infant mortality rate
We expect the intervention will lead to a 25% decrease in the infant mortality rate in the experimental arm.
Five years
Neonatal mortality rate
We expect the intervention will lead to a 25% decrease in the neonatal mortality rate in the experimental arm.
Five years
Secondary Outcomes (6)
Institutional Birth Rate
Five years
Antenatal Care Completion Percentage
Five years
Postpartum contraceptive prevalence rate
Five years
Preterm delivery rate
Five years
Low birthweight delivery rates
Five years
- +1 more secondary outcomes
Study Arms (2)
Control
ACTIVE COMPARATORExisting healthcare system
Health System Improvement
EXPERIMENTALStructured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing
Interventions
For structured quality improvement, trained healthcare providers (primarily doctors from referral hospital) will serve as mentors to mid-level providers. The mentors will facilitate on-site trainings of primary care with mid-level providers at the district hospital. Mentors will also travel monthly to the healthcare facilities themselves to provide training both in the direct context of clinical care and to provide feedback based upon surveillance and monitoring data. The focus will be on the techniques from the Institute for Healthcare Improvement's Model for Improvement, including Plan-Do-Study-Act cycles, run charts, and root cause analyses. Finally, they will work with the clinical healthcare staff to identify resource needs from the local government for maintenance, water, electricity, and supplies. These resource needs will be addressed through an integrated supply chain management system across the tiers of the healthcare system.
Senior physicians trained in mentorship of non-physician mid-level providers will provide decision support for mid-level providers in the current district healthcare system with specific protocols for target conditions. We will add the following elements: focus on mid-level, non-physician providers as the primary clinicians within the intervention; intensive Community Health Worker (CHW) outreach for detection, screening, follow-up of patients, and encouragement of patient self-care and behavior change; and focused effort on the seamless care coordination of patients across the tiers of the system. Through trainings of CHWs, much of patient self-management comes in the form of home visits that reinforce clinic and hospital counseling, including risk management and prevention. CHWs will be trained in the counseling of each target condition, with counseling largely occurring in the patients' homes, where much of the challenges of chronic disease management and behavior change lie.
Clinical information systems. We are developing a system for tracking patients that integrates across each of the tiers using an electronic medical record. This is a key technology in supporting each of the above delivery system design elements.
As a component of our comprehensive healthcare systems strengthening intervention, we are installing solar panels at community-level clinics to ensure continuous electrical supply for medical devices and technology.
As part of our healthcare systems strengthening intervention, we have established a performance-based financing agreement with the Government of Nepal that conditionally funds healthcare delivery based on population-level health outcomes and quality healthcare service delivery. In this arrangement, the Government serves as a regulator of healthcare delivery rather than a primary provider of healthcare services.
This is the current rural, district-level public sector healthcare infrastructure of rural Nepal that is not strengthened during the study.
Eligibility Criteria
You may qualify if:
- Female
- Reproductive age, 15-49 years
- Resides within 14 village clusters that comprise experimental/control arms
You may not qualify if:
- n/a
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Possiblelead
- Brigham and Women's Hospitalcollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (2)
Bayalpata Hospital
Sanfebagar, Achham, Nepal
Charikot Primary Health Center
Bhimeshwor, Dolakha, Nepal
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Citrin, PhD, MPH
Possible
- STUDY CHAIR
Biraj Karmacharya, MBBS, MSc
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2013
First Posted
January 6, 2015
Study Start
November 1, 2014
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
December 6, 2017
Record last verified: 2017-12