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Integrating Pediatric Care Delivery in Rural Healthcare Systems

Primary Purpose

Infant Mortality, Under-two Mortality

Status
Unknown status
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Structured Quality Improvement
Chronic Care Model
Integrated Electronic Medical Record
Solar-powered electrical supply
Performance-based financing
Existing healthcare system
Sponsored by
Possible
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infant Mortality focused on measuring Infant Mortality, Under-two mortality, Maternal Mortality, Implementation Research, Health Systems Strengthening, Chronic Disease Management, Commuity Health Workers

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • n/a

Sites / Locations

  • Bayalpata HospitalRecruiting
  • Charikot Primary Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Health System Improvement

Arm Description

Existing healthcare system

Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Institutional Birth Rate
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
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
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
We expect the intervention will lead to 25% fewer preterm births in the experimental arm.
Low birthweight delivery rates
We expect the intervention will lead to a 25% reduction in babies born with low birthweights in the experimental arm
Percentage of stillbirths
We expect the intervention will lead to 25% fewer stillbirths in the experimental arm.

Full Information

First Posted
August 8, 2013
Last Updated
December 4, 2017
Sponsor
Possible
Collaborators
Brigham and Women's Hospital, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02331082
Brief Title
Integrating Pediatric Care Delivery in Rural Healthcare Systems
Official Title
Integrating Pediatric Care Delivery in Rural Healthcare Systems
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Possible
Collaborators
Brigham and Women's Hospital, National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Mortality, Under-two Mortality
Keywords
Infant Mortality, Under-two mortality, Maternal Mortality, Implementation Research, Health Systems Strengthening, Chronic Disease Management, Commuity Health Workers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Existing healthcare system
Arm Title
Health System Improvement
Arm Type
Experimental
Arm Description
Structured Quality Improvement Chronic Care Model Integrated Electronic Medical Record Solar-powered electrical supply Performance-based financing
Intervention Type
Other
Intervention Name(s)
Structured Quality Improvement
Other Intervention Name(s)
Clincal Mentorship, Supply Chain Management
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Chronic Care Model
Other Intervention Name(s)
Task-Shifting, Healthcare Systems Strengthening
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Integrated Electronic Medical Record
Other Intervention Name(s)
Electronic Medical Record
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Solar-powered electrical supply
Other Intervention Name(s)
Solar Panel
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Performance-based financing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Existing healthcare system
Other Intervention Name(s)
Control
Intervention Description
This is the current rural, district-level public sector healthcare infrastructure of rural Nepal that is not strengthened during the study.
Primary Outcome Measure Information:
Title
Under-two mortality rate
Description
We expect the intervention will lead to a 25% decrease in under-two mortality in the experimental arm.
Time Frame
Five years
Title
Infant mortality rate
Description
We expect the intervention will lead to a 25% decrease in the infant mortality rate in the experimental arm.
Time Frame
Five years
Title
Neonatal mortality rate
Description
We expect the intervention will lead to a 25% decrease in the neonatal mortality rate in the experimental arm.
Time Frame
Five years
Secondary Outcome Measure Information:
Title
Institutional Birth Rate
Description
We expect the intervention will lead to a 25% increase in Institutional Birth Rate among reproductive-age women in the experimental arm.
Time Frame
Five years
Title
Antenatal Care Completion Percentage
Description
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.
Time Frame
Five years
Title
Postpartum contraceptive prevalence rate
Description
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.
Time Frame
Five years
Title
Preterm delivery rate
Description
We expect the intervention will lead to 25% fewer preterm births in the experimental arm.
Time Frame
Five years
Title
Low birthweight delivery rates
Description
We expect the intervention will lead to a 25% reduction in babies born with low birthweights in the experimental arm
Time Frame
Five years
Title
Percentage of stillbirths
Description
We expect the intervention will lead to 25% fewer stillbirths in the experimental arm.
Time Frame
Five years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Reproductive age, 15-49 years Resides within 14 village clusters that comprise experimental/control arms Exclusion Criteria: n/a
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duncan Maru, MD, PhD
Phone
1-617-553-4256
Email
duncan@possiblehealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Halliday, MS
Phone
1-530-219-8807
Email
scott@possiblehealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Citrin, PhD, MPH
Organizational Affiliation
Possible
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Biraj Karmacharya, MBBS, MSc
Organizational Affiliation
University of Washington
Official's Role
Study Chair
Facility Information:
Facility Name
Bayalpata Hospital
City
Sanfebagar
State/Province
Achham
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aradhana Thapa, MPH
Email
aradhana@possiblehealth.org
First Name & Middle Initial & Last Name & Degree
Bikash Gauchan, MBBS
Email
bikash@possiblehealth.org
First Name & Middle Initial & Last Name & Degree
David Citrin, PhD, MPH
Facility Name
Charikot Primary Health Center
City
Bhimeshwor
State/Province
Dolakha
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aradhana Thapa, MPH
Email
aradhana@possiblehealth.org
First Name & Middle Initial & Last Name & Degree
Binod Dangal, MD-GP
Email
binod@possiblehealth.org
First Name & Middle Initial & Last Name & Degree
David Citrin, PhD, MPH

12. IPD Sharing Statement

Links:
URL
http://possiblehealth.org/
Description
Possible
URL
http://hsdg.partners.org/
Description
Healthcare Systems Design Group

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Integrating Pediatric Care Delivery in Rural Healthcare Systems

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