跳至主要内容
临床试验/NCT02331082
NCT02331082Unknown不适用

Integrating Pediatric Care Delivery in Rural Healthcare Systems

Possible2 个研究点 分布在 1 个国家目标入组 7,000 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
7,000
试验地点
2
主要终点
Infant mortality rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Control

Active Comparator

Existing healthcare system

干预措施: Existing healthcare system (Other)

Health System Improvement

Experimental

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

干预措施: Structured Quality Improvement (Other)

Health System Improvement

Experimental

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

干预措施: Chronic Care Model (Other)

Health System Improvement

Experimental

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

干预措施: Integrated Electronic Medical Record (Device)

Health System Improvement

Experimental

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

干预措施: Solar-powered electrical supply (Device)

Health System Improvement

Experimental

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

干预措施: Performance-based financing (Behavioral)

结局指标

主要结局

Infant mortality rate

时间窗: 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

时间窗: Five years

We expect the intervention will lead to a 25% decrease in under-two mortality in the experimental arm.

Neonatal mortality rate

时间窗: Five years

We expect the intervention will lead to a 25% decrease in the neonatal mortality rate in the experimental arm.

次要结局

  • Percentage of stillbirths(Five years)
  • Postpartum contraceptive prevalence rate(Five years)
  • Institutional Birth Rate(Five years)
  • Antenatal Care Completion Percentage(Five years)
  • Preterm delivery rate(Five years)
  • Low birthweight delivery rates(Five years)

研究者

发起方
Possible
申办方类型
Other
责任方
Sponsor

研究点 (2)

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