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临床试验/NCT02128776
NCT02128776已完成不适用

Comprehensive Care Provided in an Enhanced Medical Home to Improve Outcomes and Reduce Costs for High-Risk Chronically Ill Children

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
2
主要终点
Cost per prevented child with serious illness

研究概览

简要总结

The purpose of this study is to assess whether an enhanced medical home providing comprehensive care is cost-effective in preventing serious illness (death, pediatric intensive care admission, or hospital stay >7d) among high-risk chronically ill children.

详细描述

INTRODUCTION

Although the patient-centered medical home is widely recommended to promote cost-effective healthcare1-6, it has not been shown in systematic reviews to improve clinical outcomes or reduce medical costs.3,4 Medical homes have greatest potential value for high-risk patients, including chronically ill children whose care is often fragmented, costly, and ineffective. However, the justifiably stringent requirements for practice guidelines and the necessity to control health care costs require compelling evidence of cost-effectiveness before undertaking all that will be required to disseminate the patient-centered medical home for high-risk chronically ill children throughout the U.S. For this reason we propose a randomized trial to assess whether an enhanced medical home providing comprehensive care is cost-effective in preventing serious illness (death, pediatric intensive care admission, or hospital stay >7d) among high-risk chronically ill children in our center. Our study obtained expedited approval by our Institutional Review Board (IRB) as a quality improvement (QI) study.

METHODS

After verbal informed parental consent is obtained (as allowed by our institutional review board for a minimal-risk QI trial to increase access to care), children are randomized (using sealed, opaque, sequentially numbered envelopes) to usual care or comprehensive care after stratification by maternal education (high school graduate or not) and predicted risk of hospitalization (50-74%; >75%).

Comprehensive Care involves care for acute and chronic problems from an ethnically diverse team of pediatricians and pediatric nurse practitioners (PNPs) who are highly trained and experienced in treating these complex, fragile children and available at all hours by phone and 40 hours/week in a special high-risk children's clinic. This clinic serves as a novel medical home where both primary and specialty services are provided in the same clinic at the same visit. The clinic is also staffed by a nutritionist and social worker and attended monthly by a dedicated subspecialist in pediatric gastroenterology, in neurology, and in allergy/immunology. A pediatric infectious disease specialist helped develop measures to reduce, promptly diagnose, and effectively treat infections. These subspecialists are available by phone for consultation at all hours. Acute problems presenting before 5 pm are seen that day; those occurring on weekends or nights are seen the next weekday in the morning. At any hour an emergency department (ED) visit or hospitalization is needed, our staff discusses the child with the responsible MD and schedules prompt follow-up visits. Multiple measures, e.g., recording and staff review of phone calls; daily checks of ED and hospital logs; detailed review of all care before hospitalizations; parent surveys; and active input of our Parent Advisory Board, are used to promote highest quality of care.

研究设计

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

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years old or younger with a chronic illness, high healthcare utilization (>3 emergency department visits, >2 hospitalizations or >1 pediatric intensive care unit admission in the prior year), and a >50% likelihood of hospitalization in the coming year (as estimated from the patient's diagnosis and clinical course by our clinic's medical director), who lived within a one-hour commute of our center.

排除标准

  • Patients with complex problems given primary care by a specialist at all hours (e.g. infants in our neonatal follow-up program and children with serious unrepaired congenital heart disease, a mitochondrial disorder, organ transplant, treatment with dialysis or central lines; or a do-not-resuscitate order).

结局指标

主要结局

Cost per prevented child with serious illness

时间窗: Up to 2 and 1/2 years

Cost per prevented child with serious illness

次要结局

  • Total costs of care(Up to 2 and 1/2 years)
  • Episodes of serious illnesses(Up to 2 and 1/2 years)
  • Emergency department visits(Up to 2 and 1/2 years)
  • Hospitalizations(Up to 2 and 1/2 years)
  • Intensive care admissions(Up to 2 and 1/2 years)
  • Parent ratings of care at the end of 1st year(12 months after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon Edward Tyson

Michelle Bain Distinguished Professor, Vice Dean for Healthcare Quality and Clinical Research

The University of Texas Health Science Center, Houston

研究点 (2)

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