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临床试验/NCT04192799
NCT04192799已完成不适用

Comparative Effectiveness of Direct Admission & Admission Through Emergency Departments for Children

Dartmouth-Hitchcock Medical Center3 个研究点 分布在 1 个国家目标入组 1,997 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,997
试验地点
3
主要终点
Timeliness of Clinical Care - Initial Therapeutic Management

研究概览

简要总结

At a national level, emergency departments (EDs) serve as the portal of hospital admission for 75% of hospitalized children. The remainder occur via direct admission, defined as admission to hospital without first receiving care in the hospital's ED. The overall goals of this research are to: (i) implement pediatric direct admission systems at 3 hospitals, (ii) compare the timeliness of healthcare delivery for children who are admitted directly and through emergency departments, (iii) determine which patient populations achieve the greatest benefits from direct admission, and (iv) identify barriers and facilitators of successful implementation.

详细描述

The Specific Aims of this research are to: (i) Determine the effect of a pediatric direct admission system on timeliness of healthcare provision (the investigator's primary outcome), family experience of care, and rates of clinical deterioration compared to hospital admission beginning in the ED; (ii) Identify the pediatric populations and conditions that experience the greatest benefits from direct admission; and (iii) Through interviews with key informants, identify barriers to and facilitators of implementing standardized direct admission processes.

To achieve these Aims, a stepped-wedge cluster randomized controlled trial at three geographically diverse hospitals in the United States will be conducted, randomizing primary and urgent care practices in the hospitals' catchment area to cross over to the direct admission intervention at four time points. Linear models with random effects for clusters and time period fixed effects will be used to evaluate outcomes associated with the direct admission intervention. To examine for heterogeneity of treatment effects, interactions between direct admission and a priori-specified subgroups will be examined.

研究设计

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

入排标准

年龄范围
30 Days 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Child has one of the following presenting diagnoses:
  • •gastroenteritis
  • •dehydration
  • •skin and soft tissue infection
  • •urinary tract infection/pyelonephritis
  • •pneumonia
  • •viral infection not otherwise specified
  • •influenza

排除标准

  • •Ineligible children include those:
  • •with planned admissions (i.e., chemotherapy)
  • •admitted to non-pediatric hospital medicine services (i.e., intensive care)
  • •transferred from other hospitals

研究组 & 干预措施

Direct Admission

Experimental

Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit.

干预措施: Direct admission (Behavioral)

ED Admission

Active Comparator

Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit.

干预措施: ED admission (Behavioral)

结局指标

主要结局

Timeliness of Clinical Care - Initial Therapeutic Management

时间窗: within 6 hours of hospital admission

Length of time from arrival at the hospital until time of first antibiotics, IV placement, fluid administration, or other medications

Timeliness of Clinical Care - Initial Clinical Assessment

时间窗: within 6 hours of hospital admission

Length of time from arrival at the hospital until first time when at least 3 vital signs were documented; if missing, time of initial brief nursing assessment

Timeliness of Clinical Care - Initial Diagnostic Testing

时间窗: within 6 hours of hospital admission

Length of time from arrival at the hospital until time of initial labs and/or imaging, including "standing orders" for diagnostic testing in emergency departments

次要结局

  • Number of Participants With Clinical Deterioration(within 6 hours of arrival on the inpatient unit)
  • Pediatric Hospitalization Admission Survey of Experience (PHASE)(Within 72 hours of hospital admission)

研究者

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

JoAnna K. Leyenaar

Vice Chair of Research and Associate Professor, Department of Pediatrics

Dartmouth-Hitchcock Medical Center

研究点 (3)

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