跳至主要内容
临床试验/NCT07304050
NCT07304050尚未招募不适用

Pilot Randomized Controlled Trial of PICTURE-Pediatric

University of Michigan1 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
375
试验地点
1
主要终点
Compliance with the model workflow as measured by a pop-up questionnaire after each model alert aggregated as a proportion -clinicians

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness and user satisfaction of the study teams early warning system, called PICTURE, which utilizes artificial intelligence (AI) techniques and algorithms to identify patient deterioration on pediatric units within Mott Children's Hospital.

In this pilot study the patient care team will review the PICTURE information and alerts. Morning rounds will be partially informed by the PICTURE scores and the scores will be included in the hand off notes for the patients with a red score.

The primary purpose of this study is to test the hypothesis that the combination of the PICTURE-Pediatric model, the proposed workflow and the proposed interface results in at least 80% compliance.

No participants will be consented as the Institutional review board has approved a waiver of consent for THE clinicians and the patients information being reviewed.

The enrollment numbers will include only the clinicians.

详细描述

PICTURE Pediatric evaluates large amounts of patient data, labs, monitored data, and vital signs (all variables that are measured as part of routine clinical care and that are stored in the electronic health record in real-time); it does this every 15-minutes and delivers a deterioration risk index score that has been shown to outperform Pediatric Early Warning Score (PEWS), and other similar scoring systems in identifying patients at risk for clinical deterioration. Clinical implementation of PICTURE Pediatric could identify patients at high risk of deterioration early enough to intervene and decrease the need for transfer to the Pediatric Intensive Care unit (PICU), and it could also reduce morbidity and hospital length of stay. This in turn could also improve bed availability for patients awaiting admission in the emergency department and improve efficient transfer out of the PICU, all of which improves care and reduces cost for the patients, their families, and the hospital system.

This protocol also does not mandate or require clinical decisions based on alerts generated (e.g. there is no mandate to transfer to the Intensive Care unit, perform an intervention, or change therapy/clinical course based on PICTURE alerts); rather, the clinical team will decide whether additional investigation, therapy, intervention, or transfer is required after alerts are generated based on staff's clinical experience, knowledge and with consultation with an attending physician when applicable. In case of device failure, there would be no deterioration risk scores generated and the clinical teams would simply continue to follow the current workflow.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
30 Days 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients:
  • Age ≥30 days and ≤25 years
  • Be on the general care wards of Mott Children's Hospital or boarding in the Emergency Department (ED), but admitted to a pediatric floor medical team. These will be enforced by these criteria:
  • Patient class: not emergency b. Patient level of care: not Intensive Care unit (ICU) c. Patient locations (per protocol)

排除标准

  • Patients:
  • Patients that do not meet the inclusion criteria

结局指标

主要结局

Compliance with the model workflow as measured by a pop-up questionnaire after each model alert aggregated as a proportion -clinicians

时间窗: within 30 minutes after each alert during a patient's admission

Responses to the questions measure compliance with the workflow. Compliance will be measured as binary outcomes (i.e., compliant and noncompliant) and aggregated as a proportion.

次要结局

  • Feasibility of Intervention Measure (FIM)-clinicians(At the end of the study (approximately 4 months after the start of the enrollment))
  • Acceptability of Intervention Measure (AIM)-clinicians(At the end of the study (approximately 4 months after the start of the enrollment))
  • Intervention Appropriateness Measure (IAM)-clinicians(At the end of the study (approximately 4 months after the start of the enrollment))

研究者

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

Rodney Daniels

Clinical Associate Professor

University of Michigan

研究点 (1)

Loading locations...

相似试验