跳至主要内容
临床试验/NCT03924570
NCT03924570已完成不适用

Multicenter Study to Reduce Adverse Events in Pediatric Intensive Care Units in Argentina Using a Program to Improve the Transfer of Patients

Institute for Clinical Effectiveness and Health Policy5 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
5
主要终点
Frequency of preventable damages associated with medical care measured with GAPPS® (Global Assessment of Pediatric Patient Safety)

研究概览

简要总结

Introduction: Errors in communication, and during transfers of information and medical responsibility, are frequent and risky. Objectives: Primary: To evaluate the effect of the implementation of the I-PASS® transfer program on the reduction in the frequency of medical attention errors in intensive pediatric therapies in the public hospitals setting. Secondary: 1) Measure the effect of the intervention in increasing the frequency of use of key elements of high quality verbal and written communication during the transfer of patients by health professionals. 2) To explore the effect of the intervention on the culture of patient safety among health professionals who assist pediatric patients in areas of clinical hospitalization. Material and Methods: Design: Staged clinical trial (Stepped Wedge) Duration: 9 months (progressive enrollment of 2 participating units every 2 months). Scope: Pediatric Intensive Care Units Subjects: health professionals involved in transfers in each institution. Intervention: Implementation of a multi-faceted evidence-based transfer package (I-PASS®) that has already been adapted for use in Argentina. The program includes multiple components, including educational training, implementation of a mnemonic verbal and written delivery rule I-PASS®, live observations of transfers to drive continuous improvement of the quality of intervention, through the feedback and a campaign of visual reinforcement materials to ensure sustainability. Events of interest: acceptance of the intervention. Frequency of preventable damages associated with medical care measured with GAPPS® as screening tools. Safety culture survey. Length of the transfer before and after the intervention.

详细描述

Objectives: Primary: To evaluate the effect of the implementation of the I-PASS® transfer program on the reduction in the frequency of medical attention errors in intensive pediatric therapies in the public hospitals setting. Secondary: 1) Measure the effect of the intervention in increasing the frequency of use of key elements of high quality verbal and written communication during the transfer of patients by health professionals. 2) To explore the effect of the intervention on the culture of patient safety among health professionals who assist pediatric patients in areas of clinical hospitalization. Material and Methods: Design: Staged clinical trial (Stepped Wedge) Duration: 9 months (progressive enrollment of 2 participating units every 2 months). Scope: Pediatric Intensive Care Units Subjects: health professionals involved in transfers in each institution. Intervention: Implementation of a multi-faceted evidence-based transfer package (I-PASS®) that has already been adapted for use in Argentina. The program includes multiple components, including educational training, implementation of a mnemonic verbal and written delivery rule I-PASS®, live observations of transfers to drive continuous improvement of the quality of intervention, through the feedback and a campaign of visual reinforcement materials to ensure sustainability. Events of interest: acceptance of the intervention. Frequency of preventable damages associated with medical care measured with GAPPS® as screening tools. Safety culture survey. Length of the transfer before and after the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Health professionals (physicians only) which are currently hired as permanent staff of the participant unit
  • Pediatrics medical Residents or other medical personnel in training from the pediatric ICUs enrolled.

排除标准

  • Health professionals (physicians only) with a non permanent contract (replacements) from the pediatric ICUs enrolled.
  • Health professionals other than physicians working in the participant unit.

结局指标

主要结局

Frequency of preventable damages associated with medical care measured with GAPPS® (Global Assessment of Pediatric Patient Safety)

时间窗: measured monthly along 11 months from 6/1/18 to 4/30/19

GAPSS (retrospective chart review procedure to identify adverse events in pediatric hospitalizations) will be used to evaluate frequency of preventable adverse events in both arms

次要结局

  • IPASS usage(measured monthly along 11 months from 6/1/18 to 4/30/19)
  • Safety culture of the professionals involved in hands off: survey(At month 1 (June 2018) and at month 11 (April 2019) of data collection period.)

研究者

发起方
Institute for Clinical Effectiveness and Health Policy
申办方类型
Other
责任方
Sponsor

研究点 (5)

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