MedPath

Reducing Adverse Events in Pediatric Intensive Care Units in Argentina

Not Applicable
Completed
Conditions
Preventable Adverse Events
Medical Errors
Interventions
Behavioral: IPASS
Registration Number
NCT03924570
Lead Sponsor
Institute for Clinical Effectiveness and Health Policy
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
72
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
InterventionIPASSThis arm will receive training in the use of the IPASS package to improve communications during hands off.
Primary Outcome Measures
NameTimeMethod
Frequency of preventable damages associated with medical care measured with GAPPS® (Global Assessment of Pediatric Patient Safety)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

Secondary Outcome Measures
NameTimeMethod
IPASS usagemeasured monthly along 11 months from 6/1/18 to 4/30/19

Frequency of the use of key elements of IPASS for verbal or oral content quality of a sample of transfers (through a checklist administered by an independent observer)

Safety culture of the professionals involved in hands off: surveyAt month 1 (June 2018) and at month 11 (April 2019) of data collection period.

Safety culture survey from AHRQ will be administered to participants

Trial Locations

Locations (5)

Hospital materno infantil héctor Quintana

🇦🇷

San Salvador de Jujuy, Jujuy, Argentina

Hospital de Niños Dr. Ricardo Gutiérrez

🇦🇷

Buenos Aires, Argentina

Prof. Dr. Juan P. Garrahan

🇦🇷

Buenos Aires, Argentina

Hospital Municipal del Niño de San Justo

🇦🇷

San Justo, Buenos Aires, Argentina

Hospital Pedro de Elizalde

🇦🇷

Buenos Aires, Argentina

© Copyright 2025. All Rights Reserved by MedPath