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Completed

NCT Number: NCT03924570

Reducing Adverse Events in Pediatric Intensive Care Units in Argentina

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.

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Key information

Conditions

Medical Errors Preventable Adverse Events

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Municipal del Niño de San Justo, San Justo, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IPASS

Behavioral

IPASS is behavioral package to improve transitions of care by providing a framework to hands off.

Primary outcomes

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

    Time frame: 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 outcomes

  1. IPASS usage

    Time frame: measured 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)

  2. Safety culture of the professionals involved in hands off: survey

    Time frame: At month 1 (June 2018) and at month 11 (April 2019) of data collection period.

    Safety culture survey from AHRQ will be administered to participants

Sponsors and collaborators

Lead sponsor

Institute for Clinical Effectiveness and Health Policy

Other

Collaborators

  • Hospital JP Garrahan
  • Ministry of Public Health, Argentina

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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