Reducing Adverse Events in Pediatric Intensive Care Units in Argentina

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

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.

Study Overview

• Status: Unknown
• Conditions: Medical Errors; Preventable Adverse Events
• Intervention / Treatment: Behavioral: IPASS

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ezequiel Garcia Elorrio, MD; Phone Number: 0111544000624; Email: egarciaelorrio@iecs.org.ar
• Study Contact Backup: Name: Claudia Arizaga, BA; Phone Number: 0111544000624; Email: carizaga@iecs.org.ar

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Recruiting
    • Hospital de Niños Dr. Ricardo Gutierrez
    • Contact: Gisela Rodriguez, MD
  • Buenos Aires, Argentina
    • Recruiting
    • Hospital Pedro de Elizalde
    • Contact: Facundo Jorro Baron, MD
  • Buenos Aires, Argentina
    • Recruiting
    • Prof. Dr. Juan P. Garrahan
    • Contact: Luis Landry, MD
  • Buenos Aires
    • San Justo, Buenos Aires, Argentina
      • Recruiting
      • Hospital Municipal del Nino de San Justo
      • Contact: Matias Penazzi, MD
  • Jujuy
    • San Salvador de Jujuy, Jujuy, Argentina
      • Recruiting
      • Hospital materno infantil héctor Quintana
      • Contact: Rodrigo Burgos Praxt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; This arm will receive training in the use of the IPASS package to improve communications during hands off.	Behavioral: IPASS; IPASS is behavioral package to improve transitions of care by providing a framework to hands off.
NO_INTERVENTION: Control; Until randomization this arm will continue running hands offs per usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of preventable damages associated with medical care measured with GAPPS® (Global Assessment of Pediatric Patient Safety)	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	measured monthly along 11 months from 6/1/18 to 4/30/19

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPASS usage	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)	measured monthly along 11 months from 6/1/18 to 4/30/19
Safety culture of the professionals involved in hands off: survey	Safety culture survey from AHRQ will be administered to participants	At month 1 (June 2018) and at month 11 (April 2019) of data collection period.

Collaborators and Investigators

• Sponsor: Institute for Clinical Effectiveness and Health Policy
• Collaborators: Ministry of Public Health, Argentina; Hospital JP Garrahan
• Investigators: Principal Investigator: Ezequiel Garcia Elorrio, MD, Director. Quality and Safety in Healthcare. IECS; Principal Investigator: Luis Landry, MD, Director. Intensive Care Unit. Hospital Pedro Garrahan

Publications and helpful links

General Publications

• Jorro-Baron F, Suarez-Anzorena I, Burgos-Pratx R, De Maio N, Penazzi M, Rodriguez AP, Rodriguez G, Velardez D, Gibbons L, Abalos S, Lardone S, Gallagher R, Olivieri J, Rodriguez R, Vassallo JC, Landry LM, Garcia-Elorrio E. Handoff improvement and adverse event reduction programme implementation in paediatric intensive care units in Argentina: a stepped-wedge trial. BMJ Qual Saf. 2021 Oct;30(10):782-791. doi: 10.1136/bmjqs-2020-012370. Epub 2021 Apr 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2018
• Primary Completion (ANTICIPATED): August 15, 2019
• Study Completion (ANTICIPATED): September 30, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: April 21, 2019
• First Posted (ACTUAL): April 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NRU3126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No