Reducing Adverse Events in Pediatric Intensive Care Units in Argentina

NCT03924570 | Completed

• 1 other identifier: NRU3126
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 5

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.

Conditions

Medical Errors; Preventable Adverse Events

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Intervention

EXPERIMENTAL

This arm will receive training in the use of the IPASS package to improve communications during hands off.

Behavioral: IPASS

Control

NO INTERVENTION

Until randomization this arm will continue running hands offs per usual care.

Interventions

IPASS BEHAVIORAL

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Clinical Effectiveness and Health Policy: lead
• Hospital JP Garrahan: collaborator
• Ministry of Public Health, Argentina: collaborator

Study Sites (5)

Hospital Municipal del Niño de San Justo

San Justo, Buenos Aires, Argentina

Location

Hospital materno infantil héctor Quintana

San Salvador de Jujuy, Jujuy Province, Argentina

Location

Hospital de Niños Dr. Ricardo Gutiérrez

Buenos Aires, Argentina

Location

Hospital Pedro de Elizalde

Buenos Aires, Argentina

Location

Prof. Dr. Juan P. Garrahan

Buenos Aires, Argentina

Location

Related Publications (1)

• 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.

  PMID: 33893213 DERIVED

Study Officials

• Ezequiel Garcia Elorrio, MD

  Director. Quality and Safety in Healthcare. IECS

  PRINCIPAL INVESTIGATOR

• Luis Landry, MD

  Director. Intensive Care Unit. Hospital Pedro Garrahan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped Wedge Trial

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: April 23, 2019
• Study Start: July 15, 2018
• Primary Completion: August 15, 2019
• Study Completion: September 30, 2019
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (5)