Reducing Adverse Events in Pediatric Intensive Care Units in Argentina

NCT ID: NCT03924570

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2019-09-30

Brief Summary

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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

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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

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Medical Errors Preventable Adverse Events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped Wedge Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

IPASS

Intervention Type BEHAVIORAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IPASS

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital JP Garrahan

OTHER_GOV

Sponsor Role collaborator

Ministry of Public Health, Argentina

OTHER_GOV

Sponsor Role collaborator

Institute for Clinical Effectiveness and Health Policy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ezequiel Garcia Elorrio, MD

Role: PRINCIPAL_INVESTIGATOR

Director. Quality and Safety in Healthcare. IECS

Luis Landry, MD

Role: PRINCIPAL_INVESTIGATOR

Director. Intensive Care Unit. Hospital Pedro Garrahan

Locations

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Hospital Municipal del Niño de San Justo

San Justo, Buenos Aires, Argentina

Site Status

Hospital materno infantil héctor Quintana

San Salvador de Jujuy, Jujuy Province, Argentina

Site Status

Hospital de Niños Dr. Ricardo Gutiérrez

Buenos Aires, , Argentina

Site Status

Hospital Pedro de Elizalde

Buenos Aires, , Argentina

Site Status

Prof. Dr. Juan P. Garrahan

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type DERIVED
PMID: 33893213 (View on PubMed)

Other Identifiers

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NRU3126

Identifier Type: -

Identifier Source: org_study_id

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