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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03924570
Enrollment
72
Registered
2019-04-23
Start date
2018-07-15
Completion date
2019-09-30
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Errors, Preventable Adverse Events

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.

Interventions

BEHAVIORALIPASS

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

Sponsors

Hospital JP Garrahan
CollaboratorOTHER_GOV
Ministry of Public Health, Argentina
CollaboratorOTHER_GOV
Institute for Clinical Effectiveness and Health Policy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Stepped Wedge Trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 4/30/19GAPSS (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

MeasureTime frameDescription
IPASS usagemeasured monthly along 11 months from 6/1/18 to 4/30/19Frequency 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

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026