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Reducing Adverse Events in Pediatric Intensive Care Units in Argentina

I

Institute for Clinical Effectiveness and Health Policy

Status

Completed

Conditions

Preventable Adverse Events
Medical Errors

Treatments

Behavioral: IPASS

Study type

Interventional

Funder types

Other

Identifiers

NCT03924570
NRU3126

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Intervention
Experimental group
Description:
This arm will receive training in the use of the IPASS package to improve communications during hands off.
Treatment:
Behavioral: IPASS
Control
No Intervention group
Description:
Until randomization this arm will continue running hands offs per usual care.

Trial contacts and locations

5

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Central trial contact

Claudia Arizaga, BA; Ezequiel Garcia Elorrio, MD

Data sourced from clinicaltrials.gov

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