Reducing Adverse Events in Pediatric Intensive Care Units in Argentina

Sponsor
Institute for Clinical Effectiveness and Health Policy (Other)
Overall Status
Unknown status
CT.gov ID
NCT03924570
Collaborator
Hospital JP Garrahan (Other), Ministry of Public Health, Argentina (Other)
72
5
2
14.5
14.4
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: IPASS
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Stepped Wedge TrialStepped Wedge Trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Multicenter Study to Reduce Adverse Events in Pediatric Intensive Care Units in Argentina Using a Program to Improve the Transfer of Patients
Actual Study Start Date :
Jul 15, 2018
Anticipated Primary Completion Date :
Aug 15, 2019
Anticipated Study Completion Date :
Sep 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 4/30/19]

    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

Secondary Outcome Measures

  1. IPASS usage [measured monthly along 11 months from 6/1/18 to 4/30/19]

    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)

  2. 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.]

    Safety culture survey from AHRQ will be administered to participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Municipal del Niño de San Justo San Justo Buenos Aires Argentina
2 Hospital materno infantil héctor Quintana San Salvador de Jujuy Jujuy Argentina
3 Hospital de Niños Dr. Ricardo Gutiérrez Buenos Aires Argentina
4 Hospital Pedro de Elizalde Buenos Aires Argentina
5 Prof. Dr. Juan P. Garrahan Buenos Aires Argentina

Sponsors and Collaborators

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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institute for Clinical Effectiveness and Health Policy
ClinicalTrials.gov Identifier:
NCT03924570
Other Study ID Numbers:
  • NRU3126
First Posted:
Apr 23, 2019
Last Update Posted:
Aug 8, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 8, 2019