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Reducing Adverse Events in Pediatric Intensive Care Units in Argentina

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ClinicalTrials.gov Identifier: NCT03924570
Recruitment Status : Unknown
Verified August 2019 by Institute for Clinical Effectiveness and Health Policy.
Recruitment status was:  Recruiting
First Posted : April 23, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
Hospital JP Garrahan
Ministry of Public Health, Argentina
Information provided by (Responsible Party):
Institute for Clinical Effectiveness and Health Policy

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
Medical Errors Preventable Adverse Events Behavioral: IPASS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped 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 : July 15, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : September 30, 2019

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.



Primary Outcome Measures :
  1. Frequency of preventable damages associated with medical care measured with GAPPS® (Global Assessment of Pediatric Patient Safety) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924570


Contacts
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Contact: Ezequiel Garcia Elorrio, MD 0111544000624 egarciaelorrio@iecs.org.ar
Contact: Claudia Arizaga, BA 0111544000624 carizaga@iecs.org.ar

Locations
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Argentina
Hospital Municipal del Niño de San Justo Recruiting
San Justo, Buenos Aires, Argentina
Contact: Matias Penazzi, MD         
Hospital materno infantil héctor Quintana Recruiting
San Salvador de Jujuy, Jujuy, Argentina
Contact: Rodrigo Burgos Praxt, MD         
Hospital de Niños Dr. Ricardo Gutiérrez Recruiting
Buenos Aires, Argentina
Contact: Gisela Rodriguez, MD         
Hospital Pedro de Elizalde Recruiting
Buenos Aires, Argentina
Contact: Facundo Jorro Baron, MD         
Prof. Dr. Juan P. Garrahan Recruiting
Buenos Aires, Argentina
Contact: Luis Landry, MD         
Sponsors and Collaborators
Institute for Clinical Effectiveness and Health Policy
Hospital JP Garrahan
Ministry of Public Health, Argentina
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institute for Clinical Effectiveness and Health Policy
ClinicalTrials.gov Identifier: NCT03924570    
Other Study ID Numbers: NRU3126
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No