Clinical trial NCT03924570: Reducing Adverse Events in Pediatric Intensive Care Units in Argentina
Official title: Multicenter Study to Reduce Adverse Events in Pediatric Intensive Care Units in Argentina Using a Program to Improve the Transfer of Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Errors
Preventable Adverse Events
Lead sponsor: Institute for Clinical Effectiveness and Health Policy
Sponsor class: OTHER
Collaborators: name: Hospital JP Garrahan
name: Ministry of Public Health, Argentina
First posted: 2019-04-23
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Trial
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Frequency of preventable damages associated with medical care measured with GAPPS® (Global Assessment of Pediatric Patient Safety)
timeFrame: measured monthly along 11 months from 6/1/18 to 4/30/19
Secondary outcomes:
measure: IPASS usage
timeFrame: measured monthly along 11 months from 6/1/18 to 4/30/19
measure: Safety culture of the professionals involved in hands off: survey
timeFrame: At month 1 (June 2018) and at month 11 (April 2019) of data collection period.
Other outcomes:
Locations:
city: San Justo
country: Argentina
facility: Hospital Municipal del Niño de San Justo
state: Buenos Aires
city: San Salvador de Jujuy
country: Argentina
facility: Hospital materno infantil héctor Quintana
state: Jujuy
city: Buenos Aires
country: Argentina
facility: Hospital de Niños Dr. Ricardo Gutiérrez
city: Buenos Aires
country: Argentina
facility: Hospital Pedro de Elizalde
city: Buenos Aires
country: Argentina
facility: Prof. Dr. Juan P. Garrahan
Study officials:
affiliation: Director. Quality and Safety in Healthcare. IECS
name: Ezequiel Garcia Elorrio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director. Intensive Care Unit. Hospital Pedro Garrahan
name: Luis Landry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.