Multicenter Study to Reduce Adverse Events in Pediatric Intensive Care Units in Argentina Using a Program to Improve the Transfer of Patients

Reducing Adverse Events in Pediatric Intensive Care Units in Argentina

Sponsors

Lead sponsor: Institute for Clinical Effectiveness and Health Policy

Collaborator: Hospital JP Garrahan
Ministry of Public Health, Argentina

Source 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.

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.

Overall Status Recruiting
Start Date July 15, 2018
Completion Date September 30, 2019
Primary Completion Date August 15, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
IPASS usage measured monthly along 11 months from 6/1/18 to 4/30/19
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.
Enrollment 72
Condition
Intervention

Intervention type: Behavioral

Intervention name: IPASS

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

Arm group label: 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.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Overall Contact

Last name: Ezequiel Garcia Elorrio, MD

Phone: 0111544000624

Email: [email protected]

Location
facility status contact
Hospital Municipal del Niño de San Justo | San Justo, Buenos Aires, Argentina Recruiting Matias Penazzi, MD
Hospital materno infantil héctor Quintana | San Salvador de Jujuy, Jujuy, Argentina Recruiting Rodrigo Burgos Praxt, MD
Hospital de Niños Dr. Ricardo Gutiérrez | Buenos Aires, Argentina Recruiting Gisela Rodriguez, MD
Hospital Pedro de Elizalde | Buenos Aires, Argentina Recruiting Facundo Jorro Baron, MD
Prof. Dr. Juan P. Garrahan | Buenos Aires, Argentina Recruiting Luis Landry, MD
Location Countries

Argentina

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Intervention

Arm group type: Experimental

Description: This arm will receive training in the use of the IPASS package to improve communications during hands off.

Arm group label: Control

Arm group type: No Intervention

Description: Until randomization this arm will continue running hands offs per usual care.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Sequential Assignment

Intervention model description: Stepped Wedge Trial

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov