Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03924570 |
| Other study ID # |
NRU3126 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2018 |
| Est. completion date |
September 30, 2019 |
Study information
| Verified date |
April 2024 |
| Source |
Institute for Clinical Effectiveness and Health Policy |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
