NCT05076721

Brief Summary

This study aimed to compare simulation training with conventional training (case-based discussion only) to improve team performance in implementing one-hour sepsis bundle in the intensive care unit

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
Last Updated

October 13, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

September 18, 2021

Last Update Submit

September 29, 2021

Conditions

Keywords

medical educationsimulation trainingsepsishigh-fidelity manikinone-hour bundle sepsis

Outcome Measures

Primary Outcomes (1)

  • Differences in score of skills in implementing one-hour bundle sepsis in the intensive care unit assessed with checklist which were designed by four anesthesiologist-intensivists

    Measured by checklist which were designed by four anesthesiologist-intensivists before the study was conducted and validated by Aiken coefficient. The Aiken coefficient for this checklist were all \>0.3 which is declared valid.

    upon study completion, in 1 day

Secondary Outcomes (1)

  • Differences in intrateam communication's score in implementing one hour sepsis bundle assessed with checklist which were designed by four anesthsiologist-intensivists

    upon study completion, in 1 day

Study Arms (2)

Simulation group

EXPERIMENTAL

The simulation training group will receive a simulation training of a sepsis case which will see the participants implementing one-hour bundle sepsis with a high-fidelity manikin.

Other: Simulation training

Conventional group

EXPERIMENTAL

The conventional training group will receive a case-based discussion of a sepsis case which will see the participants implementing one-hour bundle sepsis.

Other: Case-based discussion training

Interventions

The participants in the simulation group will receive simulation training with high-fidelity manikin to practice and implement one-hour bundle sepsis

Simulation group

The participants in the conventional group will only do a case-based discussion in implementing one-hour bundle sepsis

Conventional group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Doctors working in Dr. Cipto Mangunkusumo Public Hospital's ICU
  • Nurses working in Dr. Cipto Mangunkusumo Public Hospital's ICU

You may not qualify if:

  • Doctors and nurses who are not fit or healthy to undergo this training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • adhrie sugiarto, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2021

First Posted

October 13, 2021

Study Start

August 22, 2020

Primary Completion

October 24, 2020

Study Completion

October 24, 2020

Last Updated

October 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations