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Effectiveness of Simulation Based Training in Implementing One Hour Bundle Sepsis

Primary Purpose

Medical Education, Simulation Training, Sepsis

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Simulation training
Case-based discussion training
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Medical Education focused on measuring medical education, simulation training, sepsis, high-fidelity manikin, one-hour bundle sepsis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Cipto Mangunkusumo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Simulation group

Conventional group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 18, 2021
Last Updated
September 29, 2021
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05076721
Brief Title
Effectiveness of Simulation Based Training in Implementing One Hour Bundle Sepsis
Official Title
The Role of Simulation-Based Training to Improve Team Performance in Implementing One Sepsis Hour Bundle in Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 22, 2020 (Actual)
Primary Completion Date
October 24, 2020 (Actual)
Study Completion Date
October 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
This was an experimental randomized single-blind study to examine the role of simulation-based training in improving team performance in conducting sepsis management. Subjects were sixteen doctors and twenty-four nurses working in the intensive care unit. The subjects were randomly divided into two treatment groups: the discussion group and the simulation group. Each treatment group was further divided into four small groups consisting of two doctors and three nurses. Prior to the training, every subject received a pretest for cognitive evaluation and a posttest at the end of the training. The performance of both groups in implementing one-hour sepsis bundle was assessed by solving a sepsis case in high fidelity manikin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medical Education, Simulation Training, Sepsis
Keywords
medical education, simulation training, sepsis, high-fidelity manikin, one-hour bundle sepsis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simulation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional group
Arm Type
Experimental
Arm Description
The conventional training group will receive a case-based discussion of a sepsis case which will see the participants implementing one-hour bundle sepsis.
Intervention Type
Other
Intervention Name(s)
Simulation training
Intervention Description
The participants in the simulation group will receive simulation training with high-fidelity manikin to practice and implement one-hour bundle sepsis
Intervention Type
Other
Intervention Name(s)
Case-based discussion training
Intervention Description
The participants in the conventional group will only do a case-based discussion in implementing one-hour bundle sepsis
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
upon study completion, in 1 day
Secondary Outcome Measure Information:
Title
Differences in intrateam communication's score in implementing one hour sepsis bundle assessed with checklist which were designed by four anesthsiologist-intensivists
Description
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.
Time Frame
upon study completion, in 1 day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Doctors working in Dr. Cipto Mangunkusumo Public Hospital's ICU Nurses working in Dr. Cipto Mangunkusumo Public Hospital's ICU Exclusion Criteria: Doctors and nurses who are not fit or healthy to undergo this training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
adhrie sugiarto, MD
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Simulation Based Training in Implementing One Hour Bundle Sepsis

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