Effectiveness of Simulation Based Training in Implementing One Hour Bundle Sepsis

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT05076721

Collaborator

(none)

Enrollment

Location

Arms

2.1

Actual Duration (Months)

19.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Medical Education Simulation Training Sepsis	Other: Simulation training Other: Case-based discussion training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

The Role of Simulation-Based Training to Improve Team Performance in Implementing One Sepsis Hour Bundle in Intensive Care Unit

Actual Study Start Date :

Aug 22, 2020

Actual Primary Completion Date :

Oct 24, 2020

Actual Study Completion Date :

Oct 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Simulation group 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 The participants in the simulation group will receive simulation training with high-fidelity manikin to practice and implement one-hour bundle sepsis
Experimental: Conventional group 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 The participants in the conventional group will only do a case-based discussion in implementing one-hour bundle sepsis

Arm

Intervention/Treatment

Experimental: Simulation group

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

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

Experimental: Conventional group

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

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

Outcome Measures

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 [upon study completion, in 1 day]
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 [upon study completion, in 1 day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

Principal Investigator: adhrie sugiarto, MD, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adhrie Sugiarto, Principal Investigator, Indonesia University

ClinicalTrials.gov Identifier:

NCT05076721

Other Study ID Numbers:

IndonesiaUAnes117

First Posted:

Oct 13, 2021

Last Update Posted:

Oct 13, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Adhrie Sugiarto, Principal Investigator, Indonesia University

medical education

simulation training

sepsis

high-fidelity manikin

one-hour bundle sepsis

Additional relevant MeSH terms:

Sepsis

Toxemia

Study Results

No Results Posted as of Oct 13, 2021