- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05076721
Effectiveness of Simulation Based Training in Implementing One Hour Bundle Sepsis
September 29, 2021 updated by: Adhrie Sugiarto, Indonesia University
The Role of Simulation-Based Training to Improve Team Performance in Implementing One Sepsis Hour Bundle in Intensive Care Unit
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto mangunkusumo general hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
The participants in the conventional group will only do a case-based discussion in implementing one-hour bundle sepsis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: 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.
|
upon study completion, in 1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in intrateam communication's score in implementing one hour sepsis bundle assessed with checklist which were designed by four anesthsiologist-intensivists
Time Frame: 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.
|
upon study completion, in 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adhrie Sugiarto, MD, Indonesia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2020
Primary Completion (Actual)
October 24, 2020
Study Completion (Actual)
October 24, 2020
Study Registration Dates
First Submitted
September 18, 2021
First Submitted That Met QC Criteria
September 29, 2021
First Posted (Actual)
October 13, 2021
Study Record Updates
Last Update Posted (Actual)
October 13, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IndonesiaUAnes117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
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Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
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-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityEnrolling by invitationSevere Sepsis | Severe Sepsis Without Septic ShockUnited States
Clinical Trials on Simulation training
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-
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-
Ondokuz Mayıs UniversityCompletedSimulation Training | Vital SignsTurkey
-
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-
Okan UniversityCompletedSimulation | Nursing Education | Preoperative Care | Clinical PracticeTurkey
-
Bogomolets National Medical UniversityCompletedCritical Illness | Intubation; Difficult or Failed | Educational ProblemsUkraine
-
University of OxfordCompleted
-
Hadassah Medical OrganizationClalit Health Services; Israel Center for Medical Simulation (MSR); The Samuel...UnknownEnd of Life ProcessIsrael
-
Sheba Medical CenterSuspendedEducation, HealthIsrael