Medical EducationNCT05076721
Effectiveness of Simulation Based Training in Implementing One Hour Bundle Sepsis
A study testing Simulation training and Case-based discussion training in people with Medical Education and Simulation Training, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Education, Simulation Training, Sepsis
- What is being tested?
- Simulation training and Case-based discussion training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 22 Aug 2020to 24 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Doctors working in Dr. Cipto Mangunkusumo Public Hospital's ICU
- Nurses working in Dr. Cipto Mangunkusumo Public Hospital's ICU
Who cannot join
- Doctors and nurses who are not fit or healthy to undergo this training
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: 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
Read the 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.
- Conditions
- Medical Education, Simulation Training, Sepsis
- Being tested
- Simulation training, Case-based discussion training
- Keywords
- medical education, simulation training, sepsis, high-fidelity manikin, one-hour bundle sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation trainingOther
The participants in the simulation group will receive simulation training with high-fidelity manikin to practice and implement one-hour bundle sepsis
Case-based discussion trainingOther
The participants in the conventional group will only do a case-based discussion in implementing one-hour bundle sepsis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Case-based discussion training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: upon study completion, in 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start22 Aug 2020
- Primary completion24 Oct 2020
- Study completion24 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhrie Sugiarto, Universitas Indonesia
- Investigators
- adhrie sugiarto, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076721
- Sponsor's protocol ID
- IndonesiaUAnes117
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Simulation-Based Training to Improve Team Performance in Implementing One Sepsis Hour Bundle in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05076721
- Acronym / sponsor ID
- IndonesiaUAnes117
- Conditions
- Medical Education, Simulation Training, Sepsis
- Keywords
- medical education, simulation training, sepsis, high-fidelity manikin, one-hour bundle sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 22 Aug 2020 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- 24 Oct 2020 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation group | Experimental | Other: Simulation trainingThe 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. |
| Conventional group | Experimental | Other: Case-based discussion trainingThe conventional training group will receive a case-based discussion of a sepsis case which will see the participants implementing one-hour bundle sepsis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Doctors working in Dr. Cipto Mangunkusumo Public Hospital's ICU
- Nurses working in Dr. Cipto Mangunkusumo Public Hospital's ICU
Key exclusion criteria (1 listed)
- Doctors and nurses who are not fit or healthy to undergo this training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation trainingThe participants in the simulation group will receive simulation training with high-fidelity manikin to practice and implement one-hour bundle sepsis | Other | Simulation group |
| Case-based discussion trainingThe participants in the conventional group will only do a case-based discussion in implementing one-hour bundle sepsis | Other | Conventional group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
adhrie sugiarto, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation training and Case-based discussion training in people with Medical Education and Simulation Training, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.