Simulation of Physical IllnessNCT05113823
In Situ Simulation Training in Transferring Critically Ill COVID-19 Patients
A study testing Simulation Training in people with Simulation of Physical Illness and COVID-19 Respiratory Infection, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to determine the role of in situ simulation training during a pandemic by using standard and high-fidelity mannequins to improve interprofessional communication, skills, and teamwork in transferring critically ill COVID-19 patients. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulation of Physical Illness, COVID-19 Respiratory Infection
- What is being tested?
- Simulation Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Nov 2020to 15 Mar 2021
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in good physical condition
- had no history of involving in COVID-19 patients care
- willing to become study subject
Who cannot join
- doesn't want to become study subject
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: In Situ Simulation Training for a Better Interprofessional Team Performance in Transferring Critically Ill COVID-19 Patients: A Prospective Randomized Control Trial
This study aimed to determine the role of in situ simulation training during a pandemic by using standard and high-fidelity mannequins to improve interprofessional communication, skills, and teamwork in transferring critically ill COVID-19 patients.
Read the detailed description
Fourty subjects were randomly allocated into two large groups, the High Fidelity Simulator group and the Low Fidelity Simulator group. Each group was divided into small groups, consist of 2 doctors and 3 nurses. All subjects underwent the same interactive lectures, and two sessions of in-situ simulation according to their assign group. In-situ simulation and debriefing were performed by implementing appropriate personal protective equipment and social distancing. At the end of each simulation session, each group would underwent a debriefing session, which was performed by an experience instructor. The first simulation was aimed to teach participants skills and steps in transporting critically-ill COVID-19 patients according to the hospital check-list. While the second simulation was aimed to assess skills, team work and communication that participants had learned from the previous simulation, by using assessment tools that had been developed before. In addition to comparing each point in the assessment tool between the two groups, the points that had been earned were also added up to get the overall points for total skills, cooperation and communication score. At the end of the session, learner immediate feedback were also collected using an online feedback form, which provided accountability for attendance, content learning, and course evaluation feedback.
- Being tested
- Simulation Training
- Keywords
- In Situ Simulation, Intreprofessional Training, High Fidelity Mannequin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation TrainingProcedure or surgery
Simulation Training using High and Low Fidelity Simulator
| Study group | Role | What they receive |
|---|---|---|
| High Fidelity Simulator | Active comparator | Subjects will receive training using high fidelity simulator Receives: Procedure: Simulation Training |
| Low Fidelity Simulator | Active comparator | Subjects will receive training using low fidelity simulator Receives: Procedure: Simulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of interprofessional communication
improvement of interprofessional communication in transferring critically ill COVID-19 patients
Measured: within 3 months
rate of skill
improvement of skill in transferring critically ill COVID-19 patients
Measured: within 3 months
rate of team work
improvement of team work in transferring critically ill COVID-19 patients
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start16 Nov 2020
- Primary completion19 Nov 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Simulation of Physical IllnessStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113823
- Sponsor's protocol ID
- IndonesiaUAnes122
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manggala SK, Tantri AR, Sugiarto A, Sianipar IR, Prasetyono TOH. In situ simulation training for a better interprofessional team performance in transferring critically ill patients with COVID-19: a prospective randomised control trial. Postgrad Med J. 2022 Aug;98(1162):617-621. doi: 10.1136/postgradmedj-2021-141426. Epub 2022 Jan 31.
PubMed 35101969
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Situ Simulation Training for a Better Interprofessional Team Performance in Transferring Critically Ill COVID-19 Patients: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05113823
- Acronym / sponsor ID
- IndonesiaUAnes122
- Keywords
- In Situ Simulation, Intreprofessional Training, High Fidelity Mannequin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 9 Nov 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 determine the role of in situ simulation training during a pandemic by using standard and high-fidelity mannequins to improve interprofessional communication, skills, and teamwork in transferring critically ill COVID-19 patients.
Detailed description
Fourty subjects were randomly allocated into two large groups, the High Fidelity Simulator group and the Low Fidelity Simulator group. Each group was divided into small groups, consist of 2 doctors and 3 nurses. All subjects underwent the same interactive lectures, and two sessions of in-situ simulation according to their assign group. In-situ simulation and debriefing were performed by implementing appropriate personal protective equipment and social distancing. At the end of each simulation session, each group would underwent a debriefing session, which was performed by an experience instructor. The first simulation was aimed to teach participants skills and steps in transporting critically-ill COVID-19 patients according to the hospital check-list. While the second simulation was aimed to assess skills, team work and communication that participants had learned from the previous simulation, by using assessment tools that had been developed before. In addition to comparing each point in the assessment tool between the two groups, the points that had been earned were also added up to get the overall points for total skills, cooperation and communication score. At the end of the session, learner immediate feedback were also collected using an online feedback form, which provided accountability for attendance, content learning, and course evaluation feedback.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Fidelity Simulator | Active comparator | Procedure: Simulation TrainingSubjects will receive training using high fidelity simulator |
| Low Fidelity Simulator | Active comparator | Procedure: Simulation TrainingSubjects will receive training using low fidelity simulator |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- in good physical condition
- had no history of involving in COVID-19 patients care
- willing to become study subject
Key exclusion criteria (1 listed)
- doesn't want to become study subject
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 TrainingSimulation Training using High and Low Fidelity Simulator | Procedure or surgery | High Fidelity Simulator, Low Fidelity Simulator |
Primary outcome
rate of interprofessional communication
Time frame: within 3 months
improvement of interprofessional communication in transferring critically ill COVID-19 patients
rate of skill
Time frame: within 3 months
improvement of skill in transferring critically ill COVID-19 patients
rate of team work
Time frame: within 3 months
improvement of team work in transferring critically ill COVID-19 patients
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 9 Nov 2021.
- Derived from this study: PubMed 35101969Manggala SK, Tantri AR, Sugiarto A, Sianipar IR, Prasetyono TOH. In situ simulation training for a better interprofessional team performance in transferring critically ill patients with COVID-19: a prospective randomised control trial. Postgrad Med J. 2022 Aug;98(1162):617-621. doi: 10.1136/postgradmedj-2021-141426. Epub 2022 Jan 31.
Related trials for Simulation of Physical Illness
Not yet recruiting
Moulage Technique in Child Abuse Recognition
Nursing Education, Simulation of Physical Illness
Active, not recruiting
Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population
Tracheostomy Complication, Simulation of Physical Illness
Recruiting
The Holographic Standardized Patient
Medical Emergencies, Educational Problems
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Simulation of Physical Illness and COVID-19 Respiratory Infection, 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 3 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 9 Nov 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?
rate of interprofessional communication (time frame: within 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05113823, which also lists 1 linked publication.
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 9 Nov 2021.