Simulation of Physical IllnessNCT05648760
Simulation-based Training Improves Competency in Communicating Bad News
A study testing Simulation training in people with Simulation of Physical Illness, run by Southeast University, China at 1 site in China.
Trial summary
Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation of Physical Illness
- What is being tested?
- Simulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2022to Sep 2023
- 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
- Residents working at the Intensive Care Unit.
Who cannot join
- Residents who are are available for the intervention or who don't have the appropriate number of meetings captured for data analysis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda hospital
Nanjing, Jiangsu, 210000
Jingyyuan Xu, MD, 86-025-83262550, 13851417209@163.com
About this study
Official title: Simulation-based Training Improves Medical Student Competency in Communicating Bad News to Patients: A Randomized Controlled Trial
Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families.
Read the detailed description
Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The term "bad news" refers to any information transmitted to patients or their families that directly or indirectly involves a negative change in their lives or view of their future. Existing reports show that practicing doctors and residents lack confidence and skill in performing this task, and most have never received any formal training. Breaking bad news is a complex task requiring many skills including communication, responding to emotional reactions, and involving the family members.
The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families. We hypothesize that simulation-based training intervention will improve medical student competency in communicating bad news to patients.
- Conditions
- Simulation of Physical Illness
- Being tested
- Simulation training
- Keywords
- simulation, competency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation trainingBehavioural
Participants randomized to the simulation condition received simulation training based on a standard training of how to communicate bad news to patients
| Study group | Role | What they receive |
|---|---|---|
| Usual training | Other | Participants randomized to the control condition received a standard training of how to communicate bad news to patients Receives: Behavioral: Simulation training |
| Simulation training | Experimental | Participants randomized to the simulation training group received simulation training based on a standard training of how to communicate bad news to patients Receives: Behavioral: Simulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with competency in communicating bad news behavioral measure
Number of Participants with competency in communicating bad news behavioral measure
Measured: One month after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start12 Dec 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation of Physical IllnessStudies 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Jingyuan Xu, M.D., Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648760
- Sponsor's protocol ID
- 2022ZDYYLL01
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Training Improves Medical Student Competency in Communicating Bad News to Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05648760
- Acronym / sponsor ID
- 2022ZDYYLL01
- Conditions
- Simulation of Physical Illness
- Keywords
- simulation, competency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 13 Dec 2022 (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.
Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families.
Detailed description
Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The term "bad news" refers to any information transmitted to patients or their families that directly or indirectly involves a negative change in their lives or view of their future. Existing reports show that practicing doctors and residents lack confidence and skill in performing this task, and most have never received any formal training. Breaking bad news is a complex task requiring many skills including communication, responding to emotional reactions, and involving the family members.
The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families. We hypothesize that simulation-based training intervention will improve medical student competency in communicating bad news to patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual training | Other | Behavioral: Simulation trainingParticipants randomized to the control condition received a standard training of how to communicate bad news to patients |
| Simulation training | Experimental | Behavioral: Simulation trainingParticipants randomized to the simulation training group received simulation training based on a standard training of how to communicate bad news to patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents working at the Intensive Care Unit.
Key exclusion criteria (1 listed)
- Residents who are are available for the intervention or who don't have the appropriate number of meetings captured for data analysis
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 trainingParticipants randomized to the simulation condition received simulation training based on a standard training of how to communicate bad news to patients | Behavioural | Simulation training, Usual training |
Primary outcome
Number of Participants with competency in communicating bad news behavioral measure
Time frame: One month after training
Number of Participants with competency in communicating bad news behavioral measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- 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.
Jingyuan Xu, M.D. principal investigator
Southeast University
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, run by Southeast University, China at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingyuan Xu, M.D. (86-025-83262550, 13851417209@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with competency in communicating bad news behavioral measure (time frame: One month after training). 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 14 Dec 2022; AzTrials last refreshed its copy on 27 Oct 2026.