An interventional study of Coach-assisted simulation training in Wounds and Injuries, Clinical Decision-Making and Simulation Training, sponsored by Harvard Medical School (HMS and HSDM). Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Harvard Medical School (HMS and HSDM) · Not applicable, Interventional, and Health services research
The goal of this study is to learn whether simulation training with an ambient artificial-intelligence (AI) coach improves how physicians lead trauma resuscitations. The main question it aims to answer is:
- After coach-assisted training, do participants lead simulated trauma resuscitations without the coach better than they did before training?
Researchers will compare each participant's performance on cases led without the coach before and after training.
Participants will:
Blinded attending physicians score each case from a recording.
Participants lead simulated trauma resuscitations by voice as the trauma team leader. A computer simulation plays the patient and the trauma-bay team. The ambient AI coach listens to the simulated bay and shows decision-support cards on a dashboard; it does not speak or change the simulation. Performance on cases led without the coach is scored by blinded attending physicians.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 10 is below the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Harvard Medical School (HMS and HSDM) is the lead sponsor of 55 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Has previously led a trauma resuscitation as team leader
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants lead simulated trauma cases without the coach (baseline), training cases with the AI coach visible, and further cases without the coach (post-training).
Behavioral: Coach-assisted simulation training
Simulated trauma resuscitations led by voice with an ambient AI coach that shows real-time decision-support cards on a dashboard.
Change in Unassisted Team-Leader Performance Score From Baseline to Post-Training
Team-leader performance form with 4 items (critical actions and commands; prioritization and timeliness; diagnostic workup; leadership and communication), each scored from 1 to 5 by blinded attending reviewers; higher scores mean better performance. The per-case score is the mean of the 4 items. The outcome is the change in each participant's mean score from the baseline cases to the post-training cases.
Time frame: Baseline and post-training (within 8 weeks of baseline)
Mean Simulation Realism Score on a 4-Item Realism Form
Simulation-realism form with 4 items (clinical trajectory; patient response and findings; team and environment; decision pressure and complexity), each scored from 1 to 5 (higher means more realistic), completed by participants and by attending reviewers.
Time frame: After each scored case, at baseline and post-training (within 8 weeks of baseline)
Change in Self-Reported Preparedness Score on a 4-Item Confidence Form
Preparedness form with 4 items, each rated from 1 (not at all confident) to 5 (very confident), completed by participants before the first study case and after the last; reported as the change from before to after.
Time frame: Before the first study case and after the last study case (within 8 weeks)
Plan to share: Yes — De-identified participant-level data underlying the reported results will be available to researchers on reasonable request to the corresponding author after publication, under a data use agreement.
Supporting information: Statistical analysis plan
Time frame: Beginning with publication of the primary results.
Access criteria: Researchers who submit a reasonable request to the corresponding author; data are shared under a data use agreement.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
Of 546 non-industry interventional studies with no phase under Wounds and Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 3 months is below that.
Counting every sponsor, half of 599 studies reached it within 24 months; a quarter within 9 and three quarters within 48.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Harvard Medical School (HMS and HSDM)