An interventional study of Standard debriefing (PEARLS Method) and Standard debriefing (PEARLS Method) + support module in Mass-casualty Incident Preparedness, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Health services research
This single-center, randomized, parallel-group trial evaluates whether adding a structured psychological and organizational support module to the standard technical debriefing via the PEARLS method after a full-scale hospital mass-casualty incident simulation increases healthcare professionals' confidence in their institution's ability to respond to a mass-casualty incident. Adult hospital professionals with an operational role in the exercise will complete a baseline questionnaire immediately after the exercise and before allocation. Participants will then be randomized 1:1 to standard debriefing control module or to standard debriefing plus a structured psychological and organizational support module. The primary outcome is the post-debriefing institutional confidence score, calculated as the mean of three 7-point Likert items and analyzed with adjustment for the pre-debriefing score.
All participants will take part in the same full-scale hospital exercise, which is organized independently of the research. Immediately after the exercise and before allocation (T1), participants will complete the three institutional-confidence items. Individual randomization will then be performed 1:1 using a computer-generated sequence with concealed allocation. Both groups will receive the same standardized technical/factual debriefing. The control group will additionally receive a duration-matched factual and organizational module without a specific psychological-support component. The intervention group will receive a structured module including non-pathologizing recognition and normalization of stress reactions, staff safety and support, transparent institutional communication, protection of personnel, available support resources, and explanation of how difficulties identified during the exercise will inform improvement of the exercise plan. The primary endpoint is the institutional confidence score immediately after debriefing (T2), defined as the unweighted mean of three 7-point Likert items covering preparedness, institutional honesty and acting in professionals' interests. The primary analysis will use a linear model/ANCOVA with T2 score as the dependent variable, randomized group as the main factor and T1 score as a covariate. Secondary outcomes include psychological safety, perceived organizational support, willingness to participate in a future real response, and debriefing acceptability/usefulness/tolerability. Debriefing quality and fidelity will be documented using the Debriefing Assessment for Simulation in Healthcare (DASH). The target is to randomize all participants to obtain approximately 50 analyzable responses. No patient data, medication, biological sample or medical procedure is involved. The DASH will be used as a process measure to assess the quality and fidelity of debriefing delivery. DASH scores will be reported to document whether the overall quality of debriefing was comparable between the standard debriefing group and the standard debriefing plus structured psychological and organizational support module group.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
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Exclusion Criteria:
Standardized debriefing using the PEARLS method without the specific psychological-support component.
Other: Standard debriefing (PEARLS Method)
Standardized debriefing using the PEARLS method with the specific psychological-support component developed by psychologist
Other: Standard debriefing (PEARLS Method) + support module
Standardized debriefing using the PEARLS method without a specific psychological-support component.
Standardized debriefing using the PEARLS method with a specific psychological-support component.
Institutional confidence score
Unweighted mean of three 7-point Likert items (1=strongly disagree to 7=strongly agree) assessing perceived hospital preparedness for an AMAVI, institutional honesty toward professionals, and the belief that the hospital would act in professionals' interests.
Time frame: Immediately after debriefing (T2)
Psychological safety score
Psychological safety assessed using the 6-item SCORE Psychological Safety Scale.
Time frame: immediately after debriefing (T2)
Willingness to participate in a future mass casualty response
Self-reported willingness to participate in the response to a future real mass-casualty incident, measured on a 1-to-7 Likert scale
Time frame: immediately after debriefing (T2)
State-Trait Anxiety Inventory
A validated 20-item self-report questionnaire assessing current state anxiety. Each item is rated on a 4-point Likert scale (1 to 4), with positively worded items reverse-scored as appropriate. Item scores are summed to obtain a total score ranging from 20 to 80, with higher scores indicating greater state anxiety
Time frame: immediately after debriefing (T2)
Plan to share: No
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Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.
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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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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