Mass-casualty Incident PreparednessDEBRIEF-TNCT07889037
Structured Debriefing and Institutional Trust After a Mass-Casualty Simulation
A study testing Standard debriefing (PEARLS Method) and Standard debriefing (PEARLS Method) + support module in people with Mass-casualty Incident Preparedness, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mass-casualty Incident Preparedness
- What is being tested?
- Standard debriefing (PEARLS Method) and Standard debriefing (PEARLS Method) + support module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult hospital professional with an operational role during the exercise
- study information received
- voluntary agreement to participate
Who cannot join
- actors or standardized patients playing victims
- evaluators, organizers, or facilitators without an operational role in the scenario
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Beaujon
Clichy, 92110
Myriam Lamamri, MD, 33140888773, dorssaf.lamamri@aphp.fr
About this study
Official title: Impact of a Structured Post-Simulation Debriefing on Institutional Trust After a Mass-Casualty Incident Exercise: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Mass-casualty Incident Preparedness
- Being tested
- Standard debriefing (PEARLS Method), Standard debriefing (PEARLS Method) + support module
- Keywords
- Mass-casualty simulation, debriefing, institutional trust
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard debriefing (PEARLS Method)Other
Standardized debriefing using the PEARLS method without a specific psychological-support component.
Standard debriefing (PEARLS Method) + support moduleOther
Standardized debriefing using the PEARLS method with a specific psychological-support component.
| Study group | Role | What they receive |
|---|---|---|
| Standard debriefing (PEARLS Method) | Active comparator | Standardized debriefing using the PEARLS method without the specific psychological-support component. Receives: Other: Standard debriefing (PEARLS Method) |
| Standard debriefing (PEARLS Method) + support module | Experimental | Standardized debriefing using the PEARLS method with the specific psychological-support component developed by psychologist Receives: Other: Standard debriefing (PEARLS Method) + support module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after debriefing (T2)
Secondary outcomes (3)
Psychological safety score
Psychological safety assessed using the 6-item SCORE Psychological Safety Scale.
Measured: 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
Measured: 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
Measured: immediately after debriefing (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mass-casualty Incident PreparednessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myriam Lamamri, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889037
- Sponsor's protocol ID
- Amavi-RCT-2026
- Acronym
- DEBRIEF-T
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Structured Post-Simulation Debriefing on Institutional Trust After a Mass-Casualty Incident Exercise: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07889037
- Acronym / sponsor ID
- DEBRIEF-T / Amavi-RCT-2026
- Conditions
- Mass-casualty Incident Preparedness
- Keywords
- Mass-casualty simulation, debriefing, institutional trust
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 22 Oct 2026 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard debriefing (PEARLS Method) | Active comparator | Other: Standard debriefing (PEARLS Method)Standardized debriefing using the PEARLS method without the specific psychological-support component. |
| Standard debriefing (PEARLS Method) + support module | Experimental | Other: Standard debriefing (PEARLS Method) + support moduleStandardized debriefing using the PEARLS method with the specific psychological-support component developed by psychologist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult hospital professional with an operational role during the exercise
- study information received
- voluntary agreement to participate
Key exclusion criteria (3 listed)
- actors or standardized patients playing victims
- evaluators, organizers, or facilitators without an operational role in the scenario
- refusal to participate in the study
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 |
|---|---|---|
| Standard debriefing (PEARLS Method)Standardized debriefing using the PEARLS method without a specific psychological-support component. | Other | Standard debriefing (PEARLS Method) |
| Standard debriefing (PEARLS Method) + support moduleStandardized debriefing using the PEARLS method with a specific psychological-support component. | Other | Standard debriefing (PEARLS Method) + support module |
Primary outcome
Institutional confidence score
Time frame: Immediately after debriefing (T2)
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.
3 secondary outcomes
Psychological safety score
Time frame: immediately after debriefing (T2)
Willingness to participate in a future mass casualty response
Time frame: immediately after debriefing (T2)
State-Trait Anxiety Inventory
Time frame: immediately after debriefing (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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.
Myriam Lamamri, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard debriefing (PEARLS Method) and Standard debriefing (PEARLS Method) + support module in people with Mass-casualty Incident Preparedness, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 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: opening soon, as of the sponsor's last update on 22 Oct 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myriam Lamamri, MD (33140888773, dorssaf.lamamri@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Institutional confidence score (time frame: Immediately after debriefing (T2)). 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 22 Oct 2026.