NCT06755606

Brief Summary

Post-traumatic stress disorder (PTSD) is a psychological disorder characterized by the re-experiencing of distressing symptoms, avoidance of traumatic memories and physiological hyperarousal in people who have been exposed to a traumatic event. The consequences of PTSD are manifold: financial, quality of life, absenteeism, morbidity, and mortality. An emergency department visit can be a traumatic event and associated with anxiety. Studies have explored the prevalence and factors associated with the occurrence of PTSD among a selected population of patients admitted to the emergency department for either cardiological or traumatological reasons. The prevalence of PTSD at 1 month varied among these populations, from 12% to 25%. Several factors have been described that could be independently associated with an increased risk of developing PTSD: factors linked to the patient himself (basal state and severity of acute pathology) or to the patient pathway (care structure, care modalities, waiting time). Given the serious medical, psycho-social and economic consequences of PTSD, it is important to identify the risk factors that can be controlled during a patient's stay in the emergency department. In 2025, a general information procedure for patients and next of kin will be deployed in three emergency departments. The aim of this procedure is to improve the quality of the information provided to emergency patients, thereby enhancing the experience of patients and those accompanying them. It will consist of video support delivering standardized information to patients from the moment they arrive in the emergency department until they are discharged. These videos will describe the patient's journey through the emergency department. The aim of this study is to evaluate the effect of this information procedure on the risk of developing PTSD.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

December 24, 2024

Last Update Submit

December 24, 2024

Conditions

Keywords

stress disordersinterventionscommunicationemergency medicine

Outcome Measures

Primary Outcomes (1)

  • Occurence PTSD

    assessed by calculation of PCL-5 score

    DaAy 30

Secondary Outcomes (2)

  • Identify factors associated with the occurrence of PTSD

    Day 30

  • HAD score at D30

    Day 30

Study Arms (2)

BEFORE

Group pf patients enrolled Before the information procedure was set up

AFTER

Group pf patients enrolled After the information procedure was set up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any adult patient coming for an unscheduled emergency consultation

You may qualify if:

  • Age ≥ 18 years
  • Triage level 1, 2, 3 by the triage nurse (according to CIMU, FRENCH or other scale used locally)
  • Non-opposition to participation in the study after information and delivery of the information note
  • Possibility of 30-day follow-up (self-questionnaire to be completed by e-mail)
  • Patient with cognitive or sensory capacity to view and understand information videos

You may not qualify if:

  • Inability to consent (neurological disorder, coma, acute intoxication, cognitive impairment)
  • Patient does not have a good understanding of the French language.
  • Estimated life expectancy less than 6 months
  • Participation in other clinical intervention research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Combat DisordersStress Disorders, Post-TraumaticStress Disorders, TraumaticCommunication

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersBehavior

Study Officials

  • Jennifer TRUCHOT, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer TRUCHOT, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 1, 2025

Study Start

February 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 1, 2025

Record last verified: 2024-12