NCT04726449

Brief Summary

Use of emergency department for psychiatric symptoms always addresses the question of a potential somatic cause to the symptoms. Despite the wide-spread use of standard biology test and systematic brain imaging (for a first episode), there are still up to 5% of patients sent in psychiatric wards that actually have a somatic explanation to their symptoms which induces an important delay in the diagnostic assessement We hypothesized that simple neurological clinical examination along with fast psychometric screening tests in the Emergency Room (ER) could help the physicians to better screen the patients and thus prevent inaccurate post-emergency orientation. Every patient visiting the ER for psychiatric symptoms will be included. The usual physical examination by the ER physician will be associated with two psychometric tests (namely the Clock-drawing test and Frontal Assessment Battery test). The follow up will be made after 3 months in order to have the final diagnosis. Neurological data and data from the FAB test and the Clock-drawing test will be compared between patients who were finally given a psychiatric diagnosis versus patients with a somatic diagnosis at the end of the follow up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 11, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2024

Completed
Last Updated

June 7, 2024

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

January 22, 2021

Last Update Submit

June 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Somatic or psychiatric nature of the final diagnosis given to the patient

    interview patient to collect during the last 90 days the data of a hospitalization, its possible duration, the examinations that may have been necessary to obtain the diagnosis: blood, urine, Cerebrospinal Fluid, imaging exams, electroencephalography.

    At 3 month

Study Arms (2)

psychiatric diagnosis

psychiatric diagnosis : patients who were given a psychiatric diagnosis at the end of the follow up

Other: Screening for acute confusional state

somatic diagnosis

somatic diagnosis: patients who were given a somatic diagnosis at the end of the follow up

Other: Screening for acute confusional state

Interventions

The intervention will consist of two psychometric test to screen for acute confusional state with the usual physical examination by the emergency physician. The neurological examination abnormalities will be noted

psychiatric diagnosissomatic diagnosis

Eligibility Criteria

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

Patient using emergency department for a psychiatric symptom

You may qualify if:

  • Age\> 18 years old
  • Patient consulting the emergency room for psychiatric recourse
  • Benefiting from a consultation with a psychiatrist in the emergency room
  • Patient affiliated to a social security scheme

You may not qualify if:

  • Pregnant or breastfeeding women
  • Patient objecting to the conduct of this study and the collection of health data
  • Patient with motor disorders preventing the performance of a test requiring a pencil
  • Patient sedated before treatment in the emergency room
  • Patient with visual disturbances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Accueil des Urgences, Hopital Edouard Herriot

Lyon, Rhône, 69003, France

Location

MeSH Terms

Conditions

Nervous System DiseasesMental Disorders

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • KARIM TAZAROURTE, MD, PhD

    Hôpital Edouard Herriot, HCL

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 27, 2021

Study Start

May 11, 2021

Primary Completion

May 8, 2024

Study Completion

May 8, 2024

Last Updated

June 7, 2024

Record last verified: 2023-07

Locations