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Evaluation of the API-VIGIE Monitoring System: Program to Reduce Emergency Visits for Severe Paroxysmal Alcoholism (EVAL-APIVIGIE)

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ClinicalTrials.gov Identifier: NCT05173116
Recruitment Status : Withdrawn (protocol not implemented for logistical reasons in the recruiting center, possible rescheduling.)
First Posted : December 29, 2021
Last Update Posted : January 11, 2023
F2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health)
Information provided by (Responsible Party):
Centre Hospitalier Arras

Brief Summary:
The study was designed to evaluate the APIVIGIE program use at CH d'Arras. The objective of this program is to reduce repeated visits by the same patient to the emergency room for Alcoholism Severe Paroxysmal

Condition or disease Intervention/treatment
Intoxication;Alcohol;Acute Emergencies Other: Medical Outcomes Study Short Form 36 (SF 36) Other: observationnal study

Detailed Description:

In France, between 10% and 30% of emergency room admissions are linked to problematic alcohol consumption. This considerable weight of alcohol-related problems in the current problematic of emergencies is largely unknown and can lead to blockages in emergencies.

For acute intoxication requiring emergency care, 80% of admissions concern people dependent on alcohol. Here again, this crucial clinical notion is largely ignored: when a patient in a state of intoxication arrives in the emergency room, this should not be considered as a banal and one-off event, it is necessary to put in place a care, if necessary, of addiction.

Supported by a call for projects from the Hauts-de-France Regional Health Agency, the Addictions Service of the Arras Hospital is setting up a monitoring system called APIVIGIE.

APIVIGIE program is offered to patients who present to the emergency room for a diagnosis of API after an evaluation by the liaison team of the addiction service. If the patient agrees to be part of the program, he will receive a resource card with the APIVIGIE phone number to contact if necessary.

The link will be maintained with the Addictology Care, Support and Prevention Center (CSAPA) for a period of 6 months, by telephone consultations, or by video-consultations or face-to-face consultations.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Evaluation of API-VIGIE Monitoring System: Program to Reduce Emergency Visits for Severe Paroxysmal Alcoholism
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
prospective study
API-VIGIE program adult participant who agreed to participate in the study
Other: Medical Outcomes Study Short Form 36 (SF 36)
completion of questionnaire quality of life SF 36 (inclusion, Month 3, Month 6).

retrospective study
Any stay for adults patients in the emergency room of the ARRAS hospital for API during the period covered (from 1 year before to 1 year after the installation of the APIVIGIE program) (main diagnosis or associated with an API (F10.0 according to the ICD-10 classification used by Department of Medical Information)
Other: observationnal study
data collection

Primary Outcome Measures :
  1. Number of visits to the Emergency Reception Service for Significant Paroxysmal Alcoholics [ Time Frame: during 2 years ]
    1 year before implementation of the program and up to 1 year after implementation of the program

Secondary Outcome Measures :
  1. weekly consumption of alcoholic beverages [ Time Frame: Inclusion , Visit 2 (Month 3) and visit 3 (Month 6) ]
  2. weekly consumption of other substances (cannabis, other substances) [ Time Frame: Inclusion , Visit 2 (Month 3) and visit 3 (Month 6) ]
  3. Quality of life score, measured by the Medical Outcomes Study Short Form 36 (SF-36) health scale score. [ Time Frame: Inclusion , Visit 2 (Month 3) and visit 3 (Month 6) ]
    SF 36 giving a score from 0 to 100. More higher score, more better quality of life.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participant at API-VIGIE program

Inclusion Criteria:

  • Patient 18 years or older;
  • Participant at API-VIGIE program.

Exclusion Criteria:

  • Patient's opposition to participating in the research;
  • Persons under legal protection (under tutorship or curatorship);
  • Person deprived of liberty;
  • Pregnant or breastfeeding women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05173116

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Dominique LEJEUNE
Arras, France
Sponsors and Collaborators
Centre Hospitalier Arras
F2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health)
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Principal Investigator: Dominique LEJEUNE, M.D Centre Hospitalier Arras
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Responsible Party: Centre Hospitalier Arras
ClinicalTrials.gov Identifier: NCT05173116    
Other Study ID Numbers: 2020-08
First Posted: December 29, 2021    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Arras:
Addiction, Alcohol
binge drinking
young adult
Additional relevant MeSH terms:
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Alcoholic Intoxication
Disease Attributes
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders