ClinicalTrials.gg
WithdrawnNCT05173116EVAL-APIVIGIEUpdated Jan 11, 2023

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

An observational study in Intoxication;Alcohol;Acute and Emergencies, sponsored by Centre Hospitalier Arras. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-11.

Sponsored by Centre Hospitalier Arras · Observational

Why this study was withdrawn
protocol not implemented for logistical reasons in the recruiting center, possible rescheduling.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Intoxication;Alcohol;Acute
  • Emergencies

Keywords

  • Intoxication;Alcohol;Acute
  • Addiction, Alcohol
  • binge drinking
  • young adult
03

In context

Alcoholic Intoxication

76 studies on the registry are indexed under Alcoholic Intoxication; 17 are open to participants now.

Browse Alcoholic Intoxication studies →

Lead sponsor

Centre Hospitalier Arras is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participant at API-VIGIE program

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • prospective study

    API-VIGIE program adult participant who agreed to participate in the study

    Other: Medical Outcomes Study Short Form 36 (SF 36)

  • 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

Interventions

  • OtherMedical Outcomes Study Short Form 36 (SF 36)

    completion of questionnaire quality of life SF 36 (inclusion, Month 3, Month 6).

  • Otherobservationnal study

    data collection

06

What researchers measure

Primary outcomes

  1. Number of visits to the Emergency Reception Service for Significant Paroxysmal Alcoholics

    1 year before implementation of the program and up to 1 year after implementation of the program

    Time frame: during 2 years

Secondary outcomes

  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.

    SF 36 giving a score from 0 to 100. More higher score, more better quality of life.

    Time frame: Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)

07

Study locations

1 site
  • Dominique LEJEUNE
    Arras, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2022; primary completion for Feb 2023, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2021
First posted
Dec 29, 2021
StartEst.
Feb 2022
Primary completionEst.
Feb 2023
CompletionEst.
Aug 2023
Last update
Jan 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05173116
Lead sponsor
Centre Hospitalier Arras
Collaborators
F2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health)
Responsible party
Sponsor
First posted
Dec 29, 2021
Start date
Feb 2022 (estimated)
Primary completion
Feb 2023 (estimated)
Completion
Aug 2023 (estimated)
Last update
Jan 11, 2023

Study contacts

Dominique LEJEUNE, M.D
principal investigator · Centre Hospitalier Arras

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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