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

January 9, 2023 updated by: Centre Hospitalier Arras

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Arras, France
        • Dominique LEJEUNE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participant at API-VIGIE program

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weekly consumption of alcoholic beverages
Time Frame: Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)
Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)
weekly consumption of other substances (cannabis, other substances)
Time Frame: Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)
Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)
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.
Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Arras

Collaborators

F2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health)

Investigators

  • Principal Investigator: Dominique LEJEUNE, M.D, Centre Hospitalier Arras

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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