Intoxication;Alcohol;AcuteEVAL-APIVIGIENCT05173116
Evaluation of the API-VIGIE Monitoring System: Program to Reduce Emergency Visits for Severe Paroxysmal Alcoholism
An observational study of Intoxication;Alcohol;Acute and Emergencies, run by Centre Hospitalier Arras at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intoxication;Alcohol;Acute, Emergencies
- What is being tested?
- Medical Outcomes Study Short Form 36 (SF 36) and observationnal study
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant at API-VIGIE program
Who may be able to join
- Patient 18 years or older;
- Participant at API-VIGIE program.
Who cannot join
- Patient's opposition to participating in the research;
- Persons under legal protection (under tutorship or curatorship);
- Person deprived of liberty;
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Intoxication;Alcohol;Acute, Emergencies
- Being tested
- Medical Outcomes Study Short Form 36 (SF 36), observationnal study
- Keywords
- Intoxication;Alcohol;Acute, Addiction, Alcohol, binge drinking, young adult
- Medical subject headings
- Alcoholic Intoxication, Emergencies, Alcoholism, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Outcomes Study Short Form 36 (SF 36)Other
completion of questionnaire quality of life SF 36 (inclusion, Month 3, Month 6).
observationnal studyOther
data collection
| Study group | Role | What they receive |
|---|---|---|
| prospective study | API-VIGIE program adult participant who agreed to participate in the study Receives: 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) Receives: Other: observationnal study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during 2 years
Secondary outcomes (3)
weekly consumption of alcoholic beverages
Measured: Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)
weekly consumption of other substances (cannabis, other substances)
Measured: 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.
SF 36 giving a score from 0 to 100. More higher score, more better quality of life.
Measured: Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study startFeb 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: protocol not implemented for logistical reasons in the recruiting center, possible rescheduling.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intoxication;Alcohol;AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Arras
- Sponsor type
- University, hospital or other
- Collaborators
- F2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health)
- Responsible party
- Sponsor
- Investigators
- Dominique LEJEUNE, M.D, Principal investigator, Centre Hospitalier Arras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173116
- Sponsor's protocol ID
- 2020-08
- Acronym
- EVAL-APIVIGIE
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of API-VIGIE Monitoring System: Program to Reduce Emergency Visits for Severe Paroxysmal Alcoholism
- ClinicalTrials.gov ID
- NCT05173116
- Acronym / sponsor ID
- EVAL-APIVIGIE / 2020-08
- Conditions
- Intoxication;Alcohol;Acute, Emergencies
- Keywords
- Intoxication;Alcohol;Acute, Addiction, Alcohol, binge drinking, young adult
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: protocol not implemented for logistical reasons in the recruiting center, possible rescheduling.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier ArrasUniversity, hospital or other
- Collaborators
- F2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health)
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prospective study | – | Other: Medical Outcomes Study Short Form 36 (SF 36)API-VIGIE program adult participant who agreed to participate in the study |
| retrospective study | – | Other: observationnal studyAny 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant at API-VIGIE program
Key inclusion criteria (2 listed)
- Patient 18 years or older;
- Participant at API-VIGIE program.
Key exclusion criteria (4 listed)
- Patient's opposition to participating in the research;
- Persons under legal protection (under tutorship or curatorship);
- Person deprived of liberty;
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Outcomes Study Short Form 36 (SF 36)completion of questionnaire quality of life SF 36 (inclusion, Month 3, Month 6). | Other | prospective study |
| observationnal studydata collection | Other | retrospective study |
Primary outcome
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
3 secondary outcomes
weekly consumption of alcoholic beverages
Time frame: 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)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique LEJEUNE, M.D principal investigator
Centre Hospitalier Arras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intoxication;Alcohol;Acute and Emergencies, run by Centre Hospitalier Arras at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of visits to the Emergency Reception Service for Significant Paroxysmal Alcoholics (time frame: during 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.