Alcohol Use DisorderAlcostopNCT04973202
Portrayal of Hospital Alcohol Detoxification in France
An observational study of Alcohol Use Disorder and Addiction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Even if hospital alcohol detoxifications are frequent in France, their caracteristicscharacteristics remain unknown. The investigators aim to describe the clinical and paraclinical caracteristicscharacteristics of their patients, their length and geographical repartition, etc… The investigators also aim to evaluate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Addiction, Alcohol Withdrawal Syndrome
- What is being tested?
- Stay for alcohol detoxification
- How many people
- 50,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 30 Aug 2021
- 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: French patients hospitalized for alcohol detoxification from 2011 to 2020
Who may be able to join
- French patients of at least 18 years old
- Inpatients of a public or private care facility for alcohol detoxification
- From 01/01/2011 to 12/31/2020
- In a medical or psychiatric hospital
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Portrayal of Hospital Alcohol Detoxifications and Factors Associated With Longer or Ulterior Hospitalizations in France From 2011 to 2020
Even if hospital alcohol detoxifications are frequent in France, their caracteristicscharacteristics remain unknown. The investigators aim to describe the clinical and paraclinical caracteristicscharacteristics of their patients, their length and geographical repartition, etc… The investigators also aim to evaluate factors associated with longer stays or ulterior re-hospitalization for the same reason. Finally, The investigators aim to compare the stays by facility type.
Read the detailed description
Context:
In France, the consequences of excessive alcohol use are one of the primary reasons for hospitalization. When stopping the substance, patients with an alcohol use disorder can suffer from a potentially fatal alcohol withdrawal syndrome. To mitigate these risks, a withdrawal under medical supervision is possible, either in an outpatient setting or in hospital, where the detoxification can be programmed or imposed. In the course of an alcohol dependent patient's life, re-drinking is not exceptional and the patient may undergo several withdrawals during his or her life.
Psychiatric pathologies, especially anxiety and depression, are more frequent in these patients than in the rest of the population, just as can be somatic pathologies.e. Withdrawal accidents, represented by comital seizures and delirium tremens, can be critical.
In hospital detoxifications, studies do not show any benefit in continuing the stay beyond 10 days, except in the case of somatic or psychiatric complication. However, little information is available on the average length of stay for hospital alcohol detoxification.
Although alcohol dependence issues are very frequent and the resulting withdrawals are relatively common and associated with numerous comorbidities, little data exists at a national level in France.
The aim of this study is to describe these hospital detoxifications: course, duration, frequency and clinical and paraclinical characteristics of the patients. We also wish to analyze which characteristics are associated with longer stays or re-hospitalization and to compare the care according to the facility type.
Objectives:
Main:
- To describe the clinical, paraclinical, and stay characteristics of hospital alcohol detoxification in France
Secondary:
- To describe the regional distribution of hospital alcohol detoxification
- To evaluate whether certain clinical characteristics are associated with a longer hospital stays
- To evaluate whether certain clinical characteristics are associated with subsequent re-hospitalization for the same reason
- To compare the characteristics of patient stays by type of facility
Methods:
In this descriptive observational study using pre-existing data accessed via the PMSI (Programme de Médicalisation des Systèmes d'Information), we will use all hospital stays from 2011 to 2020 for alcohol detoxification in France, both in public and private settings.
For each hospital stay will be collected the length, the antecedents of hospital alcohol detoxification, clinical and psychiatric comorbidities, withdrawals complication, alcohol use complication, further examinations.
We will describe the stays using median and quartiles for continuous variables and number and percentage for dichotomous variables. For secondary objectives, we will use a multivariate linear regression model if the length of stay is normal, an ordinal regression model otherwise. The characteristics of the stays will be compared regarding the type of facility using univariate comparative tests: Chi² or Fisher for dichotomous variables and Student or Mann-Whitney for continuous variables.
- Conditions
- Alcohol Use Disorder, Addiction, Alcohol Withdrawal Syndrome
- Being tested
- Stay for alcohol detoxification
- Keywords
- National portrayal of hospital alcohol detoxification in France, Rehabilitation in France, Alcohol in French hospitals and clinics, Alcohol detoxification
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stay for alcohol detoxificationOther
Stay for alcohol detoxification : routine care.
| Study group | Role | What they receive |
|---|---|---|
| Inpatients for alcohol detoxifications | French patients who were hospitalized for alcohol detoxification from 2011 to 2020 Receives: Other: Stay for alcohol detoxification |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of age
Age at admission (in years), calculated by the difference of the year of admission and the year of birth through the PMSI.
Measured: day 1 (At hospital inclusion)
description of sex
Sex collected through the PMSI.
Measured: day 1 (At hospital inclusion)
Secondary outcomes (9)
description of geographic code
Sex collected through the PMSI.
Measured: day 1 (At hospital inclusion)
description of CMU-C
CMU-C (universal complementary health insurance, collected through the PMSI.
Measured: day 1 (At hospital inclusion)
Length of stay
Length of stay (in days), calculated by the difference between the discharge date and the entry date, collected through the PMSI.
Measured: During the stay (day 1 - day 15)
Care establishment
Name and type of the care establishment, collected through the PMSI.
Measured: During the stay (day 1 - day 15)
Number of previous hospital detoxification stays in the studied period
Number of previous hospital detoxification stays in the studied period, collected through the PMSI.
Measured: During the stay (day 1 - day 15)
Psychiatric comorbidities
Psychiatric comorbidities (Major depression episode, anxiety, psychotic trouble, personality diseases), collected through the PMSI.
Measured: During the stay (day 1 - day 15)
Withdrawal complication
Withdrawal complications (delirium tremens, comitial seizures), collected through the PMSI.
Measured: During the stay (day 1 - day 15)
Further examination
Further examination (biology, imagery, etc…), collected through the PMSI.
Measured: During the stay (day 1 - day 15)
Re-hospitalization for same reason
For each patient, and each stay, we will evaluate if the patient had an ulterior re-hospitalization for alcohol withdrawal. Collected through the PMSI.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 May 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 50,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel MOULIS, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973202
- Sponsor's protocol ID
- RECHMPL21_0456
- Acronym
- Alcostop
- Status last verified
- Oct 2021
- First submitted
- 6 Jul 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portrayal of Hospital Alcohol Detoxifications and Factors Associated With Longer or Ulterior Hospitalizations in France From 2011 to 2020
- ClinicalTrials.gov ID
- NCT04973202
- Acronym / sponsor ID
- Alcostop / RECHMPL21_0456
- Conditions
- Alcohol Use Disorder, Addiction, Alcohol Withdrawal Syndrome
- Keywords
- National portrayal of hospital alcohol detoxification in France, Rehabilitation in France, Alcohol in French hospitals and clinics, Alcohol detoxification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 22 Jul 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.
Even if hospital alcohol detoxifications are frequent in France, their caracteristicscharacteristics remain unknown. The investigators aim to describe the clinical and paraclinical caracteristicscharacteristics of their patients, their length and geographical repartition, etc… The investigators also aim to evaluate factors associated with longer stays or ulterior re-hospitalization for the same reason. Finally, The investigators aim to compare the stays by facility type.
Detailed description
Context:
In France, the consequences of excessive alcohol use are one of the primary reasons for hospitalization. When stopping the substance, patients with an alcohol use disorder can suffer from a potentially fatal alcohol withdrawal syndrome. To mitigate these risks, a withdrawal under medical supervision is possible, either in an outpatient setting or in hospital, where the detoxification can be programmed or imposed. In the course of an alcohol dependent patient's life, re-drinking is not exceptional and the patient may undergo several withdrawals during his or her life.
Psychiatric pathologies, especially anxiety and depression, are more frequent in these patients than in the rest of the population, just as can be somatic pathologies.e. Withdrawal accidents, represented by comital seizures and delirium tremens, can be critical.
In hospital detoxifications, studies do not show any benefit in continuing the stay beyond 10 days, except in the case of somatic or psychiatric complication. However, little information is available on the average length of stay for hospital alcohol detoxification.
Although alcohol dependence issues are very frequent and the resulting withdrawals are relatively common and associated with numerous comorbidities, little data exists at a national level in France.
The aim of this study is to describe these hospital detoxifications: course, duration, frequency and clinical and paraclinical characteristics of the patients. We also wish to analyze which characteristics are associated with longer stays or re-hospitalization and to compare the care according to the facility type.
Objectives:
Main:
- To describe the clinical, paraclinical, and stay characteristics of hospital alcohol detoxification in France
Secondary:
- To describe the regional distribution of hospital alcohol detoxification
- To evaluate whether certain clinical characteristics are associated with a longer hospital stays
- To evaluate whether certain clinical characteristics are associated with subsequent re-hospitalization for the same reason
- To compare the characteristics of patient stays by type of facility
Methods:
In this descriptive observational study using pre-existing data accessed via the PMSI (Programme de Médicalisation des Systèmes d'Information), we will use all hospital stays from 2011 to 2020 for alcohol detoxification in France, both in public and private settings.
For each hospital stay will be collected the length, the antecedents of hospital alcohol detoxification, clinical and psychiatric comorbidities, withdrawals complication, alcohol use complication, further examinations.
We will describe the stays using median and quartiles for continuous variables and number and percentage for dichotomous variables. For secondary objectives, we will use a multivariate linear regression model if the length of stay is normal, an ordinal regression model otherwise. The characteristics of the stays will be compared regarding the type of facility using univariate comparative tests: Chi² or Fisher for dichotomous variables and Student or Mann-Whitney for continuous variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients for alcohol detoxifications | – | Other: Stay for alcohol detoxificationFrench patients who were hospitalized for alcohol detoxification from 2011 to 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- French patients hospitalized for alcohol detoxification from 2011 to 2020
Key inclusion criteria (4 listed)
- French patients of at least 18 years old
- Inpatients of a public or private care facility for alcohol detoxification
- From 01/01/2011 to 12/31/2020
- In a medical or psychiatric hospital
Key exclusion criteria (1 listed)
- age < 18 years
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 |
|---|---|---|
| Stay for alcohol detoxificationStay for alcohol detoxification : routine care. | Other | Inpatients for alcohol detoxifications |
Primary outcome
description of age
Time frame: day 1 (At hospital inclusion)
Age at admission (in years), calculated by the difference of the year of admission and the year of birth through the PMSI.
description of sex
Time frame: day 1 (At hospital inclusion)
Sex collected through the PMSI.
9 secondary outcomes
description of geographic code
Time frame: day 1 (At hospital inclusion)
description of CMU-C
Time frame: day 1 (At hospital inclusion)
Length of stay
Time frame: During the stay (day 1 - day 15)
Care establishment
Time frame: During the stay (day 1 - day 15)
Number of previous hospital detoxification stays in the studied period
Time frame: During the stay (day 1 - day 15)
Psychiatric comorbidities
Time frame: During the stay (day 1 - day 15)
Withdrawal complication
Time frame: During the stay (day 1 - day 15)
Further examination
Time frame: During the stay (day 1 - day 15)
Re-hospitalization for same reason
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Lionel MOULIS principal investigator
University Hospital, Montpellier
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 Alcohol Use Disorder and Addiction, run by University Hospital, Montpellier 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 19 Oct 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
description of age (time frame: day 1 (At hospital inclusion)). The study lists 2 primary outcomes in all. 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 19 Oct 2021.