Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison
NCT ID: NCT03056365
Last Updated: 2022-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
73 participants
INTERVENTIONAL
2017-01-01
2021-02-01
Brief Summary
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In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores, which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. In case of any serious adverse event or uncontrolled withdrawal complication, an addiction specialist stands in back-up and can be appealed to decide whether the outpatient detox can be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage patients as they wish.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Advanced Nurse (AN)
The outpatient detoxication procedure will be entirely managed by an advanced nurse team, using a predefined protocol decision algorithm. The protocol allows that the AN team autonomously manages the diazepam dosing during the detox period. Addiction physicians only intervenes in case of severe withdrawal symptoms or serious adverse events.
Advanced Nurse (AN)
Protocoled AN-based management of detox
General Practitioner (GP)
The outpatient detoxication procedure is entrusted to a GP who will manage patients and diazepam dosing as he/she thinks best ("as usual" control group)
General Practitioner (GP)
'As usual' medical management of detox
Interventions
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Advanced Nurse (AN)
Protocoled AN-based management of detox
General Practitioner (GP)
'As usual' medical management of detox
Eligibility Criteria
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Inclusion Criteria
* Clinical indication for alcohol detoxification
* Social Insurance
* Signed Consent Form for participation
Exclusion Criteria
* previous history of delirium tremens
* acute or chronic liver failure
* contraindication for using diazepam
* average daily alcohol use of 300g of ethanol
* SADQ score of 30 or more
* chronic treatment with baclofen or disulfiram
* current DMS-IV-Tr criteria for major depressive episode, or lifelong history of bipolar or psychotic disorder
* any physical, cognitive, or psychiatric disorder that expose the subjects to enhanced risks (at the discretion of the investigator)
* previous participation in the SAMBA study
* social isolation of homelessness (at the discretion of the investigator)
* pregnancy or breastfeeding
* guardianship or curatorship
* previous participation in a biomedical study over the previous month
18 Years
64 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Renaud JARDRI, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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CH Beziers
Béziers, , France
CH Boulogne
Boulogne, , France
CHU Brest
Brest, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Csapa Anpaa63
Clermont-Ferrand, , France
CHU Créteil
Créteil, , France
CH Dunkerque
Dunkirk, , France
CHU Grenoble
Grenoble, , France
CH Lens - CSAPA Le Square
Lens, , France
CSAPA CHRU - Le PARI
Lille, , France
CH Limoux
Limoux, , France
CSAPA Arc-en-Ciel
Montpellier, , France
CHU Nancy
Nancy, , France
CHU Nantes
Nantes, , France
Les Apsyades
Nantes, , France
Centre LOGOS
Nîmes, , France
CH Perpignan
Perpignan, , France
Csapa Anpaa66
Perpignan, , France
CH Roubaix
Roubaix, , France
CSAPA La Trame - ANPAA59
Roubaix, , France
CHU Rouen
Rouen, , France
CH du Rouvray
Rouvray, , France
CH Alpes-Isère
Saint-Egrève, , France
CHU Strasbourg
Strasbourg, , France
CH Tourcoing
Tourcoing, , France
CH Troyes
Troyes, , France
Countries
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Other Identifiers
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2015-A01936-43
Identifier Type: OTHER
Identifier Source: secondary_id
PREPS_14-0209
Identifier Type: OTHER
Identifier Source: secondary_id
2015_09
Identifier Type: -
Identifier Source: org_study_id
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