Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison
SAMBA
3 other identifiers
interventional
73
1 country
26
Brief Summary
The SAMBA study aims to assess the safety and cost comparison of the management of outpatient alcohol detoxification, between an advanced nurse protocol on the one hand (experimental group), and a GP-based treatment on the other hand (standard-of-care group). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 13, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedJuly 12, 2022
February 1, 2019
4.1 years
February 13, 2017
July 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients considered in failure of outpatient alcohol detoxification period
Hospitalization required (any cause) across the 15 days following the detox start
15 days
Secondary Outcomes (4)
The total costs for each arm by cost-minimization
during the 15 days of the outpatient alcohol detoxification
Number of patients reporting at least one recovery in alcohol consumption
during the 15 days of the outpatient alcohol detoxification
Number of patients reporting at least one high alcohol intake
during the 15 days of the outpatient alcohol detoxification
Number of patients with adverse events
during the 15 days of the outpatient alcohol detoxification
Study Arms (2)
Advanced Nurse (AN)
EXPERIMENTALThe 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.
General Practitioner (GP)
ACTIVE COMPARATORThe outpatient detoxication procedure is entrusted to a GP who will manage patients and diazepam dosing as he/she thinks best ("as usual" control group)
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV-Tr criteria for alcohol dependence
- Clinical indication for alcohol detoxification
- Social Insurance
- Signed Consent Form for participation
You may not qualify if:
- Previous history of seizures
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Ministry of Health, Francecollaborator
Study Sites (26)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renaud JARDRI, MD, PhD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2017
First Posted
February 17, 2017
Study Start
January 1, 2017
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
July 12, 2022
Record last verified: 2019-02