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Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison (SAMBA)

Primary Purpose

Alcohol Dependence

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Advanced Nurse (AN)
General Practitioner (GP)
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Dependence focused on measuring Detoxification, Outpatient, Advanced Nursing, Health Services

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV-Tr criteria for alcohol dependence
  • Clinical indication for alcohol detoxification
  • Social Insurance
  • Signed Consent Form for participation

Exclusion Criteria:

  • 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

Sites / Locations

  • CH Beziers
  • CH Boulogne
  • CHU Brest
  • CHU Clermont-Ferrand
  • Csapa Anpaa63
  • CHU Créteil
  • CH Dunkerque
  • CHU Grenoble
  • CH Lens - CSAPA Le Square
  • CSAPA CHRU - Le PARI
  • CH Limoux
  • CSAPA Arc-en-Ciel
  • CHU Nancy
  • CHU Nantes
  • Les Apsyades
  • Centre LOGOS
  • CH Perpignan
  • Csapa Anpaa66
  • CH Roubaix
  • CSAPA La Trame - ANPAA59
  • CHU Rouen
  • CH du Rouvray
  • CH Alpes-Isère
  • CHU Strasbourg
  • CH Tourcoing
  • CH Troyes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Advanced Nurse (AN)

General Practitioner (GP)

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

Number of patients considered in failure of outpatient alcohol detoxification period
Hospitalization required (any cause) across the 15 days following the detox start

Secondary Outcome Measures

The total costs for each arm by cost-minimization
All medical costs (visits, medications, hospitalizations, ambulance,..) resulting from the detoxification management
Number of patients reporting at least one recovery in alcohol consumption
alcohol consumption obtained from A-TLFB data
Number of patients reporting at least one high alcohol intake
High alcohol intake defined by consumption of more than 5 standard drinks per day
Number of patients with adverse events

Full Information

First Posted
February 13, 2017
Last Updated
July 11, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT03056365
Brief Title
Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison
Acronym
SAMBA
Official Title
Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Detoxification, Outpatient, Advanced Nursing, Health Services

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Advanced Nurse (AN)
Arm Type
Experimental
Arm Description
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.
Arm Title
General Practitioner (GP)
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Advanced Nurse (AN)
Intervention Description
Protocoled AN-based management of detox
Intervention Type
Procedure
Intervention Name(s)
General Practitioner (GP)
Intervention Description
'As usual' medical management of detox
Primary Outcome Measure Information:
Title
Number of patients considered in failure of outpatient alcohol detoxification period
Description
Hospitalization required (any cause) across the 15 days following the detox start
Time Frame
15 days
Secondary Outcome Measure Information:
Title
The total costs for each arm by cost-minimization
Description
All medical costs (visits, medications, hospitalizations, ambulance,..) resulting from the detoxification management
Time Frame
during the 15 days of the outpatient alcohol detoxification
Title
Number of patients reporting at least one recovery in alcohol consumption
Description
alcohol consumption obtained from A-TLFB data
Time Frame
during the 15 days of the outpatient alcohol detoxification
Title
Number of patients reporting at least one high alcohol intake
Description
High alcohol intake defined by consumption of more than 5 standard drinks per day
Time Frame
during the 15 days of the outpatient alcohol detoxification
Title
Number of patients with adverse events
Time Frame
during the 15 days of the outpatient alcohol detoxification

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV-Tr criteria for alcohol dependence Clinical indication for alcohol detoxification Social Insurance Signed Consent Form for participation Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud JARDRI, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Beziers
City
Beziers
Country
France
Facility Name
CH Boulogne
City
Boulogne
Country
France
Facility Name
CHU Brest
City
Brest
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont Ferrand
Country
France
Facility Name
Csapa Anpaa63
City
Clermont Ferrand
Country
France
Facility Name
CHU Créteil
City
Creteil
Country
France
Facility Name
CH Dunkerque
City
Dunkerque
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
CH Lens - CSAPA Le Square
City
Lens
Country
France
Facility Name
CSAPA CHRU - Le PARI
City
Lille
Country
France
Facility Name
CH Limoux
City
Limoux
Country
France
Facility Name
CSAPA Arc-en-Ciel
City
Montpellier
Country
France
Facility Name
CHU Nancy
City
Nancy
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
Les Apsyades
City
Nantes
Country
France
Facility Name
Centre LOGOS
City
Nimes
Country
France
Facility Name
CH Perpignan
City
Perpignan
Country
France
Facility Name
Csapa Anpaa66
City
Perpignan
Country
France
Facility Name
CH Roubaix
City
Roubaix
Country
France
Facility Name
CSAPA La Trame - ANPAA59
City
Roubaix
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
CH du Rouvray
City
Rouvray
Country
France
Facility Name
CH Alpes-Isère
City
Saint-Egrève
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Facility Name
CH Tourcoing
City
Tourcoing
Country
France
Facility Name
CH Troyes
City
Troyes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison

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