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

Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs

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.

Study Overview

• Status: Terminated
• Conditions: Alcohol Dependence
• Intervention / Treatment: Procedure: Advanced Nurse (AN); Procedure: General Practitioner (GP)

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Beziers, France
    • Ch Beziers
  • Boulogne, France
    • CH Boulogne
  • Brest, France
    • CHU Brest
  • Clermont Ferrand, France
    • CHU Clermont-Ferrand
  • Clermont Ferrand, France
    • Csapa Anpaa63
  • Creteil, France
    • CHU CRETEIL
  • Dunkerque, France
    • Ch Dunkerque
  • Grenoble, France
    • CHU Grenoble
  • Lens, France
    • CH Lens - CSAPA Le Square
  • Lille, France
    • CSAPA CHRU - Le PARI
  • Limoux, France
    • CH Limoux
  • Montpellier, France
    • CSAPA Arc-en-Ciel
  • Nancy, France
    • CHU Nancy
  • Nantes, France
    • Chu Nantes
  • Nantes, France
    • Les Apsyades
  • Nimes, France
    • Centre LOGOS
  • Perpignan, France
    • CH Perpignan
  • Perpignan, France
    • Csapa Anpaa66
  • Roubaix, France
    • CH Roubaix
  • Roubaix, France
    • CSAPA La Trame - ANPAA59
  • Rouen, France
    • CHU Rouen
  • Rouvray, France
    • CH du Rouvray
  • Saint-Egrève, France
    • CH Alpes-Isère
  • Strasbourg, France
    • CHU Strasbourg
  • Tourcoing, France
    • Ch Tourcoing
  • Troyes, France
    • Ch Troyes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Advanced Nurse (AN); Protocoled AN-based management of detox
Active Comparator: 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)	Procedure: General Practitioner (GP); 'As usual' medical management of detox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total costs for each arm by cost-minimization	All medical costs (visits, medications, hospitalizations, ambulance,..) resulting from the detoxification management	during the 15 days of the outpatient alcohol detoxification
Number of patients reporting at least one recovery in alcohol consumption	alcohol consumption obtained from A-TLFB data	during the 15 days of the outpatient alcohol detoxification
Number of patients reporting at least one high alcohol intake	High alcohol intake defined by consumption of more than 5 standard drinks per day	during the 15 days of the outpatient alcohol detoxification
Number of patients with adverse events		during the 15 days of the outpatient alcohol detoxification

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Renaud Jardri, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Outpatient; Detoxification; Health Services; Advanced Nursing
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 2015_09; 2015-A01936-43 (Other Identifier: ID-RCB number, ANSM); PREPS_14-0209 (Other Identifier: PREPS number, DGOS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No