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

University Hospital, Lille

Status: Terminated

Conditions: Alcohol Dependence

Treatments: Procedure: General Practitioner (GP); Procedure: Advanced Nurse (AN)

Study type: Interventional

Funder types: Other

Identifiers

NCT03056365

2015-A01936-43 (Other Identifier)

PREPS_14-0209 (Other Identifier)

2015_09

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Advanced Nurse (AN)

Experimental group

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.

Treatment:

Procedure: Advanced Nurse (AN)

General Practitioner (GP)

Active Comparator group

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)

Treatment:

Procedure: General Practitioner (GP)