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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Procedure: Advanced Nurse (AN)
* Procedure: General Practitioner (GP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced Nurse (AN)<br>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)<br>* Protocoled AN-based management of detox<br>|
| Active Comparator: General Practitioner (GP)<br>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)<br>* 'As usual' medical management of detox<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Detoxification, Outpatient, Advanced Nursing, Health Services