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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01936-43 | Other Identifier | ID-RCB number, ANSM | |
| PREPS_14-0209 | Other Identifier | PREPS number, DGOS |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Nurse (AN) | Experimental | 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. |
|
| General Practitioner (GP) | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced Nurse (AN) | Procedure | Protocoled AN-based management of detox |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud JARDRI, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Beziers | Béziers | France | ||||
| CH Boulogne |
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| General Practitioner (GP) |
| Procedure |
'As usual' medical management of detox |
|
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 |
| 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 |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D058005 | General Practitioners |
| ID | Term |
|---|---|
| D010820 | Physicians |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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