Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison (SAMBA)
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|ClinicalTrials.gov Identifier: NCT03056365|
Recruitment Status : Unknown
Verified February 2019 by University Hospital, Lille.
Recruitment status was: Recruiting
First Posted : February 17, 2017
Last Update Posted : February 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Procedure: Advanced Nurse (AN) Procedure: General Practitioner (GP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1262 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2021|
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
- Number of patients considered in failure of outpatient alcohol detoxification period [ Time Frame: 15 days ]Hospitalization required (any cause) across the 15 days following the detox start
- The total costs for each arm by cost-minimization [ Time Frame: during the 15 days of the outpatient alcohol detoxification ]All medical costs (visits, medications, hospitalizations, ambulance,..) resulting from the detoxification management
- Number of patients reporting at least one recovery in alcohol consumption [ Time Frame: during the 15 days of the outpatient alcohol detoxification ]alcohol consumption obtained from A-TLFB data
- Number of patients reporting at least one high alcohol intake [ Time Frame: during the 15 days of the outpatient alcohol detoxification ]High alcohol intake defined by consumption of more than 5 standard drinks per day
- Number of patients with adverse events [ Time Frame: during the 15 days of the outpatient alcohol detoxification ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056365
|Contact: Benjamin ROLLAND, MD, PhDfirstname.lastname@example.org|
|Contact: Aomar KEMKEM, CRAemail@example.com|
|Principal Investigator:||Renaud JARDRI, MD, PhD||University Hospital, Lille|