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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056365
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1262 participants
Allocation: Randomized
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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Number of patients with adverse events [ Time Frame: during the 15 days of the outpatient alcohol detoxification ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Benjamin ROLLAND, MD, PhD benjrolland@gmail.com
Contact: Aomar KEMKEM, CRA aomar.kemkem@chru-lille.fr

Locations
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Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Renaud JARDRI, MD, PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03056365    
Other Study ID Numbers: 2015_09
2015-A01936-43 ( Other Identifier: ID-RCB number, ANSM )
PREPS_14-0209 ( Other Identifier: PREPS number, DGOS )
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Detoxification
Outpatient
Advanced Nursing
Health Services
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders