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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
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison
Official Title  ICMJE Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • Procedure: Advanced Nurse (AN)
    Protocoled AN-based management of detox
  • Procedure: General Practitioner (GP)
    'As usual' medical management of detox
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Advanced Nurse (AN)
  • 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)
    Intervention: Procedure: General Practitioner (GP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 16, 2017)
1262
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056365
Other Study ID Numbers  ICMJE 2015_09
2015-A01936-43 ( Other Identifier: ID-RCB number, ANSM )
PREPS_14-0209 ( Other Identifier: PREPS number, DGOS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Renaud JARDRI, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP