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

• ClinicalTrials.gov Identifier: NCT03056365
• Recruitment Status: Unknown
• First Posted: February 17, 2017
• Last Update Posted: February 15, 2019
• Sponsor: University Hospital, Lille
• Collaborator: Ministry of Health, France
• Information provided by (Responsible Party): University Hospital, Lille

Tracking Information

• First Submitted Date: February 13, 2017
• First Posted Date: February 17, 2017
• Last Update Posted Date: February 15, 2019
• Actual Study Start Date: January 1, 2017
• Estimated Primary Completion Date: February 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Alcohol Dependence

Intervention

• Procedure: Advanced Nurse (AN)
  Protocoled AN-based management of detox
• Procedure: General Practitioner (GP)
  'As usual' medical management of detox

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 16, 2017): 1262
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2021
• Estimated Primary Completion Date: February 1, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03056365
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: University Hospital, Lille
• Study Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France

Investigators

• Principal Investigator: Renaud JARDRI, MD, PhD; University Hospital, Lille

• PRS Account: University Hospital, Lille
• Verification Date: February 2019