Trials / Terminated
TerminatedNCT03056365
Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison
Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Advanced Nurse (AN) | Protocoled AN-based management of detox |
| PROCEDURE | General Practitioner (GP) | 'As usual' medical management of detox |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2021-02-01
- Completion
- 2021-02-01
- First posted
- 2017-02-17
- Last updated
- 2022-07-12
Locations
26 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03056365. Inclusion in this directory is not an endorsement.