Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 73
- 试验地点
- 26
- 主要终点
- Number of patients considered in failure of outpatient alcohol detoxification period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV-Tr criteria for alcohol dependence
- •Clinical indication for alcohol detoxification
- •Social Insurance
- •Signed Consent Form for participation
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Advanced Nurse (AN) (Procedure)
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)
干预措施: General Practitioner (GP) (Procedure)
结局指标
主要结局
Number of patients considered in failure of outpatient alcohol detoxification period
时间窗: 15 days
Hospitalization required (any cause) across the 15 days following the detox start
次要结局
- Number of patients with adverse events(during the 15 days of the outpatient alcohol detoxification)
- The total costs for each arm by cost-minimization(during the 15 days of the outpatient alcohol detoxification)
- Number of patients reporting at least one recovery in alcohol consumption(during the 15 days of the outpatient alcohol detoxification)
- Number of patients reporting at least one high alcohol intake(during the 15 days of the outpatient alcohol detoxification)