The Impact of Brief Motivational Counseling for Smoking Cessation in an Italian Emergency Department: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Point prevalence of tobacco-free patients assessment
研究概览
简要总结
Smoke is still a significant Public Health problem. The Emergency Departments (EDs) could be the ideal setting to set up smoke cessation interventions (high prevalence of smoking patient compared to the general population). The structured brief counseling 5As based (ask, advice, asses, assist, arrange) is an effective Public Health intervention when performed by the General Practitioners. Still not clear is its feasibility and effectiveness in the ED setting. Aim of the study. To assess the feasibility and effectiveness of the 5As based counselling in the University ED of Novara compared to the "usual care".
详细描述
The study is a Randomized Controlled Trial performed in Novara (Piedmont, Italy) in the ED of the "Maggiore della Carità" University Hospital and involving the Treatment Center for Tobacco use (CTT) of the Addiction Department of the Local Health Unit of Novara (ASL NO).
The RCT has two parallel groups (allocation 1:1): the intervention group and the controll group.
Adult smokers attending ED of the "Maggiore della Carità" University Hospital of the city of Novara are invited to participate to the intervention.
The intervention consists in the "5As" smoke cessation brief structured counselling performed by the ED nurses. The 5As counselling is composed by 5 main steps:
- Ask: every patient is asked whether he/she is or is not a smoker in order to identify those who could benefit from the counseling;
- Advice: the patient is advised to quit in a strong, clear and personalized way;
- Assess: the patient is asked if he/she would like to quit and it is assessed the strength of his/her dependence in order to tailor the following step on the patient's situation and readiness to quit;
- Assist: all the patients receive the counseling by the nurse and those interested in quitting are assisted in their attempts. Furthermore patients are asked whether they want to be contacted by the CTT in order to start an intensive treatment;
- Arrange: for the patients willing to make a quit attempt, it is aimed to arrange for follow up contact by the CTT and to start a treatment in the CTT. It is expected also to prevent or treat eventual relapses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Patients do not know in which group they were randomized
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-statement as "current smokers" (at least one cigarette per day) during the triage interview;
- •age ≥ 18;
- •priority code urgency (yellow code) or deferrable urgency (green code) or non-urgency (white code);
- •provision of an informed consent.
排除标准
- •priority code emergency (red code);
- •altered mental status or history of psychiatric illness;
- •inability to understand either written or oral Italian;
- •patient already in treatment or follow-up for tobacco addiction;
- •patient allocated to a nurse who has not been trained in counseling and does not participate to the study;
- •informed consent denied
结局指标
主要结局
Point prevalence of tobacco-free patients assessment
时间窗: At 12 months from the intervention
Those who did not smoke in the last 7 days; dichotomous variable: yes/no. Better outcome: yes. Investigated by the ad-hoc telephone administrated questionnaire.
次要结局
- Continuous abstinence during the last 3 months assessment(At 12 months from the intervention)
- Decrease of at least 50% in daily tobacco use in the past 7 days with respect to baseline(At 12 months from the intervention)
- Point prevalence of tobacco-free patients assessment(At 6 months from the intervention)
- Transition in motivational stages(At 12 months from the intervention)
- Quit attempts number.(At 12 months from the intervention)
研究者
Fabrizio Faggiano
Professor
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"