Impact of an Intervention of Screening, Treatment Initiation and Referral to Promote Smoking Cessation in Emergency Department Patients: the Pilot PROSCEED Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Feasibility and efficacy of a smoking cessation intervention
研究概览
简要总结
Smoking cessation assistance is one of the major issues in prevention policies because the prevalence of smoking remains high in France. With its numerous consultations, an emergency service seems to be an interesting place for setting up and helping with weaning, despite specific working conditions. The study, which is a pilot, is interested in the feasibility and efficacy of the implementation of a STIR (Screening, Treatment Intervention and Referral) protocol, which screening, brief intervention, nicotine replacement therapy and referral to a specialist in order to help the patients in smoking cessation.
详细描述
Individual randomization as soon as the patient gives his consent and meets the inclusion - non-inclusion criteria.
Control group: delivery of the "tobacco-info-service" brochure titled "Why quit smoking? ", then phone call at 7 days and a month to collect tobacco consumption. Visit for 3 month. Intervention group: STIR protocol (screening, brief intervention, incentive to download the tobacco info service application, delivery of the "tobacco-info-service" brochure, initiation of a nicotine replacement therapy with nicotine patches made by a trained emergency nurse or doctor, then three consultations face-to-face or remotely with a member of the team addictionology at 7 days, 1 and 3 months.
In both groups: collection of the primary endpoint during the M3 visit. For patients who did not come (regardless of the group):
call for collection of the main judgment criterion
Carers will be included and will sign a consent form once the eligibility criteria have been checked and consent has been signed. They will be asked to complete an adherence questionnaire (Likert scale) regarding smoking prevention in emergency departments before the start of the study and after the last patient follow-up has taken place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= to 18 years old
- •Active smoker defined by having smoked at least 100 cigarettes in total in his life, associated with daily consumption or weekly
- •Free and informed consent signed by the patient
- •Patient with an understanding of the French language to participate in the intervention if necessary
- •Patient affiliated to a social security regimen
- •Care giver inclusion criteria:
- •Age ≥ 18 years
- •Caregiver working in one of the 3 departments participating in the study
- •Signature of free and informed consent
排除标准
- •Absolute vital emergency
- •Pregnant or breastfeeding women
- •Contraindication to taking nicotine
- •Taking nicotine by patch or gum or e-cigarette
- •Patient under AME (national medical insurance)
- •Patients under guardianship
结局指标
主要结局
Feasibility and efficacy of a smoking cessation intervention
时间窗: 3 months after emergency consultation
Composite outcome: Proportion of patients who participated in follow-up consultations at 3 months after going to the emergency room and proportion of patients weaned from smoking at three months in the intervention group, compared to the control group. A patient is said to be weaned if he / she declares having stopped smoking for 7 days 3 months after his / her visit to the emergency room
次要结局
- description of the procedure (duration of the inclusion)(4 months)
- number of patients who refused to participate(4 months)
- Number of doctors/paramedics involved, and of staff who performed the follow-up(4 months)
- Emergency teams' adherence to the intervention(3 month after emergency consultation)
- Patients ' adherence to the intervention, according to demographic criteria.(3 month after emergency)
- Feasibility of measuring exhaled carbon monoxide(3 months after emergency consultation)
- Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal(3 months after emergency consultation)
- Patients' adherence to the intervention(3 month after emergency consultation)
- Number of smoked cigarettes(Day 7, 1 month and 3 month after emergency consultation)
- proportion of patients who participated in consultations at D7 and M1(Day 7 and 1 month after emergency consultation)
- Effectiveness of the smoking cessation intervention(Day 7 and 1 month after emergency consultation)