Impact of an Intervention of Screening, Treatment Initiation and Referral to PROmote Smoking CEssation in Emergency Department Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Impact of an Intervention of Screening, Treatment Initiation and Referral to Promote Smoking Cessation in Emergency Department Patients: the Pilot PROSCEED Randomized Controlled Study

Conditions
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Tobacco Cessation

Intervention / Treatment
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* Other: STIR PROTOCOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Other: STIR PROTOCOL<br>* Screening, STIR protocol (screening, brief intervention, incentive to download the tobacco info service application, delivery of the tobacco-info-service brochure, initiation of a nicotine patch made by the 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and efficacy of a smoking cessation intervention | 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 | 3 months after emergency consultation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients who participated in consultations at D7 and M1 | Assessment of the patient circuit | Day 7 and 1 month after emergency consultation | 
| description of the procedure (duration of the inclusion) | Description of the research circuit | 4 months | 
| number of patients who refused to participate | Description of the procedure's barriers | 4 months | 
| Number of doctors/paramedics involved, and of staff who performed the follow-up | Description of staff involved | 4 months | 
| Feasibility of measuring exhaled carbon monoxide | Proportion of patients with a carbon monoxide measurement expired | 3 months after emergency consultation | 
| Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal |  | 3 months after emergency consultation | 
| Effectiveness of the smoking cessation intervention | Proportion of patients weaned at 7 days and at 1 month assessed, declarative, collected by phone | Day 7 and 1 month after emergency consultation | 
| Number of smoked cigarettes | Number of cigarettes smoked daily at 7 days, 1 and 3 months, declarative | Day 7, 1 month and 3 month after emergency consultation | 
| Patients' adherence to the intervention | - Questionnaire with Likert scale: In order to measure adherence to the intervention, 13 sentences in favor of the intervention : answers from 1. I strongly disagree to 5 . I completely agree. A higher score mean a better adherence (min: 13, max : 65). - Proportion of patients who completed follow-up consultations at 7 days and one month | 3 month after emergency consultation | 
| Emergency teams' adherence to the intervention | Questionnaire with Likert scale: In order to measure adherence to the intervention, 11 sentences in favor of the intervention : answers from 1. I strongly disagree to 5 . I completely agree. A higher score mean a better adherence (min: 11, max : 55). | 3 month after emergency consultation | 
| Patients ' adherence to the intervention, according to demographic criteria. | Description of the population according to age, gender, socio-economic characteristics, grounds for appeal | 3 month after emergency | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency medicine, Public Health, Addictionology, Smoking cessation, Tobacco dependence treatment