Clinical trial NCT05552534: Impact of an Intervention of Screening, Treatment Initiation and Referral to PROmote Smoking CEssation in Emergency Department Patients
Official title: Impact of an Intervention of Screening, Treatment Initiation and Referral to Promote Smoking Cessation in Emergency Department Patients: the Pilot PROSCEED Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Cessation
Keywords: Emergency medicine
Public Health
Addictionology
Smoking cessation
Tobacco dependence treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

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

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

Primary outcomes:
measure: Feasibility and efficacy of a smoking cessation intervention
timeFrame: 3 months after emergency consultation
Secondary outcomes:
measure: proportion of patients who participated in consultations at D7 and M1
timeFrame: Day 7 and 1 month after emergency consultation
measure: description of the procedure (duration of the inclusion)
timeFrame: 4 months
measure: number of patients who refused to participate
timeFrame: 4 months
measure: Number of doctors/paramedics involved, and of staff who performed the follow-up
timeFrame: 4 months
measure: Feasibility of measuring exhaled carbon monoxide
timeFrame: 3 months after emergency consultation
measure: Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal
timeFrame: 3 months after emergency consultation
measure: Effectiveness of the smoking cessation intervention
timeFrame: Day 7 and 1 month after emergency consultation
measure: Number of smoked cigarettes
timeFrame: Day 7, 1 month and 3 month after emergency consultation
measure: Patients' adherence to the intervention
timeFrame: 3 month after emergency consultation
measure: Emergency teams' adherence to the intervention
timeFrame: 3 month after emergency consultation
measure: Patients ' adherence to the intervention, according to demographic criteria.
timeFrame: 3 month after emergency
Other outcomes:
Locations:
city: Paris
country: France
facility: Emergency department Hospital Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne Laure Philippon, MD
role: PRINCIPAL_INVESTIGATOR
References: