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

NCT ID: NCT05552534

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2024-08-03

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.

Conditions

Tobacco Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

STIR PROTOCOL

Intervention Type: OTHER

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.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

STIR PROTOCOL

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.

Intervention Type: OTHER

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Laure Philippon, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Emergency department Hospital Pitié-Salpêtrière

Paris, , France

Countries

France

Other Identifiers

ID RCB 2021-A03003-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220066

Identifier Type: -

Identifier Source: org_study_id