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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05552534
Acronym
PROSCEED
Enrollment
152
Registered
2022-09-23
Start date
2022-11-03
Completion date
2024-08-03
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Cessation

Keywords

Emergency medicine, Public Health, Addictionology, Smoking cessation, Tobacco dependence treatment

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.

Interventions

OTHERSTIR 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and efficacy of a smoking cessation intervention3 months after emergency consultationComposite 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

Secondary

MeasureTime frameDescription
description of the procedure (duration of the inclusion)4 monthsDescription of the research circuit
number of patients who refused to participate4 monthsDescription of the procedure's barriers
Number of doctors/paramedics involved, and of staff who performed the follow-up4 monthsDescription of staff involved
Feasibility of measuring exhaled carbon monoxide3 months after emergency consultationProportion of patients with a carbon monoxide measurement expired
Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal3 months after emergency consultation
proportion of patients who participated in consultations at D7 and M1Day 7 and 1 month after emergency consultationAssessment of the patient circuit
Number of smoked cigarettesDay 7, 1 month and 3 month after emergency consultationNumber of cigarettes smoked daily at 7 days, 1 and 3 months, declarative
Patients' adherence to the intervention3 month after emergency consultation\- 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
Emergency teams' adherence to the intervention3 month after emergency consultationQuestionnaire 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).
Patients ' adherence to the intervention, according to demographic criteria.3 month after emergencyDescription of the population according to age, gender, socio-economic characteristics, grounds for appeal
Effectiveness of the smoking cessation interventionDay 7 and 1 month after emergency consultationProportion of patients weaned at 7 days and at 1 month assessed, declarative, collected by phone

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026