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Completed

NCT Number: NCT05552534

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency department Hospital Pitié-Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STIR PROTOCOL

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.

Primary outcomes

  1. Feasibility and efficacy of a smoking cessation intervention

    Time frame: 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

Secondary outcomes

  1. proportion of patients who participated in consultations at D7 and M1

    Time frame: Day 7 and 1 month after emergency consultation

    Assessment of the patient circuit

  2. description of the procedure (duration of the inclusion)

    Time frame: 4 months

    Description of the research circuit

  3. number of patients who refused to participate

    Time frame: 4 months

    Description of the procedure's barriers

  4. Number of doctors/paramedics involved, and of staff who performed the follow-up

    Time frame: 4 months

    Description of staff involved

  5. Feasibility of measuring exhaled carbon monoxide

    Time frame: 3 months after emergency consultation

    Proportion of patients with a carbon monoxide measurement expired

  6. Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal

    Time frame: 3 months after emergency consultation

  7. Effectiveness of the smoking cessation intervention

    Time frame: Day 7 and 1 month after emergency consultation

    Proportion of patients weaned at 7 days and at 1 month assessed, declarative, collected by phone

  8. Number of smoked cigarettes

    Time frame: Day 7, 1 month and 3 month after emergency consultation

    Number of cigarettes smoked daily at 7 days, 1 and 3 months, declarative

  9. Patients' adherence to the intervention

    Time frame: 3 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
  10. Emergency teams' adherence to the intervention

    Time frame: 3 month after emergency consultation

    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).

  11. Patients ' adherence to the intervention, according to demographic criteria.

    Time frame: 3 month after emergency

    Description of the population according to age, gender, socio-economic characteristics, grounds for appeal

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: PROSCEED

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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