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

Tobacco Cessation Clinical Trial

— PROSCEED  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552534
• Other study ID #: APHP220066
• Secondary ID: ID RCB 2021-A030
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Anne Laure Philippon, MD
• Phone: 01 84 82 76 51
• Email: annelaurephi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: June 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Tobacco Cessation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Emergency department Hospital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	proportion of patients who participated in consultations at D7 and M1	Assessment of the patient circuit	Day 7 and 1 month after emergency consultation
Secondary	description of the procedure (duration of the inclusion)	Description of the research circuit	4 months
Secondary	number of patients who refused to participate	Description of the procedure's barriers	4 months
Secondary	Number of doctors/paramedics involved, and of staff who performed the follow-up	Description of staff involved	4 months
Secondary	Feasibility of measuring exhaled carbon monoxide	Proportion of patients with a carbon monoxide measurement expired	3 months after emergency consultation
Secondary	Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal		3 months after emergency consultation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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