Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 7:43 AM
Study NCT ID:
NCT05552534
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2022-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of an Intervention of Screening, Treatment Initiation and Referral to PROmote Smoking CEssation in Emergency Department Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSCEED
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID RCB 2021-A03003-38 | OTHER | ANSM | View |