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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT05552534
Collaborator
(none)
152
1
2
16.9
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: STIR PROTOCOL
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Nov 3, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Feasibility and efficacy of a smoking cessation intervention [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 Outcome Measures

  1. proportion of patients who participated in consultations at D7 and M1 [Day 7 and 1 month after emergency consultation]

    Assessment of the patient circuit

  2. description of the procedure (duration of the inclusion) [4 months]

    Description of the research circuit

  3. number of patients who refused to participate [4 months]

    Description of the procedure's barriers

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

    Description of staff involved

  5. Feasibility of measuring exhaled carbon monoxide [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 [3 months after emergency consultation]

  7. Effectiveness of the smoking cessation intervention [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 [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 [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 [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. [3 month after emergency]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emergency department Hospital Pitié-Salpêtrière Paris France 75013

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Anne Laure Philippon, MD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05552534
Other Study ID Numbers:
  • APHP220066
  • ID RCB 2021-A03003-38
First Posted:
Sep 23, 2022
Last Update Posted:
Nov 25, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 25, 2022