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

Primary Purpose

Tobacco Cessation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
STIR PROTOCOL
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tobacco Cessation focused on measuring Emergency medicine, Public Health, Addictionology, Smoking cessation, Tobacco dependence treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency department Hospital Pitié-SalpêtrièreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

proportion of patients who participated in consultations at D7 and M1
Assessment of the patient circuit
description of the procedure (duration of the inclusion)
Description of the research circuit
number of patients who refused to participate
Description of the procedure's barriers
Number of doctors/paramedics involved, and of staff who performed the follow-up
Description of staff involved
Feasibility of measuring exhaled carbon monoxide
Proportion of patients with a carbon monoxide measurement expired
Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal
Effectiveness of the smoking cessation intervention
Proportion of patients weaned at 7 days and at 1 month assessed, declarative, collected by phone
Number of smoked cigarettes
Number of cigarettes smoked daily at 7 days, 1 and 3 months, declarative
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
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).
Patients ' adherence to the intervention, according to demographic criteria.
Description of the population according to age, gender, socio-economic characteristics, grounds for appeal

Full Information

First Posted
April 4, 2022
Last Updated
April 17, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05552534
Brief Title
Impact of an Intervention of Screening, Treatment Initiation and Referral to PROmote Smoking CEssation in Emergency Department Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Cessation
Keywords
Emergency medicine, Public Health, Addictionology, Smoking cessation, Tobacco dependence treatment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
STIR PROTOCOL
Intervention Description
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 Outcome Measure Information:
Title
Feasibility and efficacy of a smoking cessation intervention
Description
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
Time Frame
3 months after emergency consultation
Secondary Outcome Measure Information:
Title
proportion of patients who participated in consultations at D7 and M1
Description
Assessment of the patient circuit
Time Frame
Day 7 and 1 month after emergency consultation
Title
description of the procedure (duration of the inclusion)
Description
Description of the research circuit
Time Frame
4 months
Title
number of patients who refused to participate
Description
Description of the procedure's barriers
Time Frame
4 months
Title
Number of doctors/paramedics involved, and of staff who performed the follow-up
Description
Description of staff involved
Time Frame
4 months
Title
Feasibility of measuring exhaled carbon monoxide
Description
Proportion of patients with a carbon monoxide measurement expired
Time Frame
3 months after emergency consultation
Title
Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal
Time Frame
3 months after emergency consultation
Title
Effectiveness of the smoking cessation intervention
Description
Proportion of patients weaned at 7 days and at 1 month assessed, declarative, collected by phone
Time Frame
Day 7 and 1 month after emergency consultation
Title
Number of smoked cigarettes
Description
Number of cigarettes smoked daily at 7 days, 1 and 3 months, declarative
Time Frame
Day 7, 1 month and 3 month after emergency consultation
Title
Patients' adherence to the intervention
Description
- 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
Time Frame
3 month after emergency consultation
Title
Emergency teams' adherence to the intervention
Description
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).
Time Frame
3 month after emergency consultation
Title
Patients ' adherence to the intervention, according to demographic criteria.
Description
Description of the population according to age, gender, socio-economic characteristics, grounds for appeal
Time Frame
3 month after emergency

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Laure Philippon, MD
Phone
01 84 82 76 51
Email
annelaurephi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Leblanc, Nurse degree, PhD.
Email
judith.leblanc@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Laure Philippon, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency department Hospital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Laure Philippon, MD
Email
annelaurephi@gmail.com
First Name & Middle Initial & Last Name & Degree
Judith LEBLANC
Email
judith.leblanc@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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