Tobacco CessationPROSCEEDNCT05552534
Impact of an Intervention of Screening, Treatment Initiation and Referral to PROmote Smoking CEssation in Emergency Department Patients
A study testing STIR PROTOCOL in people with Tobacco Cessation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Cessation
- What is being tested?
- STIR PROTOCOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2022to 3 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Age ≥ 18 years
- Caregiver working in one of the 3 departments participating in the study
- Signature of free and informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Tobacco Cessation
- Being tested
- STIR PROTOCOL
- Keywords
- Emergency medicine, Public Health, Addictionology, Smoking cessation, Tobacco dependence treatment
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STIR PROTOCOLOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: STIR PROTOCOL |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after emergency consultation
Secondary outcomes (11)
proportion of patients who participated in consultations at D7 and M1
Assessment of the patient circuit
Measured: Day 7 and 1 month after emergency consultation
description of the procedure (duration of the inclusion)
Description of the research circuit
Measured: 4 months
number of patients who refused to participate
Description of the procedure's barriers
Measured: 4 months
Number of doctors/paramedics involved, and of staff who performed the follow-up
Description of staff involved
Measured: 4 months
Feasibility of measuring exhaled carbon monoxide
Proportion of patients with a carbon monoxide measurement expired
Measured: 3 months after emergency consultation
Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal
Measured: 3 months after emergency consultation
Effectiveness of the smoking cessation intervention
Proportion of patients weaned at 7 days and at 1 month assessed, declarative, collected by phone
Measured: Day 7 and 1 month after emergency consultation
Number of smoked cigarettes
Number of cigarettes smoked daily at 7 days, 1 and 3 months, declarative
Measured: Day 7, 1 month and 3 month after emergency consultation
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
Measured: 3 month after emergency consultation
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).
Measured: 3 month after emergency consultation
Patients ' adherence to the intervention, according to demographic criteria.
Description of the population according to age, gender, socio-economic characteristics, grounds for appeal
Measured: 3 month after emergency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start3 Nov 2022
- Primary completion3 May 2024
- Study completion3 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Laure Philippon, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552534
- Sponsor's protocol ID
- APHP220066
- Other IDs
- ID RCB 2021-A03003-38
- Acronym
- PROSCEED
- Status last verified
- Mar 2025
- First submitted
- 4 Apr 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05552534
- Acronym / sponsor ID
- PROSCEED / APHP220066
- Conditions
- Tobacco Cessation
- Keywords
- Emergency medicine, Public Health, Addictionology, Smoking cessation, Tobacco dependence treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 Aug 2024 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: STIR PROTOCOL |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STIR PROTOCOLScreening, 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. | Other | Intervention group |
Primary outcome
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
11 secondary outcomes
proportion of patients who participated in consultations at D7 and M1
Time frame: Day 7 and 1 month after emergency consultation
description of the procedure (duration of the inclusion)
Time frame: 4 months
number of patients who refused to participate
Time frame: 4 months
Number of doctors/paramedics involved, and of staff who performed the follow-up
Time frame: 4 months
Feasibility of measuring exhaled carbon monoxide
Time frame: 3 months after emergency consultation
Correlation of the measurement of exhaled carbon monoxide and declaration of withdrawal
Time frame: 3 months after emergency consultation
Effectiveness of the smoking cessation intervention
Time frame: Day 7 and 1 month after emergency consultation
Number of smoked cigarettes
Time frame: Day 7, 1 month and 3 month after emergency consultation
Patients' adherence to the intervention
Time frame: 3 month after emergency consultation
Emergency teams' adherence to the intervention
Time frame: 3 month after emergency consultation
Patients ' adherence to the intervention, according to demographic criteria.
Time frame: 3 month after emergency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Tobacco Cessation
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Laure Philippon, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STIR PROTOCOL in people with Tobacco Cessation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and efficacy of a smoking cessation intervention (time frame: 3 months after emergency consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.