Smoking AddictionNICOTINURSENCT06789536
Evaluation of the Effectiveness of Routine Nurse Education in Prescribing Nicotine Replacement Therapy for Hospitalized Smokers in a University Hospital
A study testing training nurses to prescribe nicotine substitutes, to adapt doses and to transmit to the outpatient physician and/or nurse nurse to facilitate the continuation of treatment in people with Smoking Addiction, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
The goal of this study is to determine whether training nurses to prescribe nicotine replacement therapy (NRT) can increase the proportion of smoking cessation at one month after hospital discharge among active smokers (daily or occasional tobacco use) hospitalized at the European Hospital Georges Pompidou in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Addiction
- What is being tested?
- training nurses to prescribe nicotine substitutes, to adapt doses and to transmit to the outpatient physician and/or nurse nurse to facilitate the continuation of treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 4 sitesFrance
- Study dates
- Mar 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- An active smoking patient (daily or occasional tobacco use) hospitalized in the following departments: hypertension/vascular medicine, nephrology, pulmonology, or the coronary care unit (CCU).
- Patient residing in the Île-de-France region.
- Proficient in the French language.
- Has signed informed consent.
Who cannot join
- Patient not affiliated with social security;
- Patient under State Medical Aid (AME);
- Patient under legal protection measures;
- Pregnant or breastfeeding patient;
- Patient refusing to participate in the study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Hôpital européen Georges-Pompidou - Hypertension artérielle et médecine vasculaire
Paris
Marie-Laure DELAPORTE, +33156093058, marie-laure.delaporte@aphp.fr
Hôpital européen Georges-Pompidou - Néphrologie
Paris
Hélène LAZARETH, +33156093362, helene.lazareth@aphp.fr
Hôpital européen Georges-Pompidou - Pneumologie
Paris
Jean PASTRE, +33156093461, jean.pastre@aphp.fr
Hôpital européen Georges-Pompidou - USIC
Paris
Etienne PUYMIRAT, +33156093810, etienne.puymirat@aphp.fr
About this study
The goal of this study is to determine whether training nurses to prescribe nicotine replacement therapy (NRT) can increase the proportion of smoking cessation at one month after hospital discharge among active smokers (daily or occasional tobacco use) hospitalized at the European Hospital Georges Pompidou in the following departments: Hypertension/Vascular Medicine, Nephrology, Pulmonology, and the Cardiac Intensive Care Unit.
The main questions it aims to answer are :
Read more
Does training nursing teams in the prescription and adjustment of nicotine replacement therapy increase the proportion of smoking cessation at one month after hospital discharge, defined as a total absence of tobacco consumption for at least seven days prior to the consultation, based on self-report and confirmed by an exhaled carbon monoxide (CO) level of ≤10 ppm? We will compare the usual care provided in the targeted departments with the care provided after all nurses in these departments receive training. The training will involve teaching the prescription of nicotine replacement therapy, dose adjustment, and communication with general practitioners and/or community nurses through a referral letter to facilitate continued care. Nurses will also have access to a dose adjustment document to provide to patients.
Participants will be followed up at discharge and at 1, 3, and 6 months post-discharge. At each visit, they will complete questionnaires on smoking behavior, quality of life, anxiety, and depression symptoms, and an exhaled CO measurement will be performed.
Read the detailed description
Secondary questions it aims to answer are :
Does training nursing teams in the prescription and adjustment of nicotine replacement therapy :
- Reduce the average number of cigarettes smoked per day at 1, 3, and 6 months post-discharge?
- Decrease tobacco consumption by at least 50% at 1, 3, and 6 months post-discharge based on self-reported consumption?
- Increase the proportion of smoking cessation at 3 and 6 months post-discharge, defined as a total absence of tobacco consumption for at least seven days prior to the consultation, based on self-report and confirmed by an exhaled carbon monoxide level of ≤10 ppm?
- Improve patients' quality of life as measured by the SF-12 quality of life scale and symptoms of anxiety and depression assessed by the HAD scale at 1, 3, and 6 months post-discharge?
- Change the proportion of patients who access an addiction treatment center within six months post-discharge?
- Increase the use of nurse-prescribed nicotine replacement therapy during hospitalization and at discharge?
- Enhance nurse satisfaction with their practice?
- Conditions
- Smoking Addiction
- Being tested
- training nurses to prescribe nicotine substitutes, to adapt doses and to transmit to the outpatient physician and/or nurse nurse to facilitate the continuation of treatment
- Keywords
- Smoking, Addictology, Nicotine replacement therapy, Paramedical
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training nurses to prescribe nicotine substitutes, to adapt doses and to transmit to the outpatient physician and/or nurse nurse to facilitate the continuation of treatmentOther
Nurses will undergo training sessions provided by the smoking cessation team to learn how to prescribe nicotine replacement therapy, adjust dosages, and forward a referral letter to the patient's primary care physician and/or community nurse for continuity of care. They will receive a dosage adjustment guide to share with patients. Upon completing the training, nurses will be authorized to prescribe nicotine replacement therapy using the hospital's prescription software.
| Study group | Role | What they receive |
|---|---|---|
| Trained nurses | Experimental | Nurses will participate in two one-hour training sessions, conducted in groups of three. This training will be provided by the smoking cessation team to learn how to prescribe nicotine replacement therapy, adjust dosages, and forward a referral letter to the patient's primary care physician and/or community nurse for continuity of care. They will receive a dosage adjustment guide to share with patients, along with the direct contact number for the smoking cessation team. Upon completing the training, nurses will be authorized to prescribe nicotine replacement therapy using the hospital's prescription software. Training will be spread over 15 days per department to avoid all nurses in the same unit being trained on the same day. Patients will receive information about nicotine replacement therapies and can try different formulations during hospitalization to optimize their choice. The outpatient addiction center team will be available to assist with any prescription-related questions. Receives: Other: training nurses to prescribe nicotine substitutes, to adapt doses and to transmit to the outpatient physician and/or nurse nurse to facilitate the continuation of treatment |
| No trained nurses | No intervention | Physicians are informed about the intervention procedures of the Addiction Liaison Team (ELSA), accessible through a single central call number. Upon request, an ELSA team member visits the bedside of identified smoking patients, provides care recommendations to the attending physician, particularly regarding nicotine replacement therapy, and prescriptions are written by the patient's care team based on ELSA's guidance. ELSA maintains a standardized addiction care record to document recommendations, accessible to the healthcare team. During hospitalization, the team adjusts dosages, refers patients to addiction services or the Tobacco Info Service hotline upon discharge, and provides a nicotine replacement prescription with contact details for the patient's primary care providers. Discharge summaries written by patient's care team often include ELSA's recommendations to inform primary care physicians. Patients requesting continued care at HEGP are scheduled for follow-up appointment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking cessation one month after hospital discharge
The primary outcome is smoking cessation one month after hospital discharge, defined as a total absence of tobacco use for at least 7 days prior to the consultation day, based on self-reported data and confirmed by an exhaled carbon monoxide measurement of 10 ppm or less.
Measured: 1 month after enrollment
Secondary outcomes (8)
The average number of cigarettes smoked per day at 1, 3, and 6 months after hospital discharge
The average number of cigarettes smoked per day at 1, 3, and 6 months after hospital discharge based on self-reported data
Measured: 1, 3 and 6 months after enrollment
The proportion of patients who reduced their consumption by at least 50% compared to their initial consumption
The proportion of patients who reduced their consumption by at least 50% compared to their initial consumption at 1, 3, and 6 months after hospital discharge, based on self-reported consumption.
Measured: 1, 3, and 6 months after enrollment
The proportion of patients who achieved smoking cessation at 3 and 6 months after hospital discharge
The proportion of patients who achieved smoking cessation at 3 and 6 months after hospital discharge, defined as a total absence of tobacco consumption for at least 7 days prior to the consultation day, based on self-reported data and confirmed by an exhaled carbon monoxide measurement of 10 ppm or less.
Measured: 3 and 6 months after enrollment
The patients' quality of life score
The patients' quality of life score measured using the 12-Item Short Form Survey (SF-12) quality of life scale available in the national smoking cessation consultation file published by Santé publique France, at 1, 3, and 6 months after hospital discharge. Minimum value of SF-12 is: 0, Maximum value is: 100 (representing the best possible health)
Measured: 1, 3, and 6 months after enrollment
The patient's anxiety and depression
The patient's anxiety and depression measured using the Hospital Anxiety and Depression Scale (HAD) at 1, 3, and 6 months after hospital discharge. Minimum value is : 0, Maximum value: 42 (representing the worse possible)
Measured: 1, 3, and 6 months after enrollment
The professional satisfaction score of nurses
The professional satisfaction score of nurses with a job satisfaction questionnaires that all nurses participating in the study will complete before the training and after the inclusion of the last patient. The minimum value is : 0 , maximal value : 40 (the best value)
Measured: Before the training and through study completion (41 months)
Proportion of patients accessing an addiction center
The proportion of patients who accessed an addiction center 6 months after hospital discharge.
Measured: 6 months after enrollment
The proportion of patients who received a nurse-prescribed nicotine replacement therapy (NRT)
The proportion of patients who received a nurse-prescribed nicotine replacement therapy (NRT) during hospitalization and at discharge, measured through a data extraction from the prescription software, with the prescription being patient-specific and the nurse's authorization to prescribe recorded by the IT department.
Measured: During hospitalization (up to 2 months) and at discharge (up to 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking AddictionStudies 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
- Sequential
- Model description
- Experimental Design: This is an open, cluster-randomized, stepped-wedge trial comparing smoking cessation rates at 1 month after hospital discharge between patients cared for by nurses trained in prescribing nicotine replacement therapies (NRTs) and those receiving standard care. In this design, departments are divided into 4 clusters, corresponding to nurse teams. At the start of the study, no team will have undergone training. Every 7 months, one team will be trained, with the training taking place over a 2-week period. Once a team is trained, the department will remain in the experimental group until the end of the study. No patients will be included in a department during its 2-week training period. The order in which departments undergo training will be randomized.
- Masking
- None (open label)
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Institut de Recherche en Santé Publique, France
- Responsible party
- Sponsor
- Investigators
- Anne-Isabelle Tropeano, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789536
- Sponsor's protocol ID
- APHP241029
- Acronym
- NICOTINURSE
- Status last verified
- Jan 2025
- First submitted
- 12 Dec 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Routine Nurse Education in Prescribing Nicotine Replacement Therapy for Hospitalized Smokers in a University Hospital
- ClinicalTrials.gov ID
- NCT06789536
- Acronym / sponsor ID
- NICOTINURSE / APHP241029
- Conditions
- Smoking Addiction
- Keywords
- Smoking, Addictology, Nicotine replacement therapy, Paramedical
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Institut de Recherche en Santé Publique, France
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 23 Jan 2025 (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.
The goal of this study is to determine whether training nurses to prescribe nicotine replacement therapy (NRT) can increase the proportion of smoking cessation at one month after hospital discharge among active smokers (daily or occasional tobacco use) hospitalized at the European Hospital Georges Pompidou in the following departments: Hypertension/Vascular Medicine, Nephrology, Pulmonology, and the Cardiac Intensive Care Unit.
The main questions it aims to answer are :
Does training nursing teams in the prescription and adjustment of nicotine replacement therapy increase the proportion of smoking cessation at one month after hospital discharge, defined as a total absence of tobacco consumption for at least seven days prior to the consultation, based on self-report and confirmed by an exhaled carbon monoxide (CO) level of ≤10 ppm? We will compare the usual care provided in the targeted departments with the care provided after all nurses in these departments receive training. The training will involve teaching the prescription of nicotine replacement therapy, dose adjustment, and communication with general practitioners and/or community nurses through a referral letter to facilitate continued care. Nurses will also have access to a dose adjustment document to provide to patients.
Participants will be followed up at discharge and at 1, 3, and 6 months post-discharge. At each visit, they will complete questionnaires on smoking behavior, quality of life, anxiety, and depression symptoms, and an exhaled CO measurement will be performed.
Detailed description
Secondary questions it aims to answer are :
Does training nursing teams in the prescription and adjustment of nicotine replacement therapy :
- Reduce the average number of cigarettes smoked per day at 1, 3, and 6 months post-discharge?
- Decrease tobacco consumption by at least 50% at 1, 3, and 6 months post-discharge based on self-reported consumption?
- Increase the proportion of smoking cessation at 3 and 6 months post-discharge, defined as a total absence of tobacco consumption for at least seven days prior to the consultation, based on self-report and confirmed by an exhaled carbon monoxide level of ≤10 ppm?
- Improve patients' quality of life as measured by the SF-12 quality of life scale and symptoms of anxiety and depression assessed by the HAD scale at 1, 3, and 6 months post-discharge?
- Change the proportion of patients who access an addiction treatment center within six months post-discharge?
- Increase the use of nurse-prescribed nicotine replacement therapy during hospitalization and at discharge?
- Enhance nurse satisfaction with their practice?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental Design: This is an open, cluster-randomized, stepped-wedge trial comparing smoking cessation rates at 1 month after hospital discharge between patients cared for by nurses trained in prescribing nicotine replacement therapies (NRTs) and those receiving standard care. In this design, departments are divided into 4 clusters, corresponding to nurse teams. At the start of the study, no team will have undergone training. Every 7 months, one team will be trained, with the training taking place over a 2-week period. Once a team is trained, the department will remain in the experimental group until the end of the study. No patients will be included in a department during its 2-week training period. The order in which departments undergo training will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Trained nurses | Experimental | Other: training nurses to prescribe nicotine substitutes, to adapt doses and to transmit to the outpatient physician and/or nurse nurse to facilitate the continuation of treatmentNurses will participate in two one-hour training sessions, conducted in groups of three. This training will be provided by the smoking cessation team to learn how to prescribe nicotine replacement therapy, adjust dosages, and forward a referral letter to the patient's primary care physician and/or community nurse for continuity of care. They will receive a dosage adjustment guide to share with patients, along with the direct contact number for the smoking cessation team. Upon completing the training, nurses will be authorized to prescribe nicotine replacement therapy using the hospital's prescription software. Training will be spread over 15 days per department to avoid all nurses in the same unit being trained on the same day. Patients will receive information about nicotine replacement therapies and can try different formulations during hospitalization to optimize their choice. The outpatient addiction center team will be available to assist with any prescription-related questions. |
| No trained nurses | No intervention | –Physicians are informed about the intervention procedures of the Addiction Liaison Team (ELSA), accessible through a single central call number. Upon request, an ELSA team member visits the bedside of identified smoking patients, provides care recommendations to the attending physician, particularly regarding nicotine replacement therapy, and prescriptions are written by the patient's care team based on ELSA's guidance. ELSA maintains a standardized addiction care record to document recommendations, accessible to the healthcare team. During hospitalization, the team adjusts dosages, refers patients to addiction services or the Tobacco Info Service hotline upon discharge, and provides a nicotine replacement prescription with contact details for the patient's primary care providers. Discharge summaries written by patient's care team often include ELSA's recommendations to inform primary care physicians. Patients requesting continued care at HEGP are scheduled for follow-up appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An active smoking patient (daily or occasional tobacco use) hospitalized in the following departments: hypertension/vascular medicine, nephrology, pulmonology, or the coronary care unit (CCU).
- Patient residing in the Île-de-France region.
- Proficient in the French language.
- Has signed informed consent.
Key exclusion criteria (5 listed)
- Patient not affiliated with social security;
- Patient under State Medical Aid (AME);
- Patient under legal protection measures;
- Pregnant or breastfeeding patient;
- Patient refusing to participate in the study.
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 |
|---|---|---|
| training nurses to prescribe nicotine substitutes, to adapt doses and to transmit to the outpatient physician and/or nurse nurse to facilitate the continuation of treatmentNurses will undergo training sessions provided by the smoking cessation team to learn how to prescribe nicotine replacement therapy, adjust dosages, and forward a referral letter to the patient's primary care physician and/or community nurse for continuity of care. They will receive a dosage adjustment guide to share with patients. Upon completing the training, nurses will be authorized to prescribe nicotine replacement therapy using the hospital's prescription software. | Other | Trained nurses |
Primary outcome
smoking cessation one month after hospital discharge
Time frame: 1 month after enrollment
The primary outcome is smoking cessation one month after hospital discharge, defined as a total absence of tobacco use for at least 7 days prior to the consultation day, based on self-reported data and confirmed by an exhaled carbon monoxide measurement of 10 ppm or less.
8 secondary outcomes
The average number of cigarettes smoked per day at 1, 3, and 6 months after hospital discharge
Time frame: 1, 3 and 6 months after enrollment
The proportion of patients who reduced their consumption by at least 50% compared to their initial consumption
Time frame: 1, 3, and 6 months after enrollment
The proportion of patients who achieved smoking cessation at 3 and 6 months after hospital discharge
Time frame: 3 and 6 months after enrollment
The patients' quality of life score
Time frame: 1, 3, and 6 months after enrollment
The patient's anxiety and depression
Time frame: 1, 3, and 6 months after enrollment
The professional satisfaction score of nurses
Time frame: Before the training and through study completion (41 months)
Proportion of patients accessing an addiction center
Time frame: 6 months after enrollment
The proportion of patients who received a nurse-prescribed nicotine replacement therapy (NRT)
Time frame: During hospitalization (up to 2 months) and at discharge (up to 2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Anne-Isabelle Tropeano principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training nurses to prescribe nicotine substitutes, to adapt doses and to transmit to the outpatient physician and/or nurse nurse to facilitate the continuation of treatment in people with Smoking Addiction, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youcef Sekour (+33156095823, youcef.sekour@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoking cessation one month after hospital discharge (time frame: 1 month after enrollment). 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 23 Jan 2025.