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Evaluation of the Effectiveness of Routine Nurse Education in Prescribing Nicotine Replacement Therapy for Hospitalized Smokers in a University Hospital

Evaluation of the Effectiveness of Routine Nurse Education in Prescribing Nicotine Replacement Therapy for Hospitalized Smokers in a University Hospital

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06789536
Acronym
NICOTINURSE
Enrollment
442
Registered
2025-01-23
Start date
2025-03-31
Completion date
2028-08-31
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Addiction

Keywords

Smoking, Addictology, Nicotine replacement therapy, Paramedical

Brief 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 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?

Interventions

OTHERtraining 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

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.

Sponsors

French National Cancer Institute (Institut National Du Cancer - France)
CollaboratorUNKNOWN
Institut de Recherche en Santé Publique, France
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
smoking cessation one month after hospital discharge1 month after enrollmentThe 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.

Secondary

MeasureTime frameDescription
The proportion of patients who reduced their consumption by at least 50% compared to their initial consumption1, 3, and 6 months after enrollmentThe 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.
The proportion of patients who achieved smoking cessation at 3 and 6 months after hospital discharge3 and 6 months after enrollmentThe 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.
The patients' quality of life score1, 3, and 6 months after enrollmentThe 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)
The average number of cigarettes smoked per day at 1, 3, and 6 months after hospital discharge1, 3 and 6 months after enrollmentThe average number of cigarettes smoked per day at 1, 3, and 6 months after hospital discharge based on self-reported data
The professional satisfaction score of nursesBefore the training and through study completion (41 months)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)
Proportion of patients accessing an addiction center6 months after enrollmentThe proportion of patients who accessed an addiction center 6 months after hospital discharge.
The proportion of patients who received a nurse-prescribed nicotine replacement therapy (NRT)During hospitalization (up to 2 months) and at discharge (up to 2 months)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.
The patient's anxiety and depression1, 3, and 6 months after enrollmentThe 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)

Countries

France

Contacts

Primary ContactYoucef Sekour
youcef.sekour@aphp.fr+33156095823

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026