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

Not Applicable

Not yet recruiting

• Conditions: Smoking Addiction

• Registration Number: NCT06789536
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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?

Study Timeline

• Study First Submitted: 2024-12-12
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Study Start: 2025-03
• Primary Completion: 2028-03
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 442

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
smoking cessation one month after hospital discharge	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.

Secondary Outcome Measures

Name	Time	Method
The average number of cigarettes smoked per day at 1, 3, and 6 months after hospital discharge	1, 3 and 6 months after enrollment	The average number of cigarettes smoked per day at 1, 3, and 6 months after hospital discharge based on self-reported data
The proportion of patients who reduced their consumption by at least 50% compared to their initial consumption	1, 3, and 6 months after enrollment	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.
The proportion of patients who achieved smoking cessation at 3 and 6 months after hospital discharge	3 and 6 months after enrollment	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.
The patients' quality of life score	1, 3, and 6 months after enrollment	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)
The patient's anxiety and depression	1, 3, and 6 months after enrollment	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)
The professional satisfaction score of nurses	Before 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 center	6 months after enrollment	The 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.

Trial Locations

Locations (4)

Hôpital européen Georges-Pompidou - Hypertension artérielle et médecine vasculaire; 🇫🇷 Paris, France

Hôpital européen Georges-Pompidou - Néphrologie; 🇫🇷 Paris, France

Hôpital européen Georges-Pompidou - Pneumologie; 🇫🇷 Paris, France

Hôpital européen Georges-Pompidou - USIC; 🇫🇷 Paris, France