Clinical trial NCT06789536: Evaluation of the Effectiveness of Routine Nurse Education in Prescribing Nicotine Replacement Therapy for Hospitalized Smokers in a University Hospital
Official title: Evaluation of the Effectiveness of Routine Nurse Education in Prescribing Nicotine Replacement Therapy for Hospitalized Smokers in a University Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Addiction
Keywords: Smoking
Addictology
Nicotine replacement therapy
Paramedical
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: French National Cancer Institute (Institut National Du Cancer - France)
name: Institut de Recherche en Santé Publique, France
First posted: 2025-01-23
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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?

Eligibility criteria: 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.

Primary outcomes:
measure: smoking cessation one month after hospital discharge
timeFrame: 1 month after enrollment
Secondary outcomes:
measure: The average number of cigarettes smoked per day at 1, 3, and 6 months after hospital discharge
timeFrame: 1, 3 and 6 months after enrollment
measure: The proportion of patients who reduced their consumption by at least 50% compared to their initial consumption
timeFrame: 1, 3, and 6 months after enrollment
measure: The proportion of patients who achieved smoking cessation at 3 and 6 months after hospital discharge
timeFrame: 3 and 6 months after enrollment
measure: The patients' quality of life score
timeFrame: 1, 3, and 6 months after enrollment
measure: The patient's anxiety and depression
timeFrame: 1, 3, and 6 months after enrollment
measure: The professional satisfaction score of nurses
timeFrame: Before the training and through study completion (41 months)
measure: Proportion of patients accessing an addiction center
timeFrame: 6 months after enrollment
measure: The proportion of patients who received a nurse-prescribed nicotine replacement therapy (NRT)
timeFrame: During hospitalization (up to 2 months) and at discharge (up to 2 months)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou - Hypertension artérielle et médecine vasculaire
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou - Néphrologie
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou - Pneumologie
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou - USIC
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne-Isabelle Tropeano
role: PRINCIPAL_INVESTIGATOR
References: