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Not yet recruiting NCT06789536

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

No phase Interventional Smoking Addiction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Smoking Addiction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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
    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.

Primary outcome measures

  • smoking cessation one month after hospital discharge [Time frame: 1 month after enrollment]
Secondary outcome measures (8)
  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 4 centers
  • Hôpital européen Georges-Pompidou - Hypertension artérielle et médecine vasculaire — Paris
  • Hôpital européen Georges-Pompidou - Néphrologie — Paris
  • Hôpital européen Georges-Pompidou - Pneumologie — Paris
  • Hôpital européen Georges-Pompidou - USIC — Paris

Identifiers

NCT: NCT06789536 · APHP241029

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗