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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking Addiction
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 442
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youcef SEKOUR; Phone Number: +33156095823; Email: youcef.sekour@aphp.fr

Study Locations

• France
  • Paris, France
    • Hôpital européen Georges-Pompidou - Hypertension artérielle et médecine vasculaire
    • Contact: Marie-Laure DELAPORTE; Phone Number: +33156093058; Email: marie-laure.delaporte@aphp.fr
  • Paris, France
    • Hôpital européen Georges-Pompidou - Néphrologie
    • Contact: Hélène LAZARETH; Phone Number: +33156093362; Email: helene.lazareth@aphp.fr
  • Paris, France
    • Hôpital européen Georges-Pompidou - Pneumologie
    • Contact: Jean PASTRE; Phone Number: +33156093461; Email: jean.pastre@aphp.fr
  • Paris, France
    • Hôpital européen Georges-Pompidou - USIC
    • Contact: Etienne PUYMIRAT; Phone Number: +33156093810; Email: etienne.puymirat@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trained nurses; 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.	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.
No Intervention: No trained nurses; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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)	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)	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)	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.	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.	During hospitalization (up to 2 months) and at discharge (up to 2 months)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut de Recherche en Santé Publique, France; French National Cancer Institute (Institut National Du Cancer - France)
• Investigators: Principal Investigator: Anne-Isabelle Tropeano, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Smoking; Nicotine replacement therapy; Addictology; Paramedical
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: APHP241029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication
• IPD Sharing Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No