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

NCT06789536 | Not Yet Recruiting

• 1 other identifier: APHP241029
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 4

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.

Conditions

Smoking Addiction

Keywords

Smoking; Addictology; Nicotine replacement therapy; Paramedical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 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 achieved smoking cessation at 3 and 6 months after hospital discharge

  3 and 6 months after enrollment

• The patients' quality of life score

  1, 3, and 6 months after enrollment

• The patient's anxiety and depression

  1, 3, and 6 months after enrollment

Study Arms (2)

Trained nurses

EXPERIMENTAL

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

No trained nurses

NO INTERVENTION

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.

Interventions

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 OTHER

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.

Trained nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• French National Cancer Institute (Institut National Du Cancer - France): collaborator
• Institut de Recherche en Santé Publique, France: collaborator

Study Sites (4)

Hôpital européen Georges-Pompidou - Hypertension artérielle et médecine vasculaire

Paris, France

Location

Hôpital européen Georges-Pompidou - Néphrologie

Paris, France

Location

Hôpital européen Georges-Pompidou - Pneumologie

Paris, France

Location

Hôpital européen Georges-Pompidou - USIC

Paris, France

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anne-Isabelle Tropeano

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcef Sekour

CONTACT

+33156095823; youcef.sekour@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 23, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• 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).

Locations

FR (4)