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NCT Number: NCT06789536

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

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.

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Key information

Conditions

Smoking Addiction Behavior Smoking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. smoking cessation one month after hospital discharge

    Time frame: 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 outcomes

  1. 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 average number of cigarettes smoked per day at 1, 3, and 6 months after hospital discharge based on self-reported data

  2. 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 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.

  3. 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 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.

  4. The patients' quality of life score

    Time frame: 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)

  5. The patient's anxiety and depression

    Time frame: 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)

  6. The professional satisfaction score of nurses

    Time frame: 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)

  7. Proportion of patients accessing an addiction center

    Time frame: 6 months after enrollment

    The proportion of patients who accessed an addiction center 6 months after hospital discharge.

  8. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Youcef Sekour

CONTACT

[email protected]

+33156095823

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut de Recherche en Santé Publique, France
  • National Cancer Institute, France

Registry information

Acronym: NICOTINURSE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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