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ClinicalTrials.gov ID

NCT06789536

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

442Estimated

Last Update Posted

Jan 23, 2025Actual

Start Date

Mar 2025Estimated

Primary Completion Date

Mar 2028Estimated

Completion Date

Aug 2028Estimated

Official Title

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

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?

• Smoking Addiction

• 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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

National Cancer Institute, FranceOTHER_GOV

Institut de Recherche en Santé Publique, FranceOTHER

helene.lazareth@aphp.fr+33156093362

jean.pastre@aphp.fr+33156093461

etienne.puymirat@aphp.fr+33156093810