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The NICOTINURSE Trial: Protocol for a stepped-wedge trial to implement nurse-led smoking cessation support in a tertiary care hospital

Year: 2026

Type: article

Abstract: Smoking cessation support is still lacking during hospital stay, leading smokers to suffer from withdrawal symptoms and missing opportunities to help them quit. In this context, NICOTINURSE is a stepped-wedge cluster randomized trial aimed to evaluate the effectiveness of a nurse-led support and nicotine replacement therapy (NRT) prescription during smokers' hospital stay in four departments of a university hospital on one-month abstinence after discharge with a follow-up of quit attempts at 3 and 6 months. This is a stepped-wedge cluster trial, including four hospital departments. Inpatients who smoke in the experimental group will receive structured counseling and NRT prescribed by trained nurses in smoking cessation before discharge, while smokers in the control group receive standard care. The primary outcome is one-month abstinence post-discharge confirmed biochemically. Secondary outcomes, assessed at 1, 3, and 6 months post-discharge, include: abstinence, mean number of cigarettes smoked daily, quality of life scale, anxiety and depression symptoms score, addiction center use, and prescribed NRT during hospitalization and at discharge. Nurse job satisfaction will be measured at the beginning and at the end of the study. Statistical analyses will compare intervention and control groups using models appropriate for the stepped-wedge cluster randomized design (two-sided α = 0.05). Based on an expected 1-month abstinence rate of 15% in the control group and 30% in the intervention group, with 80% power, an intraclass correlation coefficient of 0.30, and 5% loss to follow-up, a total sample size of 442 participants is required. All data collected about the study participants will be anonymized. Results will be communicated to participants, hospital departments' staff and other relevant groups without any restrictions. CLINICAL TRIAL REGISTRATION: The study is registered on the official website of ClinicalTrials.gov. IDENTIFIER: NCT06789536.

Source: Tobacco Induced Diseases

DOI: 10.18332/tid/231136

Authors: Anusha Savundrarajan, Anne-Isabelle Tropeano, Aurelie Vilfaillot, Marie-Laure Delaporte, Anne-Laurence Le Faou

Institutions: Hôpital Européen Georges-Pompidou, Université Paris Cité, Assistance Publique – Hôpitaux de Paris

Language: English

Topic: Smoking Behavior and Cessation

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,372