Evaluation of the Effectiveness of Routine Nurse Education in Prescribing Nicotine Replacement Therapy for Hospitalized Smokers in a University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 442
- 试验地点
- 4
- 主要终点
- smoking cessation one month after hospital discharge
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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)
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.
结局指标
主要结局
smoking cessation one month after hospital discharge
时间窗: 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.
次要结局
- The proportion of patients who achieved smoking cessation at 3 and 6 months after hospital discharge(3 and 6 months after enrollment)
- 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 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)
- The professional satisfaction score of nurses(Before the training and through study completion (41 months))
- Proportion of patients accessing an addiction center(6 months after enrollment)
- The proportion of patients who received a nurse-prescribed nicotine replacement therapy (NRT)(During hospitalization (up to 2 months) and at discharge (up to 2 months))