Kshtriya Pranav, Goel Sonu, Ghosh Abhishek
Department of Community Medicine & School of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.
Department of Psychiatry, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012, India.
Public Health Pract (Oxf). 2024 Dec 22;9:100581. doi: 10.1016/j.puhip.2024.100581. eCollection 2025 Jun.
Shared decision-making (SDM) incorporates evidence, patient values, and preferences into medical decision-making. SDM and decision aids might promote health professional engagement and patient knowledge of tobacco cessation therapy, improving usage and results. The SDM facilitates talks that lead to better-informed judgements that align with patients' priorities, unlike individual decision-making. Thus, the study will attempt to identify the efficacy of shared decision making in tobacco dependence treatment.
SDM in tobacco cessation therapies in healthcare settings is understudied, thereby this study looks at comparable interventions in different settings to add to the evidence. This suggests that this study on SDM in tobacco cessation therapy, which includes healthcare professionals, aims to assist patients in making evidence- and value-based medical decisions.
This protocol has been registered under the registration number CTRI/2022/10/046793 with the Clinical Trials Registry in India.
共同决策（SDM）将证据、患者价值观和偏好纳入医疗决策。SDM和决策辅助工具可能会促进医疗专业人员参与以及患者对戒烟治疗的了解，从而提高治疗的使用率和效果。与个体决策不同，SDM有助于开展对话，从而做出更明智的判断，使其与患者的优先事项相一致。因此，本研究将试图确定共同决策在烟草依赖治疗中的疗效。
1）双臂平行组随机对照试验（RCT）；2）印度哈里亚纳邦选定的三个政府卫生中心；3）596名年龄≥18岁、前往选定卫生中心门诊部/戒烟中心（TCC）的烟草使用者；4）干预组将使用基于戒烟三谈模型专门设计的决策辅助工具，接受关于开具药物治疗（尼古丁替代疗法、安非他酮）的共同决策过程，而对照组将接受标准护理；5）主要结局包括用于评估7天点患病率戒断情况的尿可替宁分析。次要结局包括患者满意度问卷PSQ-18评分、累计戒烟天数、自我报告的戒烟尝试次数以及戒断率。将对干预组和对照组之间诸如行为状态变化即戒烟情况等结局进行比较。在比较两组时，比例差异将通过卡方检验进行评估，均值差异将通过t检验进行评估。在比较两组结局时将进行意向性分析。
医疗环境中戒烟治疗的共同决策研究较少，因此本研究着眼于不同环境中的类似干预措施以补充证据。这表明这项针对包括医疗专业人员在内的戒烟治疗共同决策的研究旨在帮助患者做出基于证据和价值观的医疗决策。
本方案已在印度临床试验注册中心以注册号CTRI/2022/10/046793注册。
