Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices

尼古丁替代疗法采样在牙科实践中的有效性

• 批准号: 10629020
• 负责人: Sandra Jane Japuntich
• 金额: $ 80.7万
• 依托单位: HENNEPIN HEALTHCARE RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10629020
• 关键词: Abstinence; Address; American; Attitude; Behavior; Behavior Control; Cigarette; Clinical; Clinical Trials; Communities; Cost Effectiveness Analysis; Counseling; Data; Databases; Dental; Dental Care; Dental General Practice; Dental Hygienists; Dentists; Disease; Documentation; Drug Prescriptions; Education; Effectiveness; Evidence based treatment; Failure; Feedback; Goals; Guidelines; Happiness; Health Professional; Hour; Hybrids; Hygiene; Incidence; Instruction; Intervention; Intervention Studies; Interview; Knowledge; Manuals; Midwestern United States; Morbidity - disease rate; Motivation; Nicotine; Oral health; Patients; Periodontal Diseases; Pharmaceutical Preparations; Phase; Policies; Postoperative Period; Preparation; Prevalence; Procedures; Promoting Action on Research Implementation in Health Services framework; Protocols documentation; Provider; Randomized; Readiness; Recovery; Relapse; Research; Safety; Sampling; Self Efficacy; Smoke; Smoker; Smoking; Smoking Cessation Intervention; State Interests; Surveys; Testing; Tobacco; Toothbrushing; Training; Translations; Visit; acceptability and feasibility; base; brief advice; brief intervention; cigarette smoking; clinical practice; clinical trial implementation; cost effectiveness; effectiveness implementation trial; effectiveness testing; evidence base; future implementation; implementation efforts; implementation evaluation; improved; innovation; interest; malignant mouth neoplasm; mortality; nicotine patch; nicotine replacement; nicotine use; oral care; pilot test; pilot trial; post intervention; practice-based research network; prevent; primary outcome; process evaluation; quitline; recruit; reduce tobacco use; smoking abstinence; smoking cessation; treatment as usual; trial comparing; wound healing

Cigarette smoking has profound negative effects on oral health. Smoking cessation decreases the incidence and progression of oral health problems. Most smokers attempt to quit, but the majority of quit attempts are unaided by smoking cessation medications and end in relapse. The American Dental Hygienists Association recommends that all oral health professionals Ask patients if they smoke, Advise smokers to quit, and Refer smokers to quitlines for counseling (Ask-Advise-Refer; AAR). AAR connects patients directly to counseling but not to medication, which can double cessation rates independent of counseling. Indeed, few dentists prescribe cessation medications. Failure to connect smokers to medication is a critical missed opportunity to prevent disease and save lives. Nicotine Replacement Therapy Sampling (NRTS) refers to providing all smokers, regardless of current interest in quitting, with free samples of over-the-counter NRT products and brief use instructions. NRTS has been shown to increase quit attempts and smoking abstinence rates. Dental settings are an ideal fit for NRTS because NRTS could easily be combined with AAR and providing samples of oral care products is routine and universal in dental care settings. The proposed UG3/UH3 project will test the effectiveness of NRTS in dental practices. In the 2-year Clinical Trial Planning Phase (UG3), we will complete all required milestones to establish feasibility and acceptability of study protocols and prepare for the 3-year Clinical Trial Implementation Phase (UH3). UG3 activities will include stakeholder interviews to evaluate initial acceptability and feasibility of proposed study interventions and procedures, pilot testing, protocol refinement, and recruitment of practitioners for the UH3 trial. In the UH3 trial, we propose to conduct a cluster randomized, hybrid type 1 implementation-effectiveness trial comparing AAR + NRTS (NRTS) to enhanced usual care (ET; AAR + electric toothbrush; N = 50 practitioners, limited to 1 per practice; N = 1200 patients) recruited from the Northeast and Midwest Regions of the National Dental Practice-Based Research Network. Study interventions will be delivered within the practices by trained practice staff. Our central hypothesis is that NRTS will produce greater abstinence rates than ET. Our primary outcome will be biologically verified, 7-day point prevalence abstinence at 6-months post-intervention. We also predict that compared to ET, NRTS will increase rates of quit attempts, reduce smoking heaviness, and increase NRT utilization. We will conduct a multi-stakeholder process evaluation of the feasibility and acceptability of the NRTS intervention and a cost-effectiveness analysis to aid future implementation efforts. Overall, we expect that, as a result of this project, we will establish the feasibility, acceptability, and effectiveness of NRTS in dental practices and determine that NRTS has high potential for translation to clinical practice.

吸烟对口腔健康有严重的负面影响。戒烟可降低发病率 和口腔健康问题的进展。大多数吸烟者试图戒烟，但大多数戒烟尝试都是 没有戒烟药物的帮助，最终复发。美国牙科医师协会 建议所有口腔健康专业人员询问患者是否吸烟，建议吸烟者戒烟， 戒烟咨询热线（Ask-Advise-Refer; AAR）。AAR将患者直接与咨询联系起来， 而不是药物治疗，药物治疗可以使戒烟率增加一倍，而不需要咨询。事实上，很少有牙医 停止药物。未能将吸烟者与药物联系起来是一个关键的错失机会， 疾病，拯救生命。尼古丁替代疗法采样（NRTS）是指向所有吸烟者提供， 无论目前戒烟的兴趣，与非处方NRT产品的免费样品和简短的使用 指令NRTS已被证明可以增加戒烟尝试和戒烟率。牙科设置 是NRTS的理想选择，因为NRTS可以很容易地与AAR结合， 护理产品在牙齿护理环境中是常规的和普遍的。拟议的UG 3/UH 3项目将测试 NRTS在牙科实践中的有效性。在为期2年的临床试验计划阶段（UG 3），我们将完成 确定研究方案的可行性和可接受性并准备3年 临床试验实施阶段（UH 3）。UG 3活动将包括利益相关者访谈， 拟定研究干预措施和程序的可接受性和可行性，中试测试，方案完善， 并为UH 3试验招募从业人员。在UH 3试验中，我们建议进行随机分组， 比较AAR + NRTS（NRTS）与增强常规护理（ET; AAR +电动牙刷; N = 50名执业医师，每次执业仅限1名; N = 1200名患者）， 东北和中西部地区的国家牙科实践为基础的研究网络。研究干预 将由经过培训的实践工作人员在实践中提供。我们的中心假设是，NRTS将产生 比ET更高的禁欲率。我们的主要结果将是生物学验证，7天点患病率 干预后6个月的禁欲率。我们还预测，与ET相比，NRTS将增加 戒烟尝试，减少吸烟量，增加NRT的使用。我们将进行一次多方利益相关者 对NRTS干预的可行性和可接受性以及成本效益进行过程评估 分析，以帮助未来的实施工作。总的来说，我们希望，由于这个项目，我们将 确定NRTS在牙科实践中的可行性、可接受性和有效性，并确定NRTS 具有很高的转化为临床实践的潜力。