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: 10065030
• 负责人: Sandra Jane Japuntich
• 金额: $ 21.06万
• 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 2022-07-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10065030
• 关键词: Abstinence; Address; American; Attitude; Behavior; Behavior Control; Biological; Cigarette; Clinical; Clinical Trials; Communities; Cost Effectiveness Analysis; Counseling; Data; Databases; Dental; Dental Care; Dental General Practice; Dental Hygienists; Dentists; Disease; Documentation; Education; Effectiveness; Evaluation; Evidence based treatment; Failure; Feedback; Future; Goals; Guidelines; Happiness; Health Professional; Health Services; 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; Process; 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; base; brief advice; brief intervention; cigarette smoking; clinical practice; cost effectiveness; effectiveness implementation trial; effectiveness testing; evidence base; implementation research; improved; innovation; interest; malignant mouth neoplasm; mortality; nicotine patch; nicotine replacement; nicotine use; oral care; pilot trial; post intervention; practice-based research network; prevent; primary outcome; 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.

吸烟对口腔健康有深远的负面影响。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 在没有戒烟药物的帮助下，以复发告终。美国牙科卫生师协会 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，并建议 吸烟者戒烟接受咨询(Ask-Adviser-Refer；AAR)。AAR直接将患者与咨询联系起来，但 而不是药物治疗，它可以在不依赖咨询的情况下将戒断率提高一倍。事实上，很少有牙医开出处方 戒烟药物。未能将吸烟者与药物联系起来是一个严重错失的预防机会 疾病和拯救生命。尼古丁替代疗法抽样(NRTS)指的是为所有吸烟者提供， 不管目前有没有戒烟的兴趣，都可以免费试用非处方药NRT产品和简单使用 指示。NRT已被证明可以增加戒烟尝试和戒烟率。牙科设置 是NRT的理想选择，因为NRT可以很容易地与AAR结合并提供口腔样本 护理产品在牙科护理环境中是常规和普遍的。拟议的UG3/UH3项目将测试 NRT在牙科实践中的有效性。在为期两年的临床试验计划阶段(UG3)，我们将完成 所有必要的里程碑，以确定研究方案的可行性和可接受性，并为3年 临床试验实施阶段(UH3)。UG3活动将包括与利益相关者面谈，以评估最初的 拟议的研究干预措施和程序、试点测试、方案改进的可接受性和可行性； 以及为UH3试验招募从业者。在UH3试验中，我们建议进行一组随机、 混合型1实施-有效性试验比较AAR+NRT(NRT)和增强型普通护理(ET； AAR+电动牙刷；N=50名从业者，每次执业限1名；N=1200名患者) 东北和中西部地区的全国牙科实践研究网络。研究干预措施 将由训练有素的实践工作人员在实践中交付。我们的中心假设是NRT将产生 节欲比率比ET更高。我们的主要结果将是经过生物验证的，7天的流行率 在干预后6个月禁欲。我们还预测，与ET相比，NRT将增加 戒烟，减轻吸烟负担，提高NRT利用率。我们将进行多方利益相关者 对NRTS干预的可行性和可接受性以及成本效益的过程评估 分析，以帮助今后的执行工作。总体而言，我们预计，由于这个项目，我们将 确定NRT在牙科实践中的可行性、可接受性和有效性，并确定NRT 具有很高的转化为临床实践的潜力。