Internet-based Medication Adherence Program for Nicotine Dependence Treatment

基于互联网的尼古丁依赖治疗药物依从计划

• 批准号: 8580841
• 负责人: JENNIFER B MCCLURE
• 金额: $ 29.17万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-15 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8580841
• 关键词: Abstinence; Address; Adherence; Adverse effects; Adverse event; Aftercare; Algorithms; Behavior; Behavior Therapy; Behavioral; Bupropion; Cause of Death; Clinical; Clinical Psychology; Cognitive; Communication; Computers; Consult; Data; Development; Dose; Early treatment; Effectiveness; Evaluation; FDA approved; Feedback; Foundations; Frequencies; Funding; Future; Goals; Institutes; Internet; Intervention; Interview; Lead; Medical; Medicine; Modeling; Monitor; Motivation; Nicotine Dependence; Nicotine Withdrawal; Nurses; Online Systems; Outcome; Participant; Patient Self-Report; Patients; Personal Computers; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Pharmacy facility; Phase; Physicians; Pilot Projects; Printing; Process; Professional counselor; Program Effectiveness; Provider; Psychiatry; Public Health; Randomized; Reaction; Records; Relapse; Research; Sample Size; Serious Adverse Event; Smoker; Smoking; Societies; Symptoms; System; Telephone; Testing; Time; Treatment Cost; Treatment Effectiveness; Treatment Protocols; United States National Institutes of Health; Withdrawal Symptom; Work; base; clinical care; cost effectiveness; design; effective therapy; effectiveness trial; improved; killings; medically necessary care; medication compliance; nicotine replacement; patient safety; pilot trial; programs; prototype; public health relevance; quitline; randomized trial; self help; skills; skills training; smoking cessation; smoking prevalence; tool; treatment adherence; varenicline; willingness

DESCRIPTION (provided by applicant): One third of all smokers who make an annual quit attempt use one of the three FDA-approved pharmacotherapies (in contrast, <9% use behavioral intervention), but poor adherence is a well-documented problem for each of these medications. For example, we recently found that 50% of smokers taking varenicline had sub-optimal adherence. Non-adherence behavior such as inconsistent medication use, under-dosing, and early treatment discontinuation significantly undermines treatment effectiveness, which may in part explain why the great majority of treated smokers relapse. One way to improve the effectiveness of existing pharmacotherapy and to help more people stop smoking is to enhance treatment adherence. The current pilot study will evaluate the feasibility and acceptability of a prototype Internet-based medication adherence program (iMAP) from the perspective of smokers and clinicians (i.e., system users). iMAP is designed to facilitate ongoing communication between patients and clinicians; enhance adverse event monitoring; and provide 24/7 access to personalized support and encouragement, behavioral skills training for smoking cessation and medication adherence, and individually-tailored feedback on how to manage common, non-serious side-effects and nicotine withdrawal symptoms. iMAP can be accessed via personal computer or smartphone Internet browser. Given the popularity, high frequency of bothersome, non-serious medication side-effects, and increased monitoring demands for varenicline use, the pilot prototype is designed to support varenicline pharmacotherapy, but if the proposed intervention strategy proves promising, iMAP will be expanded to support nicotine replacement and bupropion use in the future. iMAP's design and content were informed by prior formative work with smokers and a team of clinical experts in medicine, clinical psychology, and pharmacy. The program will be tested in a small randomized study (n = 70) to assess users' reactions and estimate the program's potential impact on medication adherence and smoking cessation outcomes assessed over a 5 month period. [We will also interview clinicians (n ~ 50) to assess their reaction to the program's design and functionality. Outcomes from the clinician qualitative interviews and pilot trial will be shared with a clinical advisory board who will provie objective guidance about the feasibility of further developing the program and necessary program changes.] If the results prove promising, we will plan to refine the intervention as necessary and conduct a future randomized effectiveness trial to assess the program's impact on adherence, abstinence, and treatment cost-effectiveness. Findings from this work will help inform optimal ways to enhance medication adherence and, if effective, could help reduce smoking prevalence in the US, increase patient safety by addressing adverse events in a timely way, and improve treatment cost-effectiveness. Moreover, if effective, the proposed intervention model could be applied to the management of other medications (e.g., nicotine replacement, bupropion, others).

描述（由申请人提供）：每年戒烟尝试使用三种FDA批准的药物治疗之一（相反，<9％的使用行为干预措施），但较差的依从性是每种情况有充分记录的问题这些药物。例如，我们最近发现，服用Varenicline的吸烟者中有50％具有亚最佳依从性。不遵守性的行为，例如使用不一致的药物使用，服用不足和早期治疗显着破坏了治疗的效力，这可能部分解释了为什么绝大多数治疗的吸烟者复发。提高现有药物治疗并帮助更多人停止吸烟的一种方法是增强治疗依从性。当前的试点研究将从吸烟者和临床医生（即系统用户）的角度评估基于Internet的药物依从性计划（IMAP）的可行性和可接受性。 IMAP旨在促进患者和临床医生之间的持续沟通；增强不良事件监控；并提供24/7的访问权限，以获取个性化支持和鼓励，行为技能培训，以进行戒烟和药物依从性，以及有关如何管理常见，非严重的副作用和尼古丁戒断症状的单独限制的反馈。可以通过个人计算机或智能手机互联网浏览器访问IMAP。鉴于流行，高频率的，非严重的药物副作用以及对使用Varenicline使用的监控需求的增加，该试验原型旨在支持Varenicline药物治疗，但是如果提出的干预策略证明了有希望的IMAP，则将扩展以支持尼古丁的替代和安非他酮将来使用。 IMAP的设计和内容已通过吸烟者和医学，临床心理学和药房的临床专家团队的先前形成性工作告知。该程序将在一项小型随机研究（n = 70）中进行测试，以评估用户的反应，并估算该计划对5个月内评估的药物依从性和戒烟结果的潜在影响。 [我们还将采访临床医生（N〜50），以评估他们对计划设计和功能的反应。临床医生定性访谈和试点试验的成果将与临床咨询委员会共享，该委员会将证明有关进一步制定该计划和必要计划更改的可行性的客观指导。必要并进行未来的随机有效性试验，以评估该计划对依从性，禁欲和治疗成本效益的影响。这项工作的发现将有助于为增强药物依从性提供最佳方法，并有效，有助于减少美国的吸烟率，通过及时解决不良事件并提高治疗成本效益来提高患者的安全性。此外，如果有效，则建议的干预模型可以应用于其他药物的管理（例如，尼古丁替代，安非他酮，其他）。