Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies

描述（由申请人提供）：患者坚持慢性治疗是有效的循证治疗和改善患者预后之间的必要联系。然而，患者经常不能坚持长期用药方案仍然是慢性病管理的最大挑战。许多研究将药物依从性与治疗失败联系起来；不必要和危险的强化治疗；以及过度的医疗费用、住院和死亡。虽然一些干预措施已被证明可以显著提高药物依从性，但所使用的策略往往是复杂的，劳动密集型的，并且效果不一。因此，旨在对基于人群的依从性做出微小但显著改善的简单干预措施可能为目前增强依从性的方法提供一种新颖、具有成本效益且易于传播的替代方案。拟议的患者（促进依从性以提高心血管疾病治疗的有效性）研究是一项实用的随机对照试验，比较两种基于卫生信息技术、低强度、低成本的人群干预措施在提高慢性心血管疾病药物依从性方面的有效性，这些药物已知可预防心血管疾病的发病率和死亡率。交互式语音识别（IVR）干预将使用自动语音识别电话，与电子病历（EMR）集成，以教育患者有关他们的药物，并帮助他们及时补充处方。增强型IVR （IVR+）干预将通过以下方式增强IVR干预：向初级保健提供者提供基于电子病历的反馈，向所有患者邮寄教育材料，以及向未按处方填写的患者发送个性化和定制的邮寄提醒。目标人群包括40-80岁患有糖尿病或流行动脉粥样硬化性心血管疾病的成年人，对他们来说，血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂（ACEI/ARB）、他汀类药物和阿司匹林都是二级预防的推荐治疗。本研究的主要目的是确定，对于他汀类药物和ACEI/ arb的当前使用者，IVR和IVR+干预是否比常规护理更能提高依从性，如果是，比较IVR与IVR+干预的相对有效性。实际稳健实施和可持续性模型（PRISM）将作为评估这些干预措施的指导框架，这些干预措施如果成功，将作为管理医疗和药房福利计划的灵活和可推广的组成部分，具有重要的公共卫生应用。

DESCRIPTION (provided by applicant): Patient adherence with chronic therapy is the necessary link between effective, evidence-based treatments and improved patient outcomes. However, the frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. Many studies have linked medication non-adherence to treatment failure; unnecessary and dangerous intensification of therapy; and excess health care costs, hospitalizations, and deaths. Although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. Simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. The proposed PATIENT (Promoting Adherence To Improve the Effectiveness of CVD Therapies) study is a pragmatic RCT to compare the effectiveness of two health information technology-based, low-intensity, low-cost population-based interventions for increasing adherence to selected chronic CVD medications with known efficacy for preventing cardiovascular morbidity and mortality. An Interactive Voice Recognition (IVR) intervention will use automated speech-recognition phone calls, integrated with an electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions in a timely manner. An Enhanced IVR (IVR+) intervention will augment the IVR intervention with: EMR-based feedback to primary care providers, mailed educational material to all patients, and personalized and tailored mailed reminders to patients who fail to fill prescriptions. The target population includes adults aged 40-80 with diabetes or prevalent atherosclerotic cardiovascular disease, for whom the use of an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker (ACEI/ARB), a statin, and aspirin are all recommended therapy for secondary prevention. The primary aims of this study are to determine if, for current users of statins and ACEI/ARBs, the IVR and IVR+ interventions lead to greater adherence compared to usual care and, if so, to compare the relative effectiveness of the IVR vs. IVR+ interventions. The Practical Robust Implementation and Sustainability Model (PRISM) will serve as the guiding framework for evaluating these interventions which, if successful, could have significant Public Health applications as flexible and generalizable components of managed care and pharmacy benefits programs. PUBLIC HEALTH RELEVANCE: The primary goal of the PATIENT study is to increase both initial use and ongoing adherence to three classes of medications used to treat diabetes or cardiovascular disease. The PATIENT interventions use interactive voice recognition, with and without supplemental personalized mailings to patients and messages to providers, to deliver medication refill reminders, educate members about their conditions, and connect members with pharmacists and their doctors. If PATIENT's methods are successful, this research should lead to reduced hospitalizations and deaths, and to increased quality of life for people with diabetes or cardiovascular disease. This research should also be broadly applicable to other diseases and treatments.