Use of Automated Phone Calls to Promote Adherence with Inhaled Corticosteroids

描述（由申请人提供）：在医学文献中，患者未能遵守医生开的慢性药物治疗方案已经有了很好的记录。在包括高血压、哮喘和充血性心力衰竭在内的多种慢性疾病中，均表现出较差的依从性。这种不依从性的临床含义可能包括治疗失败、不必要和危险的强化治疗、住院和死亡。世界卫生组织最近的一份报告得出结论，治疗不依从性对疾病发病率、生活质量降低和卫生保健使用率增加有很大的影响。本研究的目的是测试使用语音识别（SR）软件进行电话外联的有效性，以提高患有哮喘或慢性阻塞性肺疾病（COPD）的大型健康维护组织成员对吸入皮质类固醇（ICS）的依从性。主要结果将是药物获取的持续测量和药物缺口的持续测量。次要结局指标包括自我评估的药物使用模式、疾病特异性健康状况、对护理的满意度、哮喘/慢性阻塞性肺病医院服务的使用情况以及哮喘/慢性阻塞性肺病急性护理的总费用。这项随机临床试验将招募Kaiser Permanente西北和夏威夷地区的大约24,500名18岁或以上的成员，他们将被视为哮喘或COPD，并在随机化之前的一年中至少接受过一次呼吸药物的分配。参与者将在患者水平上随机分组，接受常规治疗或基于sr的干预，以提高对ICS药物的依从性。随机化将在最初的14个月的开发阶段之后进行，在此期间，干预脚本被开发、试验和最终确定。干预将在随机化后持续一年。相关性：这项研究的目的是测试电话语音识别软件，以改善哮喘和长期肺病患者服药的情况。如果这种方法能帮助人们按处方服药，那么它也可以用于治疗其他各种长期疾病。

DESCRIPTION (provided by applicant): The failure of patients to adhere to physician-prescribed chronic medication regimens has been well- documented in the medical literature. Poor adherence has been demonstrated across a wide range of chronic conditions, including hypertension, asthma, and congestive heart failure. The clinical implications of this non-adherence can include treatment failure, unnecessary and dangerous intensification of therapy, hospitalizations, and deaths. A recent report of the World Health Organization concluded that therapy non- adherence contributes substantially to disease morbidity, reduced quality of life, and increased health care utilization. The objective of this research is to test the effectiveness of conducting telephone outreach using speech recognition (SR) software to improve adherence to inhaled corticosteroids (ICS) among members of a large health maintenance organization with asthma or chronic obstructive pulmonary disease (COPD). The primary outcomes will be the continuous measure of medication acquisition and the continuous measure of medication gaps. Secondary outcome measures include self-assessed patterns of medication use, disease- specific health status, satisfaction with care, use of hospital-based services for asthma/COPD, and total cost of acute care for asthma/COPD. This randomized clinical trial would enroll the estimated 24,500 members of the Kaiser Permanente Northwest and Hawaii regions aged 18 years or older who will have been seen for asthma or COPD and received at least one dispensing of a breathing medication during the year prior to randomization. Participants will be randomized at the patient level to receive either usual care or an SR-based intervention designed to promote improved adherence to ICS medications. Randomization will occur after an initial 14- month development phase during which the intervention scripts are developed, piloted, and finalized. The intervention will continue for one year post randomization. Relevance: The goal of this research is to test speech recognition software for telephone calls to improve how patients take medications for asthma and long-term lung disease. This method, if it helps people take their medications as prescribed, could be used with a variety of other long-term medical conditions.