STorytelling to Improve DiseasE outcomes in GoUT: The STRIDE-GO Study

 描述(由申请人提供)： 背景和目的：在美国，慢性疾病的低服药依从性是一个每年因过度住院而造成超过1000亿美元损失的问题。在慢性阻塞性肺疾病(COPD)、充血性心力衰竭(CHF)、痛风等慢性症状性疾病中，患者通常不知道疾病的严重性和对疾病并发症的易感性，因为严重的疾病症状是间歇性的。我们的目标是测试以患者为中心、与文化相关的叙事干预或“讲故事”的有效性，基于叙事传播理论和健康信念模式的坚实概念基础，以痛风为测试案例，提高非裔美国退伍军人对慢性病的服药依从性和结果。与白人相比，患有痛风的非裔美国人(AA)对痛风药物的依从性较低。在退伍军人事务部(VA)HSR&D试点研究计划的资助下，我们已经完成了一项强大的“讲故事”干预措施的开发和迭代修改，其中包括来自美国俄勒冈州伯明翰和宾夕法尼亚州费城的AA退伍军人对ULT忠诚度较高的信息。这一最后的干预措施已经在这些地点的目标人群中测试了可行性、可接受性、内容和叙事强度，并得到目标人群的认可。项目目标和目的：我们的长期目标是减少退伍军人的健康差距，改善他们的健康状况。这项拟议的研究的目的是评估一种新的以退伍军人自己的声音讲述故事的干预措施的有效性，以改善患有痛风的非裔美国退伍军人的服药依从性和患者预后。我们的具体目标(SA)S旨在评估讲故事干预在患有痛风的非裔美国退伍军人中的有效性，以改善：SA1：改善ULT依从性，在3、6、9个月(评估干预效果)和12个月(评估效果的持久性)时使用MEMS(药物事件监测系统)CAPS直接测量，SA2：改善痛风红斑率、患者满意度和目标血尿酸盐(SuA)和6 mg/dl成绩，作为更好的ULT依从性和重要的痛风结果的间接指标。项目方法：我们将在250名非裔美国退伍军人中进行为期12个月的多中心随机对照试验，这些退伍军人在伯明翰、圣路易斯和费城的诊所拥有80%的痛风药物。我们将比较讲故事干预和常规护理在改善ULT依从性方面的效果，在6个月时使用MEMSCaps(电子监测)进行评估(主要结果)；减少需要治疗的痛风发作，提高患者满意度，提高达到目标血尿酸盐和6 mg/dl的能力，以及改善6个月时自我报告的ULT依从性(次要结果)。我们将在12个月后评估这些结果，作为维持干预效果的证据。与退伍军人管理局的使命和优先事项保持一致：这项研究服务于退伍军人管理局改善退伍军人健康的使命，并涉及两个优先领域，1)减少医疗保健差距，2)使用低成本、基于技术的解决方案改善医疗保健服务，以解决服药依从性差的问题。研究结果将导致为痛风AA退伍军人实施低成本、以患者为中心的干预措施，以改善服药依从性和患者结果。本研究将为“讲故事”改善慢性症状性疾病用药依从性的有效性提供证据。“讲故事”干预可以很容易地适应类似的慢性症状性疾病，如慢性阻塞性肺病和慢性心力衰竭。

 DESCRIPTION (provided by applicant): Background and Objective: Low medication adherence in chronic diseases is a problem that costs over $100 billion a year in excess hospitalizations in the US. Patients often do not perceive disease severity and susceptibility to disease complications in chronic symptomatic diseases such as Chronic Obstructive Pulmonary disease (COPD), Congestive Heart Failure (CHF), gout, etc., since severe disease symptoms are intermittent. Our objective is to test the efficacy of a patient-centered, culturally relevant, narrative intervention, or "storytelling", basd on the solid conceptual foundation of the narrative communication theory and the Health Belief Model to improve medication adherence and outcomes in chronic diseases among African- American veterans, using gout as a test case. African-Americans (AAs) with gout have lower adherence to gout medications compared to Caucasians. Funded by the Veterans Affairs (VA) HSR&D pilot study program, we have completed the development and iterative modification of a powerful "storytelling" intervention consisting of messages from AA veterans with higher ULT adherence at Birmingham, AL and Philadelphia, PA. This final intervention has been tested for feasibility, acceptability, content and narrative strength in the target population at these sites and endorsed to be powerful by the target population. Project Objectives and Aims: Our long-term objective is to reduce health disparities in veterans and improve their health outcomes. The objective of the proposed study is to assess the efficacy of a novel storytelling intervention in veterans' own voices to improve medication adherence and patient outcomes in African- American veterans with gout. Our Specific Aim (SA)s are to assess the efficacy of storytelling intervention in African-American veterans with gout for improving: SA1: Improving ULT adherence, directly measured by using MEMS (Medication Event Monitoring System) Caps at 3, 6 and 9 months (assess intervention's effect) and 12 months (assess durability of effect), SA2: Improving Gout flare rate, patient satisfaction and target serum urate (sUA) <6 mg/dl achievement, as indirect measures of better ULT adherence and important gout outcomes. Project Methods: We will conduct a 12-month, multicenter, randomized controlled trial among 250 African- American veterans with gout with ULT medication possession ratio of <80% at Birmingham, St. Louis and Philadelphia VA clinics. We will compare the efficacy of the storytelling intervention to usual care in improving ULT adherence, assessed with MEMSCaps (electronic monitoring) at 6-months (primary outcome); reducing gout flares needing treatment, improving patient satisfaction, improving the ability to achieve target serum urate <6 mg/dl and improving self-reported ULT adherence at 6-months (secondary outcomes). We will assess these outcomes at 12-months as evidence for sustenance of the effect of intervention. Alignment with VA mission and priorities: This study serves the VA's mission of improving the health of veterans and addresses two priority areas, 1) decreasing health care disparities and 2) improving health care delivery using a low-cost, technology-based solution to poor medication adherence. Study results will lead to a ready-to-implement low cost patient-centered intervention for AA veterans with gout to improve medication adherence and patient outcomes. Our study will provide the proof of efficacy of "storytelling" for improving medication adherence in chronic symptomatic diseases. The "storytelling" intervention can be easily adapted for similar chronic symptomatic conditions such as COPD and CHF.