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

 描述（由申请人提供）： 背景和目的：慢性病的低药物依从性是一个问题，在美国每年花费超过1000亿美元的过度住院治疗。在慢性症状性疾病如慢性阻塞性肺疾病（COPD）、充血性心力衰竭（CHF）、痛风等中，患者通常不感知疾病严重程度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的，文化相关的，叙事干预或“讲故事”的有效性，基于叙事沟通理论和健康信念模型的坚实概念基础，以改善非裔美国退伍军人慢性疾病的药物依从性和结果，使用痛风作为测试案例。非裔美国人（AAs）痛风患者对痛风药物的依从性低于白人。由退伍军人事务部（VA）HSR&D试点研究计划资助，我们已经完成了一个强大的“讲故事”干预的开发和迭代修改，其中包括来自伯明翰，AL和费城，PA的AA退伍军人的信息。已在这些研究中心的目标人群中对最终干预措施的可行性、可接受性、内容和叙述强度进行了测试，并得到了目标人群的认可。项目目标和宗旨：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。这项拟议研究的目的是评估一种新颖的讲故事干预退伍军人自己的声音的疗效，以改善患有痛风的非裔美国退伍军人的药物依从性和患者结局。我们的具体目标（SA）是评估在患有痛风的非裔美国退伍军人中进行讲故事干预的疗效，以改善：SA 1：改善患者的依从性，直接通过使用MEMS测量（用药事件监测系统）第3、6和9个月时的上限（评估干预效果）和12个月（评估效果的持久性），SA 2：改善痛风发作率、患者满意度和目标血清尿酸盐（sUA）<6 mg/dl的实现，作为更好的药物依从性和重要痛风结局的间接指标。项目方法：我们将在伯明翰、圣路易斯和费城VA诊所的250名非裔美国退伍军人中进行一项为期12个月的多中心随机对照试验，这些退伍军人患有痛风，药物拥有率<80%。我们将比较讲故事干预与常规护理在改善6个月时的抗痛风依从性（主要结局）、减少需要治疗的痛风发作、提高患者满意度、提高达到目标血清尿酸盐<6 mg/dl的能力以及改善6个月时自我报告的抗痛风依从性（次要结局）方面的疗效。我们将在12个月时评估这些结果，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的一致性：本研究服务于退伍军人管理局改善退伍军人健康的使命，并解决了两个优先领域，1）减少医疗保健差距和2）改善医疗保健提供使用低成本，基于技术的解决方案，以改善药物依从性。研究结果将为患有痛风的AA退伍军人提供一种易于实施的低成本以患者为中心的干预措施，以改善药物依从性和患者结局。我们的研究将为“讲故事”改善慢性症状性疾病的药物依从性提供有效性证据。“讲故事”干预可以很容易地适用于类似的慢性症状，如慢性阻塞性肺病和CHF。

 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.