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

讲故事可改善痛风的疾病结果：STRIDE-GO 研究

• 批准号: 9085817
• 负责人: Jasvinder A Singh
• 金额: --
• 依托单位: BIRMINGHAM VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9085817
• 关键词: Accident and Emergency department; Accident and Emergency department; Achievement; Achievement; Acute; Acute; Address; Address; Adherence; Adherence; Adoption; Adoption; Affect; Affect; African; African; African American; African American; Alcohol consumption; Alcohol consumption; Area; Area; Attention; Blood Pressure; Blood Pressure; Body mass index; Body mass index; Caring; Caring; Caucasians; Caucasians; Chronic; Chronic; Chronic Disease; Chronic Disease; Chronic Obstructive Airway Disease; Chronic Obstructive Airway Disease; Client satisfaction; Client satisfaction; Clinic; Clinic; Clinical; Clinical; Clinical Trials; Clinical Trials; Communication; Communication; Computers; Computers; Congestive Heart Failure; Congestive Heart Failure; Cues; Cues; Data; Data; Databases; Databases; Development; Development; Disease; Disease; Disease Outcome; Disease Outcome; Disease susceptibility; Disease susceptibility; Effectiveness; Effectiveness; Electronics; Equilibrium; Event; Event; Flare; Flare; Foundations; Foundations; Funding; Funding; Gout; Gout; Guidelines; Health; Health; Hospitalization; Hospitalization; Hospitals; Hospitals; Hypertension; Inflammatory Arthritis; Inflammatory Arthritis; Inpatients; Inpatients; Interruption; Intervention; Intervention; Intervention Studies; Intervention Studies; Intuition; Knowledge; Knowledge; Lead; Lead; Measures; Measures; Medical Care Costs; Medical Care Costs; Methods; Methods; Mission; Mission; Modeling; Modeling; Modification; Modification; Monitor; Monitor; Nature; Nature; Outcome; Outcome; Pain; Pain; Patient Self-Report; Patient Self-Report; Patient-Focused Outcomes; Patient-Focused Outcomes; Patients; Patients; Pharmaceutical Preparations; Pharmaceutical Preparations; Philadelphia; Philadelphia; Pilot Projects; Pilot Projects; Psychological reinforcement; Psychological reinforcement; Publishing; Publishing; Randomized; Randomized; Randomized Controlled Trials; Randomized Controlled Trials; Research; Research; Research Priority; Research Priority; Risk; Risk; Serum; Serum; Severity of illness; Severity of illness; Site; Site; Solid; Solid; Surveys; Surveys; Symptoms; Symptoms; System; System; Target Populations; Target Populations; Technology; Technology; Telephone; Telephone; Testing; Testing; Time; Time; Treatment Efficacy; Treatment Efficacy; Urate; Urate; Veterans; Veterans; Visit; Visit; Voice; Voice; attentional control; base; base; communication theory; communication theory; comparative efficacy; comparative efficacy; cost; cost; disability; disability; efficacy testing; efficacy testing; health belief; health belief; health care delivery; health care delivery; health care disparity; health care disparity; health care service utilization; health care service utilization; health disparity; health disparity; health related quality of life; health related quality of life; improved; improved; improved outcome; improved outcome; insight; insight; intervention effect; intervention effect; joint destruction; joint destruction; medication compliance; medication compliance; novel; novel; patient engagement; patient oriented; patient oriented; patient-level barriers; persistent symptom; persistent symptom; primary outcome; primary outcome; programs; programs; research study; research study; secondary outcome; secondary outcome; stress management; stress management; success; success; therapy adherence; therapy adherence; touchscreen; touchscreen; treatment as usual; treatment as usual; treatment guidelines

 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.

 描述（由申请人提供）： 背景和目的：慢性疾病的药物依从性低是一个问题，每年在美国因过度住院而造成的损失超过 1000 亿美元。对于慢性阻塞性肺疾病（COPD）、充血性心力衰竭（CHF）、痛风等慢性症状性疾病，由于严重的疾病症状是间歇性的，患者往往意识不到疾病的严重程度和对疾病并发症的易感性。我们的目标是基于叙事沟通理论和健康信念模型的坚实概念基础，以痛风作为测试案例，测试以患者为中心、文化相关的叙事干预或“讲故事”的有效性，以提高非裔美国退伍军人慢性病的药物依从性和结果。与白人相比，患有痛风的非洲裔美国人 (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，我们完成了强大的“讲故事”干预措施的开发和迭代修改，其中包括来自阿拉巴马州伯明翰和宾夕法尼亚州费城的 ULT 遵守率较高的 AA 退伍军人的信息。最终的干预措施已经在这些地点的目标人群中进行了可行性、可接受性、内容和叙述强度的测试，并得到了目标人群的认可。项目目标和目标：我们的长期目标是减少退伍军人的健康差异并改善他们的健康状况。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声音的效果，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果。我们的具体目标 (SA) 是评估讲故事干预对患有痛风的非裔美国退伍军人的改善效果：SA1：提高 ULT 依从性，通过使用 MEMS（药物事件监测系统）上限在 3、6 和 9 个月（评估干预效果）和 12 个月（评估效果的持久性）直接测量，SA2：提高痛风发作率、患者满意度和目标血清尿酸 (sUA) <6 mg/dl 成就，作为更好的 ULT 依从性和重要痛风结局的间接衡量标准。项目方法：我们将在伯明翰、圣路易斯和费城退伍军人管理局诊所对 250 名患有痛风且 ULT 药物拥有率 <80% 的非裔美国退伍军人进行一项为期 12 个月的多中心随机对照试验。我们将比较讲故事干预与常规护理在提高 ULT 依从性方面的功效，并在 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，提高实现血清尿酸<6 mg/dl 目标的能力，并提高自我报告的 6 个月 ULT 依从性（次要结果）。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。与退伍军人事务部的使命和优先事项保持一致：这项研究服务于退伍军人事务部改善退伍军人健康的使命，并解决两个优先领域：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。研究结果将为患有痛风的 AA 退伍军人提供准备实施的低成本、以患者为中心的干预措施，以提高药物依从性和患者治疗结果。我们的研究将证明“讲故事”对于改善慢性症状性疾病的药物依从性的有效性。 “讲故事”干预可以很容易地适应类似的慢性症状，如慢性阻塞性肺病和慢性心力衰竭。