Implementation of shared decision making in rheumatoid arthritis: A stepped wedge, cluster-randomized trial

类风湿关节炎共同决策的实施：阶梯楔形、整群随机试验

• 批准号: 10316959
• 负责人: Jennifer L Barton
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10316959
• 关键词: Address; Adherence; Audiotape; Awareness; Caring; Clinic; Clinical; Cluster randomized trial; Collaborations; Complex; Conflict (Psychology); Data; Decision Aid; Disease; Disease Outcome; Disease remission; Effectiveness; Enrollment; Ethnic Origin; Exposure to; Failure; Female; Fostering; Future; General Population; Goals; Guidelines; Health; Health Services; Healthcare; High Risk Woman; Intervention; Interview; Knowledge; Measures; Methodology; Methotrexate; Outcome; Participant; Patient Outcomes Assessments; Patients; Persons; Pharmaceutical Preparations; Phase; Population; Public Health; Qualitative Evaluations; Quality of Care; Quality of life; Race; Randomized Controlled Trials; Reduce health disparities; Research; Research Personnel; Rheumatoid Arthritis; Rheumatology; Site; Speed; Structure; Subgroup; Testing; Therapeutic immunosuppression; Time; Training; Translations; Treatment outcome; Veterans; Woman; Work; arthritis therapy; benefit sharing; comorbidity; design; disability; disparity elimination; disparity reduction; effective intervention; effectiveness evaluation; effectiveness study; effectiveness testing; ethnic minority; experience; health care quality; health equity; health literacy; high risk; implementation barriers; implementation facilitators; improved; indexing; innovation; intervention delivery; literacy; male; men; mortality; mortality risk; multi-component intervention; novel; novel strategies; pandemic disease; patient oriented; personalized decision; post intervention; primary outcome; racial and ethnic; routine care; secondary outcome; shared decision making; telehealth; tool; trial design; uptake; virtual delivery

Background: Rheumatoid arthritis (RA) impacts quality of life causing disability in up to 1% of the population and 2% of those 60 and older. Men with RA have twice the risk of death as the general population, in part due to higher disease activity. Despite advances in treatment options and strategies, disparities in outcomes by race/ethnicity persist. Treatment decisions after failure with first-line methotrexate are complex, involve trade- offs in terms of harm, and require individualized decisions. In shared decision making (SDM), patients and clinicians work together to identify how to best address the patient’s situation. SDM has been proposed as a way to reduce disparities, but uptake is suboptimal and no effective tools or trainings to foster SDM in a systematic, uniform way across VA exist. Significance/Impact: Veterans with RA are disproportionately male, have greater number of comorbidities, and higher mortality. SDM is the first principal of the RA treat to target guidelines but significant gaps in knowledge of effective interventions to support SDM exist – particularly in VA. This proposal to test the effectiveness of a novel, multicomponent SDM intervention is responsive to three VA HSR&D priority domains: 1) health care value (SDM is associated with reducing overuse), 2) quality of health care, and 3) health equity. Innovation: Treatment studies in RA have focused primarily on white women, while men, who represent the VA RA population, have poorer outcomes. Targeting this large subgroup to evaluate the impact of an SDM intervention on disease outcomes and adherence is novel. Use of a novel approach combining clinician training and a decision aid to recognize the unique needs of Veterans with RA is innovative. Specific Aims: Aim 1: Evaluate the effectiveness of a multi-component SDM intervention (clinician training, patient activation, RA Choice decision aid) in a stepped-wedge, cluster-randomized controlled trial on improvement in disease activity, RA knowledge, and adherence. Hypothesis 1: During SDM intervention phases, Veterans will have lower disease activity compared to during control periods and will be more likely to experience a minimally clinically important difference in a standard disease activity index. Hypothesis 2: Veterans will have higher RA knowledge and better adherence after being exposed to the intervention. Exploratory Hypothesis: The SDM intervention will have greater effect in likelihood of lowering disease activity among racial/ethnic minorities and Veterans with limited health literacy. Aim 2: Evaluate the effectiveness of a multi-component intervention to facilitate SDM. Hypothesis: An SDM intervention for Veterans with RA will result in higher uptake of SDM in enrolled clinics during the intervention phase, relative to control phase. Aim 3: Conduct a qualitative evaluation of the SDM intervention and local implementation to inform future dissemination. Methodology: A stepped-wedge, cluster-randomized controlled trial design will be used to evaluate the effectiveness of a novel SDM intervention across three sites. Participants: Veterans with RA and rheumatology clinicians; Intervention: multicomponent SDM intervention (clinician training, patient activation prompts, decision aid); Control: participants at each site during the pre-intervention period will serve as controls; Outcomes: RA disease activity; patient-reported measures of adherence, knowledge, SDM, and an objective measure of SDM. Time: pre-intervention, intervention, and post-intervention phases for each step, measures collected over 42 months. Implementation/Next Steps: The proposed effectiveness study led by an experienced, transdisciplinary team of SDM and VA health services researchers has the potential to speed the translation of SDM research within VA and beyond, through collaboration with operational partners in VISN 20 and VA subspecialists nationally to improve quality of care for all persons with RA.

背景：类风湿性关节炎 (RA) 影响生活质量，导致多达 1% 的人口残疾 60 岁及以上人群中的 2%。患有 RA 的男性死亡风险是一般人群的两倍，部分原因是 到更高的疾病活动度。尽管治疗方案和策略取得了进步，但结果仍存在差异 种族/民族依然存在。一线甲氨蝶呤失败后的治疗决策很复杂，涉及权衡 危害方面的差异，并需要个性化的决定。在共同决策 (SDM) 中，患者和 临床医生共同努力确定如何最好地解决患者的情况。 SDM 已被提议作为 减少差异的方法，但采用情况并不理想，而且没有有效的工具或培训来促进 SDM VA 存在系统、统一的方式。 意义/影响：患有 RA 的退伍军人中男性比例过高，有更多的合并症， 和更高的死亡率。 SDM 是 RA 对待目标指南的首要原则，但在 存在支持 SDM 的有效干预措施的知识——特别是在 VA 中。本提案旨在测试 一种新颖的、多成分的 SDM 干预措施的有效性取决于三个 VA HSR&D 优先领域： 1) 医疗保健价值（SDM 与减少过度使用有关），2) 医疗保健质量，以及 3) 健康公平。 创新：RA 的治疗研究主要集中在白人女性，而代表白人女性的男性 VA RA 人群的结果较差。针对这个大的子群体来评估 SDM 的影响 对疾病结果和依从性的干预是新颖的。使用结合临床医生的新方法 旨在认识 RA 退伍军人独特需求的培训和决策辅助是创新的。 具体目标： 目标 1：评估多成分 SDM 干预措施的有效性（临床医生培训、 患者激活，RA 选择决策辅助）在一项阶梯楔形、整群随机对照试验中 疾病活动度、RA 知识和依从性的改善。假设1：SDM干预期间 阶段，与控制期相比，退伍军人的疾病活动度较低，并且更有可能 在标准疾病活动指数中经历最小的临床重要差异。假设2： 退伍军人在接受干预后将拥有更高的 RA 知识和更好的依从性。 探索性假设：SDM 干预对于降低疾病活动性的可能性将产生更大的影响 健康素养有限的少数种族/族裔和退伍军人。目标 2：评估 多因素干预以促进 SDM。假设：对患有 RA 的退伍军人进行 SDM 干预将 与对照阶段相比，在干预阶段，登记诊所对 SDM 的采用率更高。目标 3： 对 SDM 干预和当地实施进行定性评估，为未来提供信息 传播。 方法：将使用阶梯楔形、整群随机对照试验设计来评估 跨三个地点的新型 SDM 干预措施的有效性。参与者：患有 RA 和风湿病的退伍军人 临床医生；干预：多成分 SDM 干预（临床医生培训、患者激活提示、 决策辅助）；对照：干预前各站点的参与者将作为对照； 结果：RA疾病活动度；患者报告的依从性、知识、SDM 和目标的测量 SDM 的测量。时间：干预前、干预和干预后各阶段、措施 收集超过 42 个月。 实施/后续步骤：拟议的有效性研究由经验丰富的跨学科团队领导 SDM 和 VA 卫生服务研究人员有潜力加快 SDM 研究的转化 VA 及其他地区，通过与 VISN 20 的运营合作伙伴和全国 VA 专科医生合作， 提高所有 RA 患者的护理质量。