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

背景：类风湿性关节炎(RA)影响生活质量，导致高达1%的人口残疾 60岁及以上的人中有2%。患有类风湿关节炎的男性的死亡风险是普通人群的两倍，部分原因是 更高的疾病活跃度。尽管在治疗选择和战略方面取得了进展，但 种族/民族问题依然存在。甲氨蝶呤一线失败后的治疗决定是复杂的，涉及交易- 在危害方面是错误的，并且需要个人化的决定。在共享决策(SDM)中，患者和 临床医生通力合作，以确定如何最好地解决患者的情况。SDM已被提议作为一种 减少差距的方法，但吸收是次优的，并且没有有效的工具或培训来促进 在退伍军人事务部存在着系统的、统一的方式。 意义/影响：患有类风湿关节炎的退伍军人中男性比例不成比例，合并疾病的数量更多， 以及更高的死亡率。SDM是RA治疗的第一个针对指南的原则，但在 存在支持可持续发展管理的有效干预措施的知识--特别是在退伍军人管理局。这项建议旨在测试 一种新颖的多组分SDM干预措施的有效性取决于三个VA HSR&D优先领域： 1)卫生保健价值(SDM与减少过度使用有关)，2)卫生保健质量，3)卫生公平。 创新：RA的治疗研究主要集中在白人女性身上，而男性，他们代表着 RA人群中，预后较差。瞄准这一庞大的子组以评估SDM的影响 对疾病结果和依从性的干预是新的。一种结合临床医生的新方法的使用 认识到患有类风湿关节炎的退伍军人的独特需求的培训和决策援助是创新的。 具体目标：目标1：评估多成分SDM干预的有效性(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 改善疾病活动性、RA知识和依从性。假设1：在SDM干预期间 在各个阶段，与控制期相比，退伍军人的疾病活跃度更低，而且更有可能 在标准疾病活动性指数中经历最小的临床重要性差异。假设2： 退伍军人在接受干预后会有更高的RA知识和更好的依从性。 探索性假设：SDM干预在降低疾病活动性的可能性方面将有更大的效果 在种族/族裔少数群体和健康素养有限的退伍军人中。目标2：评估 多组分干预，促进可持续发展。假设：对患有类风湿关节炎的退伍军人进行SDM干预 在干预阶段，与对照阶段相比，在登记的诊所中，SDM的摄入量更高。目标3： 对可持续发展管理干预和当地实施情况进行定性评估，以告知未来 传播。 方法：采用阶梯楔形、整群随机对照试验设计，评价 一种新的SDM干预措施在三个地点的有效性。参与者：患有RA和风湿病的退伍军人 临床医生；干预：多组件SDM干预(临床医生培训、患者激活提示、 决策辅助)；控制：干预前期间每个地点的参与者将作为控制； 结果：RA疾病活动性；患者报告的依从性、知识、SDM和目标 SDM的度量。时间：每个步骤的干预前、干预和干预后阶段，措施 在42个月内收集的。 实施/下一步：由经验丰富的跨学科团队领导的拟议有效性研究 SDM和VA卫生服务研究人员的合作有可能加快SDM研究在 通过与VISN 20中的运营合作伙伴和全国范围内的退伍军人事务部专家进行协作， 提高对所有类风湿关节炎患者的护理质量。

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.