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

背景：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%男性类风湿性关节炎患者的死亡风险是普通人群的两倍，部分原因是 更高的疾病活动。尽管在治疗选择和策略方面取得了进展， 种族/民族问题依然存在。一线甲氨蝶呤治疗失败后的治疗决定是复杂的，涉及贸易， 在伤害方面，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，以确定如何最好地解决病人的情况。SDM被提议作为一个 可持续发展机制是减少差距的一种途径，但采用情况并不理想，而且没有有效的工具或培训， 存在跨VA系统、统一的方法。 意义/影响：患有RA的退伍军人中男性比例不成比例，有更多的合并症， 和更高的死亡率SDM是RA治疗目标指南的第一个原则，但在 特别是在脆弱性和易变性领域，存在着支持可持续发展机制有效干预措施的知识。这一提议旨在测试 一种新的、多组分SDM干预措施的有效性对VA HSR&D的三个优先领域做出响应： 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：类风湿关节炎的治疗研究主要集中在白色女性，而男性，他们代表了 VA RA人群的结局较差。以这一大型分组为目标，评估可持续发展机制的影响 对疾病结果和依从性的干预是新颖的。使用一种结合临床医生的新方法 培训和决策援助，以认识到退伍军人与RA的独特需求是创新的。 具体目标：目标1：评价多组分SDM干预的有效性（临床医生培训， 患者激活，RA选择决策辅助）的阶梯楔形，随机分组对照试验， 改善疾病活动性、RA知识和依从性。假设1：SDM干预期间 与控制期相比，退伍军人的疾病活动度较低， 在标准疾病活动指数中经历最小的临床重要差异。假设二： 退伍军人将有更高的RA知识和更好的遵守后，暴露于干预。 探索性假设：SDM干预在降低疾病活动性的可能性方面具有更大的效果 在少数种族/民族和退伍军人中，健康知识有限。目标2：评估 多部门干预，以促进可持续发展机制。假设：对RA退伍军人的SDM干预将 导致相对于对照阶段，在干预阶段登记的诊所中SDM的吸收更高。目标3： 对可持续发展机制的干预措施和地方实施情况进行定性评估，以便为今后的工作提供信息 传播。 方法学：将采用逐步楔形、随机分组对照试验设计评价 在三个地点进行新的SDM干预的有效性。参与者：RA和风湿病退伍军人 临床医生;干预：多部件SDM干预（临床医生培训，患者激活提示， 控制：干预前阶段每个研究中心的参与者将作为对照; 结局：RA疾病活动;患者报告的依从性、知识、SDM和目标指标 SDM的测量。时间：每个步骤、措施的干预前、干预和干预后阶段 收集了42个月。 实施/后续步骤：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参与有可能加快SDM研究在 通过与VISN 20的业务合作伙伴和全国范围内的VA子专家合作， 提高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.