在类风湿性关节炎中实施共享决策:RAiSeD (类风湿性关节炎共享决策) 阶梯形,集群随机试验的研究协议
Jennifer L Barton1, Meike Niederhausen2, Anaïs Tuepker3
1VA Portland Health Care System, Portland, USA. Jennifer.Barton1@va.gov.
Trials
|September 30, 2025
概括
本研究评估了对类风湿性关节炎 (RA) 患者的共享决策 (SDM) 干预措施. 该干预旨在通过增强的SDM实践来改善RA疾病活动和患者知识.
科学领域:
- 类风湿病学 类风湿病学
- 医疗保健服务研究 医疗服务研究
- 临床试验方法论 临床试验方法论
背景情况:
- 类风湿性关节炎 (RA) 显著影响患者的生活质量,导致残疾和死亡率增加.
- 个人治疗决策对于RA管理至关重要,共享决策 (SDM) 是当前指南的基石.
- 低于最佳的SDM采用需要进行干预,以改善其在临床实践中的实施.
研究的目的:
- 评估多组件SDM干预对类风湿性关节炎 (RA) 疾病活动的有效性.
- 探索这个SDM干预措施在不同类型的风湿病学环境中的早期实施.
- 评估SDM对RA患者知识和药物坚持的影响.
主要方法:
- 一个渐进的,集群随机化试验设计,涉及400多名患者和45名临床医生,遍及美国退伍军人卫生管理局的3个类风湿病诊所.
- 该干预包括临床医生培训,患者激活工具 (AskShareKnow) 和护理点决策辅助工具 (RA Choice,药物总结).
- 混合方法评估包括临床结果 (临床疾病活动指数 - CDAI),患者报告的SDM措施,诊所访问的音频录音和利益相关者采访.
主要成果:
- 主要结果是通过CDAI测量疾病活动的变化.
- 二次结果包括患者对 RA 药物的了解和药物坚持.
- 过程评估将评估实施忠实性和利益相关者的经验.
结论:
- 这是第一次在多个地点进行试验,测试针对RA退伍军人的综合SDM干预措施.
- 该研究假设改善了SDM的吸收,导致RA疾病活性降低和患者知识增加.
- 结果将指导SDM在风湿病治疗中的更广泛实施,以提高患者的治疗结果.
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