Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and Therapy for Sleep (OATS) randomized trial design
Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and Therapy for Sleep (OATS) randomized trial design
复制标题
DOI：
10.1016/j.cct.2019.105851
复制
发表时间：
2019-12-01
影响因子：
2.2
通讯作者：
Vitiello, Michael V.
中科院分区：
文献类型：
--
作者：
McCurry, Susan M.;Von Korff, Michael;Vitiello, Michael V.
骨关节炎和睡眠治疗（OATS）研究是一项基于人群的失眠认知行为治疗（CBT-I）随机对照试验，具有四个创新方法学目标。这些目标是：（1）招募华盛顿州的代表性参与者，包括来自医疗服务不足社区的参与者;（2）招募患有持续性失眠和慢性骨关节炎（OA）疼痛的人;（3）测试可扩展的CBT-I干预;（4）评估患者报告的结果（失眠，疼痛严重程度，疲劳，抑郁）和一年的成本效益。本文件介绍了在实现这些目标方面取得的进展。目标人群为在Kaiser Permanente华盛顿（KPW）医疗保健系统内接受OA治疗的60岁以上患者。我们采用了两阶段的筛选，通过邮件调查和电话随访，屏幕之间的间隔为3周，以排除自发改善睡眠或疼痛症状的人。参与者被随机分配到6个会话的电话提供CBT-I干预或6个会话的电话教育仅控制条件（EOC）。盲法结局评估（在线或邮寄纸质表格完成）包括主要和次要睡眠和疼痛结局指标以及生活质量指标。我们从行政索赔数据中获得了医疗保健利用率。将进行意向治疗分析，包括所有在安排第一次电话会议时随机分配的受试者，以比较CBT-I和EOC结局。该试验将是迄今为止对电话CBT-I进行的最大规模的实验性评估，也是第一次评估其成本效益。
The OsteoArthritis and Therapy for Sleep (OATS) study is a population-based randomized controlled trial of cognitive behavioral therapy for insomnia (CBT-I) with four innovative methodological aims. These are to: (1) Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3) Test a scalable CBT-I intervention; and (4) Evaluate patient-reported outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness over one year. This paper describes progress towards achieving these aims. The target population was persons age 60 + who had received OA care within the Kaiser Permanente Washington (KPW) health care system. We employed a two-phase screening via mail survey and telephone follow-up, with a 3-week interval between screens to exclude persons with spontaneous improvement in sleep or pain symptoms. Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC). Blinded outcome assessments (completed online or on mailed paper forms) included primary and secondary sleep and pain outcome measures and quality of life measures. We obtained healthcare utilization from administrative claims data. Intent to treat analyses, including all participants randomized when they scheduled the first telephone session, will be conducted to compare CBT-I and EOC outcomes. The trial will be the largest experimental evaluation of telephone CBT-I to date, and the first to evaluate its cost-effectiveness.