Pragmatic trial of behavioral interventions for insomnia in hypertensive patients

描述(由申请人提供)：失眠是一种流行的、慢性的、没有得到充分治疗的慢性疾病，与高血压(HTN)和一系列不利的健康后果等共病相关。催眠药物是有效的，而且随处可见，但它们有潜在的严重不良影响。患者和提供者更喜欢非药物治疗，如认知行为治疗失眠症(CBT-I)，它是安全、有效和持久的-但并不广泛使用。电子健康记录(EHR)用于识别患者身份的创新使用，以及能够大规模、高治疗保真度和低成本地提供认知行为干预的新技术的出现，为解决这些关键问题提供了令人兴奋的机会。为了响应RFA-HL-14-019，我们提出了一项低成本、务实、以患者为中心的随机对照试验，比较了两种基于CBT-I的失眠合并高血压(INS+HTN)干预措施与初级保健医生(PCP)的常规护理(UC)。背景将是匹兹堡大学医学中心(UPMC)的初级保健实践。参与者将是625名患有INS+HTN的成年人。招募将使用EpicCare EHR中由患者特征(高血压、催眠药物或失眠诊断/问题)触发的警报进行。我们将比较3种干预措施：包括电子教育材料和与现场干预者进行的4次电话/网络会议的失眠简要行为治疗(BBTI)；使用互联网进行健康睡眠(SHUTI)，这是CBT-I的一个自我指导的8模块互联网版本，没有人类接触；以及UC。主要结果将是在3个月时自我报告睡眠。其他结果包括通过自我报告、家庭血压监测(HBPM)和EHR获得的症状、健康和患者/提供者满意度领域。UH2阶段的具体目标是：(1)最终确定机构基础设施和(2)最终确定试验基础设施。UH3阶段的具体目标是：(1)比较3个月、6个月和12个月患者报告症状的干预措施。主要结果是3个月时的PROMIS睡眠障碍评定量表。假设：在患者报告的结果上，BBTI和CBT-I将优于UC。(2)比较干预后6个月和12个月的健康指标，包括自我报告、HBPM和EHR措施。假设：BBTI和CBT-I在每个健康结局上都优于UC。(3)比较患者和提供者对3种干预措施的满意度。假设：在患者和提供者满意度方面，BBTI和CBT-I将优于UC。(4)探索性目标：比较BBTI和CBT-I在各个结果领域和干预依从性/退出性上的差异。这项建议利用了我们在传统和互联网失眠干预方面的专业知识，与UPMC和初级保健实践的合作，以及基于EHR的招聘；它使用可扩展的筛查和治疗模型来解决重大健康问题；它评估与患者、提供者和医疗系统相关的结果；它使用创新的EHR招募战略；它将有效、低成本、可扩展、实用的睡眠干预措施整合到初级保健环境中。

DESCRIPTION (provided by applicant): Insomnia is a prevalent, chronic, and inadequately-treated chronic medical condition associated with comorbid conditions such as hypertension (HTN) and a range of adverse health outcomes. Hypnotic medications are efficacious and widely available, but they have potentially serious adverse effects. Patients and providers prefer non-drug treatments such as Cognitive-Behavioral Treatment of Insomnia (CBT-I), which is safe, efficacious, and durable-but not widely available. Innovative use of electronic health records (EHR) to identify patients, and the availability of new technologies that enable cognitive-behavioral interventions to be delivered at scale, with high treatment fidelity, and at low cost, offer exciting opportunities to address these critical problems. In response to RFA-HL-14-019, we propose a low-cost, pragmatic, patient-centered, randomized controlled trial comparing two CBT-I-based interventions for insomnia with comorbid hypertension (INS+HTN) to primary care physicians' (PCP) usual care (UC). The setting will be University of Pittsburgh Medical Center (UPMC) primary care practices. Participants will be 625 adults with INS+HTN. Recruitment will be conducted using alerts in the EpicCare EHR triggered by patient characteristics (hypertension; hypnotic medications or insomnia diagnosis/problem). We will compare 3 interventions: Brief Behavioral Treatment of Insomnia (BBTI), involving electronic educational material and 4 telephone/web sessions with a live interventionist; "Sleep Healthy Using The Internet" (SHUTi), a self-guided, 8-module, Internet version of CBT-I, with no human contact; and UC. The primary outcome will be self-reported sleep at 3 months. Other outcomes include domains of symptoms, health, and patient/provider satisfaction obtained by self-report, home blood pressure monitoring (HBPM), and EHR. Specific Aims for the UH2 phase are: (1) To finalize institutional infrastructure and (2) To finalize the trial infrastructure. Specific Aims fr the UH3 phase are: (1) To compare interventions on patient-reported symptoms at 3, 6, and 12 months. The primary outcome is the PROMIS Sleep Disturbance scale at 3 months. Hypothesis: BBTI and CBT-I will be superior to UC on patient-reported outcomes. (2) To compare interventions on health indicators including self-report, HBPM, and EHR measures at 6 and 12 months. Hypothesis: BBTI and CBT-I will be superior to UC on each health outcome. (3) To compare patient and provider-level satisfaction with the 3 interventions. Hypothesis: BBTI and CBT-I will be superior to UC on patient and provider satisfaction. (4) Exploratory Aim: To compare BBTI and CBT-I on each outcome domain and intervention adherence/drop-outs. This proposal capitalizes on our expertise in traditional and internet insomnia interventions, collaboration with UPMC and primary care practices, and EHR-based recruitment; it addresses a significant health problem using a scalable model of screening and treatment; it assesses outcomes relevant to patients, providers, and health systems; it uses an innovative EHR recruitment strategy; and it integrates efficacious, low-cost, scalable, pragmatic sleep interventions into primary care settings.