Pragmatic trial of behavioral interventions for insomnia in hypertensive patients

描述（由申请人提供）：失眠是一种普遍的、慢性的、治疗不充分的慢性疾病，与高血压（HTN）等合并症和一系列不良健康结果相关。催眠药物是有效和广泛使用的，但它们有潜在的严重副作用。患者和医生更喜欢非药物治疗，如认知行为治疗失眠症（CBT-I），这是安全，有效，持久的，但不是广泛使用。电子健康记录（EHR）用于识别患者的创新使用，以及新技术的可用性，使认知行为干预能够大规模提供，治疗保真度高，成本低，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、实用、以患者为中心的随机对照试验，比较两种基于cbt - i的干预措施对失眠合并高血压（INS+HTN）和初级保健医生（PCP）常规护理（UC）的影响。设置将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。我们将比较三种干预措施：失眠的简短行为治疗（BBTI），包括电子教育材料和4个电话/网络会议与现场干预者；“网络健康睡眠”（SHUTi），自主指导的8模块网络版CBT-I，无人接触；和加州大学。主要结果将是3个月时的自我睡眠报告。其他结果包括通过自我报告、家庭血压监测（HBPM）和电子病历获得的症状、健康和患者/提供者满意度领域。UH2阶段的具体目标是：(1)完成机构基础设施；(2)完成试验基础设施。UH3阶段的具体目标是：(1)比较干预措施在3、6和12个月时对患者报告症状的影响。主要结果是3个月时的PROMIS睡眠障碍量表。假设：BBTI和CBT-I在患者报告的结果上优于UC。(2)比较干预措施在6个月和12个月的健康指标，包括自我报告、HBPM和EHR测量。假设：BBTI和CBT-I在每个健康结果上都优于UC。(3)比较3种干预措施对患者和医护人员的满意度。假设：BBTI和CBT-I在患者和提供者满意度上优于UC。(4)探索性目的：比较BBTI和CBT-I在各结果域和干预依从性/退出方面的差异。该提案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，以及基于电子病历的招聘；它利用可扩展的筛查和治疗模式处理一个重大的健康问题；它评估与患者、提供者和卫生系统相关的结果；采用创新的电子病历招聘策略；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.