Pragmatic trial of behavioral interventions for insomnia in hypertensive patients

高血压患者失眠行为干预的实用性试验

• 批准号: 8792640
• 负责人: Daniel J. Buysse
• 金额: $ 55.58万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-19 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8792640
• 关键词: Address; Adherence; Adult; Adverse effects; Agreement; Alcohol or Other Drugs use; Anxiety; Behavior Therapy; Blood Pressure; Cardiovascular Diseases; Caring; Characteristics; Chronic; Clinical Trials; Cognitive Therapy; Collaborations; Community Medicine; Conscious; Consent Forms; Data; Data Collection; Diagnosis; Drops; Educational Materials; Electronic Health Record; Electronics; Fatigue; Feedback; Health; Health Care Costs; Health system; Healthcare; Home Blood Pressure Monitoring; Home environment; Human; Hypertension; Impaired health; Institutional Review Boards; Internet; Intervention; Life; Location; Manuals; Measures; Medical; Medical center; Mental Depression; Modeling; Monitor; Online Systems; Outcome; Outcome Measure; Participant; Patient Education; Patient Outcomes Assessments; Patient Self-Report; Patients; Pharmaceutical Preparations; Phase; Physicians' Offices; Primary Care Physician; Primary Health Care; Protocols documentation; Provider; Quality Indicator; Randomized; Randomized Controlled Trials; Recruitment Activity; Reporting; Research; Research Infrastructure; Research Personnel; Resources; Risk; Sleep; Sleep disturbances; Sleeplessness; Symptoms; Telephone; Testing; Time; Treatment outcome; Universities; base; brief intervention; cost; experience; health care service utilization; health related quality of life; hypnotic; innovation; mortality; new technology; nondrug therapy; novel; patient oriented; pragmatic trial; primary care setting; primary outcome; response; satisfaction; screening; secondary outcome; tool; treatment as usual; trial comparing

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.

描述（由申请人提供）：胰岛素抵抗是一种流行的、慢性的、治疗不充分的慢性疾病，与高血压（HTN）等共病和一系列不良健康结局相关。催眠药物是有效的，广泛使用，但它们有潜在的严重不良反应。患者和提供者更喜欢非药物治疗，如认知行为治疗（CBT-I），这是安全的，有效的，持久的，但不是广泛使用。创新性地使用电子健康记录（EHR）来识别患者，以及新技术的可用性，使认知行为干预能够以高治疗保真度和低成本大规模提供，为解决这些关键问题提供了令人兴奋的机会。作为对RFA-HL-14-019的回应，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，将两种基于CBT-I的失眠伴高血压（INS+HTN）干预措施与初级保健医生（PCP）的常规护理（UC）进行比较。该设置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。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）触发的警报进行招募。我们将比较3种干预措施：简易行为治疗（BBTI），包括电子教育材料和4个电话/网络会议与现场干预;“使用互联网的健康睡眠”（SHUTi），一个自我指导，8个模块，CBT-I的互联网版本，没有人类接触;和UC。主要结果将是3个月时自我报告的睡眠。其他结果包括症状，健康和患者/提供者满意度的领域，通过自我报告，家庭血压监测（HBPM）和EHR获得。UH 2阶段的具体目标是：（1）完成体制基础设施;（2）完成试验基础设施。UH 3阶段的具体目的是：（1）比较3、6和12个月时对患者报告症状的干预。主要结局是3个月时的PROMIS睡眠障碍量表。假设：在患者报告的结局方面，BBTI和CBT-I将上级优于UC。(2)比较干预措施对健康指标的影响，包括6个月和12个月时的自我报告、HBPM和EHR测量。假设：BBTI和CBT-I在每个健康结局上都上级UC。(3)比较患者和提供者对3种干预措施的满意度。假设：BBTI和CBT-I在患者和提供者满意度方面上级UC。(4)探索性目的：比较BBTI和CBT-I在每个结局领域和干预依从性/脱落率方面的差异。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EHR的招聘;它使用可扩展的筛查和治疗模型解决了一个重大的健康问题;它评估了与患者，提供者和卫生系统相关的结果;它使用了创新的EHR招聘策略;它将有效的、低成本的、可扩展的、实用的睡眠干预整合到初级保健环境中。