Telemedicine Management of Veterans with Chronic Insomnia and PTSD

患有慢性失眠和创伤后应激障碍的退伍军人的远程医疗管理

• 批准号: 8399318
• 负责人: SAMUEL T. KUNA
• 金额: --
• 依托单位: PHILADELPHIA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-12-01 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8399318
• 关键词: Ambulatory Care Facilities; Area; Attitude; Audiotape; Binding; Caring; Chronic; Chronic Insomnia; Clinical; Clinical effectiveness; Cognitive Therapy; Communities; Confidence Intervals; Control Groups; Data; Data Collection; Education; Effectiveness; Equipment and supply inventories; Evaluation; Focus Groups; Future; Goals; Health; Health Care Costs; Health Services Accessibility; Healthcare; Hygiene; Individual; Inferior; Intervention; Interview; Life; Manuals; Measures; Methods; Military Personnel; Modeling; Outcome; Outcome Measure; Outpatients; Participant; Patients; Perception; Persons; Pharmaceutical Preparations; Pharmacotherapy; Philadelphia; Post-Traumatic Stress Disorders; Primary Health Care; Primary Insomnia; Procedures; Protocols documentation; Provider; Psychologist; Psychotherapy; Qualitative Methods; Quality of life; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Rural; Secondary to; Severities; Sleep; Sleeplessness; Social Adjustment; Specific qualifier value; Structure; Symptoms; Telemedicine; Telephone; Testing; Therapeutic; Time; Training; Veterans; Voice; Work; Wrist; actigraphy; active control; arm; base; compare effectiveness; cost; cost effective; cost effectiveness; design; diaries; effective therapy; efficacy testing; experience; functional outcomes; group intervention; health care delivery; improved; indexing; meetings; preference; primary outcome; programs; response; rural area; satisfaction

DESCRIPTION (provided by applicant): Project Background: Most Veterans with PTSD experience chronic insomnia that has independent, negative effects on quality of life and may exacerbate other symptoms of PTSD. Cognitive behavioral therapy for insomnia (CBT-I) is highly efficacious and effective in patients with primary insomnia but the lack of clinicians trained in CBT-I limits Veterans' access to this treatment. Video teleconferencing holds the promise of increasing access to care of Veterans living in rural and remote areas. No previous studies have evaluated the delivery of CBT-I to groups of Veterans with PTSD and chronic insomnia via video teleconferencing. Project Objectives: We will conduct a randomized, controlled trial of Veterans with PTSD and chronic insomnia to compare CBT-I administered by video teleconferencing versus in-person delivery. Aim 1 will determine if CBT-I administered by video teleconferencing is not clinically inferior to in-person treatment in terms of improvement in insomnia symptoms. Aim 2 will compare the differences in cost and quality-adjusted life years between the treatment delivery approaches. Aim 3 will determine the effectiveness of CBT-I on functional outcomes, sleep quality, and non-sleep-related PTSD symptoms. Aim 4 will conduct a patient- and provider- focused formative evaluation of CBT-I delivery by video teleconferencing to assess potential barriers to its widespread implementation. Project Methods: Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC will be randomized to receive one of the following interventions in a group setting at their CBOC: 1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active control intervention. Participants will be assessed at baseline, and 2 weeks and every 3 months following the intervention. The primary outcome measure in Aim 1 will be the change in the Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods, with a pre-specified margin. Results will be ascertained via intent to treat and per-protocol procedures. We hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery. In Aim 2, VA and non- VA total healthcare costs will be collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care. Preference will be assessed by the EuroQol and Health Utilities Index 2. Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes. Aim 3 will assess the effect of CBT-I on functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the non-sleep component of the PTSD Checklist-Military). We hypothesize that these functional outcome and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 will use qualitative (targeted focus groups with participants and therapist interviews) and quantitative measures (Work Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future implementation of CBT-I by video teleconferencing. Anticipated Impacts on Veteran's Healthcare: Confirmation of the above hypotheses and the information gained from the formative evaluation will provide the evidence needed to justify clinical implementation of this telemedicine model for CBT-I delivery to Veterans with PTSD. This would significantly increase access to treatment, particularly for Veterans residing in remote and rural settings, and decrease treatment-related costs.

描述（由申请人提供）： 项目背景：大多数具有PTSD的退伍军人经历了慢性失眠，对生活质量产生独立的负面影响，并可能加剧PTSD的其他症状。失眠（CBT-I）的认知行为疗法对于原发性失眠的患者高效且有效，但是缺乏接受CBT-I训练的临床医生，从而限制了退伍军人对此治疗的机会。视频电信会议有望增加在农村和偏远地区的退伍军人的照顾。以前没有研究通过视频触发对CBT-I的赋予患有PTSD和慢性失眠的退伍军人组的CBT-I传递。项目目标：我们将对患有PTSD和慢性失眠的退伍军人进行随机对照试验，以比较视频电视转让与亲自交付的CBT-I进行比较。 AIM 1将确定通过视频触发会议管理的CBT-I是否在临床上不属于在失眠症状的改善方面临床治疗。 AIM 2将比较治疗方法之间的成本和质量调整后的终身年代差异。 AIM 3将确定CBT-I对功能结果，睡眠质量和与不良相关的PTSD症状的有效性。 AIM 4将通过视频电视转让对CBT-I交付的患者和提供者的形成性评估进行评估，以评估其广泛实施的潜在障碍。 Project Methods: Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC will be randomized to receive one of the following interventions in a group setting at their CBOC: 1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program delivered in-person, and 3) in-person提供睡眠卫生教育，这是一种已知的主动控制干预措施。干预后，将在基线，2周以及每3个月进行评估。 AIM 1中的主要结果度量将是干预后6个月的失眠严重程度指数（ISI）得分的变化。非效率分析将用于比较两种递送方法的有效性，并预先指定的边缘。将通过治疗和每项协议程序的意图确定结果。我们假设，通过视频电视会议在CBT-I之后的ISI得分的变化在临床上不如接下来的交付。在AIM 2中，将收集VA和非VA总医疗保健费用，以测试通过视频触发与亲自护理接收CBT-I的退伍军人的平均成本是否较低。优先考虑将由Euroqol和Health Utilities指数2评估。将比较视频电视连续性和亲身接触的CBT-I之间的成本和质量调整后的寿命差异，以测试视频电视连续连续性将具有较低的成本和等效性的结果。 AIM 3将评估CBT-I对功能结果的影响（短表格，工作和社会调整量表），睡眠质量（匹兹堡睡眠质量指数，睡眠日记和腕表）和PTSD严重性（PTSD清单中的非腿部组成部分）。我们假设这些功能结果和睡眠质量度量将按照每种CBT-I递送方法进行改善，并且CBT-I将改善与非腿相关的PTSD严重程度。在AIM 4中对CBT-I的远程医疗输送的形成性评估将使用定性（具有参与者和治疗师访谈的目标焦点小组）和定量措施（工作联盟库存，治疗信誉量表，流失量表），将有助于通过视频传播指导CBT-I的未来实施。对退伍军人的医疗保健的预期影响：确认上述假设以及从形成性评估中获得的信息将为CBT-I向具有PTSD提供的退伍军人提供该远程医疗模型的临床实施所需的证据。这将大大增加获得治疗的机会，特别是对于居住在偏远和农村环境中的退伍军人，并降低与治疗相关的成本。