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：大多数患有创伤后应激障碍的退伍军人经历慢性失眠，对生活质量有独立的负面影响，并可能加剧创伤后应激障碍的其他症状。失眠的认知行为疗法（CBT-I）对原发性失眠患者非常有效，但缺乏接受过CBT-I培训的临床医生限制了退伍军人接受这种治疗。视频电话会议有望增加生活在农村和偏远地区的退伍军人获得护理的机会。以前没有研究评估CBT-I通过视频电话会议向患有PTSD和慢性失眠症的退伍军人群体提供。项目目标：我们将对患有PTSD和慢性失眠症的退伍军人进行一项随机对照试验，以比较通过视频电话会议与亲自交付的CBT-I。目标1将确定通过视频电话会议进行的CBT-I在改善失眠症状方面是否在临床上不劣于面对面治疗。目标2将比较不同治疗方法之间的成本和质量调整生命年的差异。目标3将确定CBT-I对功能结果，睡眠质量和非睡眠相关的PTSD症状的有效性。目标4将通过视频电话会议对CBT-I的交付进行以患者和提供者为中心的形成性评价，以评估其广泛实施的潜在障碍。项目方法：在费城VAMC附属的社区门诊诊所（CBOC）接受初级护理的患有创伤后应激障碍和慢性失眠症的退伍军人将被随机分配到CBOC的一组环境中接受以下干预措施之一：1）通过视频电话会议提供的基于手册的CBT-I程序，2）亲自提供的CBT-I程序，以及3）亲自提供睡眠卫生教育，已知的主动控制干预。将在基线、干预后2周和每3个月对参与者进行评估。目标1中的主要结局指标是干预后6个月时的胰岛素严重程度指数（ISI）评分变化。将使用非劣效性分析比较两种输送方法的有效性，并预先规定界值。将通过意向治疗和符合方案程序确定结果。我们假设通过视频电话会议进行CBT-I后ISI评分的变化在临床上不会劣于亲自分娩。在目标2中，将收集VA和非VA总医疗保健成本，以测试通过视频电话会议接受CBT-I的退伍军人的平均成本是否低于亲自护理。偏好将通过EuroQol和健康效用指数2进行评估。将比较通过视频电话会议和面对面接触CBT-I节省的成本和质量调整生命年比率的差异，以检验视频电话会议具有较低成本和等效结果的假设。目标3将评估CBT-I对功能结局（简表-12，工作和社会适应量表），睡眠质量（匹兹堡睡眠质量指数，睡眠日记和腕关节活动记录）和PTSD严重程度（PTSD检查表的非睡眠部分-军事）的影响。我们假设，这些功能结果和睡眠质量的措施将改善以下每一种方法的CBT-I交付和CBT-I将改善非睡眠相关的PTSD的严重程度。在目标4中，对CBT-I远程医疗交付的形成性评价将使用定性（有参与者和治疗师访谈的目标焦点小组）和定量措施（工作联盟清单，治疗可信度量表，自然减员），这将有助于指导未来通过视频电话会议实施CBT-I。对退伍军人医疗保健的预期影响：上述假设的确认和从形成性评估中获得的信息将提供必要的证据，以证明临床实施CBT-I向患有PTSD的退伍军人提供远程医疗模型的合理性。这将大大增加获得治疗的机会，特别是居住在偏远和农村地区的退伍军人，并减少与治疗有关的费用。