Efficacy of self-management of sedative therapy by ventilated ICU patients

 描述(由申请人提供)：在美国，每年约有100万名呼吸衰竭患者在重症监护病房(ICU)接受维持性机械通气(MV)。危重疾病造成的经济负担在121-2630亿美元/年之间 这与每年的癌症护理费用相当。为了减少焦虑、压力和提高MV的耐受性，护士经常根据对唤醒和运动活动的主观观察给患者服用各种镇静药物。虽然有时需要镇静，但它可能会有严重的副作用，包括延迟脱机、精神状态改变、精神错乱、MV延长和ICU停留时间延长。症状管理策略是需要的，不会引起严重的副作用，是安全的，并缓解痛苦的MV诱导的症状，如焦虑。机械通气患者(MVP)的镇静治疗(SMST)自我管理可能是一种新的策略。这项随机对照试验的目的是：1)确定SMST与护士镇静治疗(NAST)在MVP患者焦虑、机械通气持续时间和精神错乱方面的疗效；2)比较随机使用SMST的MVP与接受NAST的MVP的觉醒、警觉性和镇静暴露水平；以及3)探讨随机使用SMST的MVP与接受NAST的MVP之间ICU后的结果。俄亥俄哥伦布市俄亥俄州立大学医学中心的内科和外科ICU将招募190名成年MVP样本。患者将被随机分配到使用右美托咪定(Precedex(R))的SMST组或常规的NAST治疗组。每天三次的评估包括：焦虑(视觉模拟评分)、觉醒和警觉(里士满激动-镇静评分(RASS))、精神错乱的存在或缺失(迷惑评估方法-ICU(CAM-ICU))，以及所有镇静药物。ICU后3个月和6个月的结果将通过电话访谈进行评估，内容包括：身体和功能状况(Katz日常生活能力、功能活动问卷)、心理健康状况(患者健康问卷、创伤后应激障碍检查表)和与健康相关的生活质量(简表-36)。数据分析将包括图表、描述性统计、多水平混合模型和广义估计方程。这项随机对照试验的目的是通过MVP证明SMST的有效性，为未来在ICU日常实践中进行务实有效性试验提供信息。新的R01与NINR的两个优先事项保持一致：1)促进急性和慢性疾病的自我管理，以及2)促进症状管理的科学。虽然自我管理通常是为患有慢性病的社区居民保留的，但我们将在一个新的人群中应用自我管理科学：重症MVP。SMST通过赋予MVP自我管理焦虑的能力，而不是依赖床边ICU护士来缓解这种繁重的、高度个性化的症状，从而促进了症状科学的发展。这项研究有助于我们研究的长期目标，即使MVP能够自我管理其症状，以减少ICU获得性并发症，并在如此庞大的患者群体中提高ICU后的生活质量。

 DESCRIPTION (provided by applicant): Each year in the United States, approximately 1 million patients receive life-sustaining mechanical ventilation (MV) in the intensive care unit (ICU) for respiratory failure. The financial burden of critical illness ranges from $121-$263B/year which is comparable to annual cancer care costs. To reduce anxiety, stress and promote tolerance of MV, nurses frequently administer a variety of sedative medications to patients based on subjective observations of arousal and motor activity. While sedation is indicated at times, it can have serious side effects including delayed weaning, mental status changes, delirium, prolonged MV, and extended ICU stay. Symptom management strategies are needed that do not cause serious side effects, are safe and alleviate distressful MV-induced symptoms such as anxiety. Self-management of sedative therapy (SMST) by mechanically ventilated patients (MVPs) may be one such novel strategy. This RCT aims to: 1) Determine the efficacy of SMST compared to nurse-administered sedative therapy (NAST) on anxiety, duration of mechanical ventilation, and delirium in MVPs; 2) Examine level of arousal, alertness and sedative exposure in MVPs randomized to SMST compared to those MVPs receiving NAST; and, 3) Explore post-ICU outcomes between MVPs randomized to SMST compared to those receiving NAST. A sample of 190 adult MVPs will be recruited from the medical and surgical ICUs at The Ohio State University Medical Center in Columbus, OH. Patients will be randomly allocated to SMST with dexmedetomidine (Precedex(r)) or usual care of NAST. Assessments three times each day for up to 7 days include: anxiety (visual analog scale), arousal and alertness (Richmond Agitation-Sedation Scale (RASS)), delirium presence or absence (Confusion Assessment Method-ICU (CAM- ICU)), and all sedative medications. Post-ICU outcomes at 3- and 6-months will be assessed by telephone interview on: physical & functional status (Katz Activities of Daily Living, Functional Activities Questionnaire), psychological well-being (Patient Health Questionnaire, Post-traumatic Stress Disorder Checklists), and health- related quality of life (Short Form-36). Data analyses will include graphing, descriptive statistic, multi-level mixed models, and generalized estimating equations. The goal of this RCT is to demonstrate efficacy of SMST by MVPs to inform a future pragmatic effectiveness trial in day-to-day ICU practice. This new R01 is aligned with two NINR priorities: 1) promoting self-management across acute and chronic conditions, and 2) advancing the science of symptom management. While self-management is usually reserved for community-dwelling persons with chronic conditions, we will apply self-management science in a new population: critically ill MVPs. SMST advances symptom science by empowering MVPs to self-manage anxiety rather than relying on bedside ICU nurses to palliate this burdensome, highly individual symptom. This study contributes to the long- term goals of our research which are to empower MVPs to self-manage their symptoms in order to reduce ICU- acquired complications and promote post-ICU quality of life in this large patient population.