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100万例患者因呼吸衰竭在重症监护室（ICU）接受维持生命的机械通气（MV）。重大疾病的经济负担范围为1210亿美元至2630亿美元/年 这相当于每年的癌症护理费用。为了减少焦虑，压力和促进MV的耐受性，护士经常根据唤醒和运动活动的主观观察对患者施用各种镇静药物。虽然有时需要镇静，但它可能有严重的副作用，包括延迟脱机，精神状态变化，谵妄，MV延长和ICU停留时间延长。需要不引起严重副作用、安全并减轻MV引起的痛苦症状（如焦虑）的症状管理策略。自我管理的镇静治疗（SMST）的机械通气患者（MVP）可能是这样一种新的策略。本RCT旨在：1）确定SMST与护士给予的镇静治疗（NAST）相比对MVP的焦虑、机械通气持续时间和谵妄的疗效; 2）检查随机分配至SMST的MVP与接受NAST的MVP相比的觉醒、警觉和镇静暴露水平; 3）探索随机分配至SMST的MVP与接受NAST的MVP之间的ICU后结局。将从位于俄亥俄州哥伦布的俄亥俄州州立大学医学中心的内科和外科ICU招募190名成人MVP样本。患者将被随机分配至SMST+右美托咪定（Precedex（r））或NAST常规治疗组。每天三次评估，持续最多7天，包括：焦虑（视觉模拟量表）、觉醒和警觉（里士满激动-镇静量表（RASS））、是否存在谵妄（意识模糊评估方法-ICU（CAM-ICU））和所有镇静药物。将通过电话访谈评估ICU后3个月和6个月的结局：身体和功能状态（Katz日常生活活动、功能活动问卷）、心理健康（患者健康问卷、创伤后应激障碍检查表）和健康相关生活质量（简表-36）。数据分析将包括绘图、描述性统计、多水平混合模型和广义估计方程。本RCT的目的是通过MVP证明SMST的有效性，为未来在ICU日常实践中的实用有效性试验提供信息。新的R 01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，2）推进症状管理科学。虽然自我管理通常是为社区居住的慢性病患者保留的，但我们将在一个新的人群中应用自我管理科学：重症MVP。SMST通过授权MVP自我管理焦虑而不是依赖床边ICU护士来缓解这种负担沉重的，高度个性化的症状来推进症状科学。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，并提高这一庞大患者人群的ICU后生活质量。

 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.