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

ICU通气患者镇静治疗自我管理的效果

基本信息

批准号：
9668181
负责人：
Linda L Chlan
金额：
$ 65.17万
依托单位：
MAYO CLINIC ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-05-01 至 2022-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9668181
关键词：
Academic Medical Centers Activities of Daily Living Acute Address Adult Adverse effects Affect Agitation Anxiety Arousal Care given by nurses Caring Chronic Client satisfaction Clinical Clinical Practice Guideline Communities Complex Critical Illness Data Analyses Delirium Dexmedetomidine Distress Equation Exposure to Financial Hardship Foundations Future Goals Graph Health Individual Intensive Care Units Intubation Judgment Knowledge Life Light Malignant Neoplasms Mechanical ventilation Mechanics Medical Medication Management Mental Depression Methods Modality Modeling Motor Motor Activity National Institute of Nursing Research Nurses Ohio Outcome Pain Patient-Focused Outcomes Patients Persons Pharmaceutical Preparations Physicians Population Post-Traumatic Stress Disorders Practice Management Quality of life Questionnaires Randomized Randomized Clinical Trials Regimen Reporting Research Research Priority Respiratory Care Units Respiratory Failure Sampling Science Sedation procedure Self Administration Self Efficacy Self Management Stress Surgical Intensive Care Symptoms Syndrome Telephone Interviews Testing Time United States Ventilator Visual Weaning Well in self Work Writing adverse outcome alertness analog anxiety management anxiety symptoms associated symptom awake base brain dysfunction cancer care care costs clinical development clinically relevant cognitive function confusion assessment method cost efficacy testing efficacy trial empowered functional status health related quality of life impaired functional status improved innovation intravenous administration mental state novel strategies palliate patient population pragmatic trial prescription opioid prevent public health relevance recruit safety and feasibility sedative side effect symptom management symptom science symptom self management treatment as usual trend

项目摘要

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.

描述（由申请人提供）：在美国，每年约有 100 万患者因呼吸衰竭而在重症监护病房 (ICU) 接受维持生命的机械通气 (MV) 重病的经济负担为 121 至 263 美元。乙/年这与每年的癌症护理费用相当。为了减少焦虑、压力并提高 MV 的耐受性，护士经常根据对觉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，但可能会产生镇静作用。严重的副作用，包括延迟断奶、精神状态变化、谵妄、延长 MV 和延长 ICU 住院时间，需要不引起严重副作用、安全并减轻痛苦的 MV 引起的症状（如焦虑）。机械通气患者 (MVP) 自我管理镇静治疗 (SMST) 可能是此类新颖策略之一，该随机对照试验旨在： 1) 确定 SMST 与护士镇静治疗 (NAST) 相比对焦虑、持续时间的疗效。 2) 与接受 NAST 的 MVP 相比，检查随机接受 SMST 的 MVP 的觉醒、警觉性和镇静剂暴露水平； 3) 比较随机接受 SMST 的 MVP 与接受 NAST 的 MVP 的 ICU 后结果将从俄亥俄州立大学医学中心的内科和外科 ICU 招募 190 名成年 MVP 样本，并将患者随机分配。使用右美托咪定 (Precedex(r)) 进行 SMST 或 NAST 的常规护理评估每天 3 次，持续长达 7 天，包括：焦虑（视觉模拟量表）、觉醒和警觉性（Richmond）。躁动-镇静量表 (RASS)）、谵妄的存在或不存在（意识混乱评估方法 - ICU (CAM-ICU)）以及所有 ICU 术后 3 个月和 6 个月的镇静药物治疗结果将通过电话访谈进行评估：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）以及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、多级混合模型和广义估计方程。该 RCT 的目标是证明 MVP 的 SMST 功效，为未来的实用有效性试验提供信息。这一新的 R01 与 NINR 的两个优先事项相一致：1) 促进急性和慢性疾病的自我管理，2) 推进症状管理的科学性。对于患有慢性病的社区居民，我们将在新人群中应用自我管理科学：重症 MVP 通过赋予 MVP 自我管理焦虑的能力，而不是依靠床边 ICU 护士来减轻这种繁重的、高度个性化的症状，从而推进症状科学。这项研究有助于实现我们研究的长期目标，即使 MVP 能够自我管理症状，以减少 ICU 获得性并发症并提高这一庞大患者群体的 ICU 后生活质量。