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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：
9008858
负责人：
Linda L Chlan
金额：
$ 62.13万
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 2021-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9008858
关键词：
Academic Medical Centers Activities of Daily Living Acute Address Adult Adverse effects Affect Agitation Anxiety Arousal Caring Chronic Client satisfaction Clinical Practice Guideline Communities Complex Critical Illness Data Analyses Delirium Development Dexmedetomidine Distress Equation Future Goals Graph Health Individual Intensive Care Units Intravenous Intubation Judgment Knowledge Life Light Malignant Neoplasms Mechanical ventilation Mechanics Medical Mental Depression Methods Modality Modeling Motor Motor Activity National Institute of Nursing Research Nurses Ohio Opioid Outcome Pain Patient-Focused Outcomes Patients Personal Satisfaction Persons Pharmaceutical Preparations Physicians Population Post-Traumatic Stress Disorders Quality of life Questionnaires Randomized Randomized Clinical Trials Recruitment Activity Regimen Reporting Research Research Priority Respiratory Failure Safety Sampling Science Sedation procedure Self Administration Self Management Stress Surgical Intensive Care Symptoms Syndrome Telephone Interviews Testing Time United States Ventilator Visual Weaning Work Writing alertness analog anxiety symptoms associated symptom awake base brain dysfunction cancer care clinically relevant cognitive function confusion assessment method cost effectiveness trial efficacy testing efficacy trial empowered functional status health related quality of life impaired functional status improved innovation intravenous administration mental state novel strategies patient population prevent psychologic public health relevance respiratory sedative statistics 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.