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临床试验/NCT02863081
NCT02863081已完成不适用

Helping Older Persons Emerge Stronger (HOPES) After Intensive Care Unit Admission

Ohio State University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
1
主要终点
All cause mortality

研究概览

简要总结

Select Specialty, a national network of more than 100 LTACHs across the United States, has expressed the desire to adopt the ABCDEF bundle as a "standard of care" for its patients. As part of this initiative, Select first plans to conduct an ABCDEF bundle quality improvement project in one of its local hospitals. The overall purpose of this before-after study is to study prospectively the process and effects of implementing the ABCDEF bundle into the everyday care of patients requiring prolonged mechanical ventilation in the LTACH setting.

详细描述

The 300,000 chronically critically ill patients each year who require prolonged mechanical ventilation (PMV)1,2 represent an ever-growing, extremely vulnerable, proportion of intensive care unit (ICU) survivors.3 The increasing number of these patients is an important factor in the expanded use of long-term acute care hospitals (LTACHs), centers that specialize in mechanical ventilation weaning and rehabilitation. The 412 LTACHs currently operated in the United States admit more than 130,000 patients annually and account for more than $5 billion in Medicare expenditures each year.4,5 Unfortunately, LTACH stays for patients requiring PMV are typically complicated and associated with a number of poor outcomes including very high one-year mortality rates (44-77%),6,7 severe and enduring brain dysfunction (i.e., coma and/or delirium), life-altering functional decline, substantial pain and suffering, caregiver burden and diminished quality of life.6-11 While returning home is often an important goal for patients and their families,3 this is a rare outcome in this population.11 Rather, patients requiring PMV often experience multiple transitions in care in the year following their original hospital admission (median of 4), which results in further costs and persistent, profound disability.9 Despite these disheartening findings, to date there is very limited scientific evidence available to help clinicians care for the chronically critically ill, particularly those requiring PMV in LTACHs.

Chronically critically ill patients are generally older, sicker and have more comorbidities than their acutely ill counterparts.12 Importantly, they also suffer from much greater symptom burden, with up to 90% of patients experiencing at least one distressing symptom during the course of their illness (e.g., pain, dyspnea, weakness).13 While these symptoms are often thought of as unfortunate and inevitable consequences of critical illness,14 evidence suggests that the inappropriate management of these symptoms may actually be causal to the poor outcomes experienced by this group.15 For example, the results of numerous, well-designed, clinical trials conducted in the traditional ICU setting by our team and others suggest regular pain, agitation, and delirium assessment, prevention and treatment, coupled with strategies that decrease patients' exposure to sedative medications, support early mobilization, promote evidence-based mechanical ventilation discontinuation approaches, and actively engage and empower family members in patient care can positively affect important patient-centered outcomes (e.g., improved survival and physical/cognitive ability).16-26 One unifying method of implementing these evidence based interventions into everyday practice is consistent and reliable use of the ABCDEF bundle (i.e., Assess, prevent, and manage pain, Both Spontaneous Awakening Trials (SATs) & Spontaneous Breathing Trials (SBTs), Choice of analgesia and sedation, Delirium assess, prevent, and manage, Early mobility and exercise, and Family engagement and empowerment).27 Congruent with the Society of Critical Care Medicine's Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium and endorsed by a number of patient safety and quality organizations including the Institute for Healthcare Improvement and the Gordon and Betty Moore Foundation, the ABCDEF bundle is being actively implemented in ICUs throughout the world. The strength of evidence supporting the ABCDEF bundle, coupled with this strong implementation momentum, has prompted interest in the LTACH in applying the bundle into the everyday care of chronically critically ill patients who require mechanical ventilation.

Select Specialty, a national network of more than 100 LTACHs across the United States, has expressed the desire to adopt the ABCDEF bundle as a "standard of care" for its patients. As part of this initiative, Select first plans to conduct an ABCDEF bundle quality improvement project in one of its local hospitals. The overall purpose of this before-after study is to study prospectively the process and effects of implementing the ABCDEF bundle into the everyday care of patients requiring prolonged mechanical ventilation in the LTACH setting. Specifically the study's aims are to:

Aim 1: Identify facilitators and barriers to successful ABCDEF bundle implementation in the LTACH setting.

Aim 2: Compare the symptom experience (e.g., pain, agitation, anxiety, fatigue, shortness of breath, restlessness, sadness, hunger, fear, thirst, confusion sedative medication exposure) of patients receiving usual LTACH care (during months 1-4.5) to those treated with the ABCDEF bundle (during months 4.5-9).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Severe neurologic deficits defined as coma (i.e., Richmond Agitation Sedation Score < -4 or -5 due to stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic brain injury, or cerebral edema)
  • Inability to obtain informed consent from the patient's legally authorized representative (LAR) within 72 hours of meeting all inclusion criteria
  • Chronic ventilator dependence that is deemed "not weanable" by admitting LTACH physician.

结局指标

主要结局

All cause mortality

时间窗: 9 months

Pain

时间窗: 9 months

As measured by numeric rating scale of behavioral pain sclae

Facilitators/Barriers to successful ABCDEF bundle implementation in the LTACH setting

时间窗: 9 months

Achieved through surveys and focus groups of LTACH providers

次要结局

  • Tracheostomy removal(90 months)
  • Post Traumatic Stress Disorder(9 months)
  • Opioid Withdrawal(9 months)
  • Benzodiazepine Withdrawal(9 months)
  • Delirium/Coma free days(9 months)
  • Weaning duration(9 months)
  • Device self-removal(9 months)
  • Other Symptoms(9 month)
  • Anxiety Anxiety(9 months)
  • Cognitive ability(9 months)
  • Level of Arousal(9 months)
  • Depression(90 months)
  • Functional ability(9 months)
  • Quality of Life(9 months)
  • Delirium(9 months)
  • New Pneumonia(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Balas

Associate Professor College of Nursing

Ohio State University

研究点 (1)

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