NCT03263143已完成不适用
Early Palliative Care in the Medical Intensive Care Unit
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Change in code status to do-not-resuscitate/do-not-intubate
研究概览
简要总结
The study compares early palliative care consultation to standard of care in the medical intensive care unit (ICU). The study will assess if the intervention leads to an increased proportion of clearly delineated goals of care and examine if this intervention leads to decreased healthcare resource utilization such as length of stay, duration of intensive treatments including mechanical ventilation, and hospital re-admissions.
详细描述
- The medical intensive care unit will be split into two groups, assigned as either early palliative care consultation or standard of care. Current standard of care in the ICU is that primary clinician providers determine the need and time for palliative care consultation, which can occur approximately 5 - 14 days after admission.
- A palliative care screening tool will be used to determine if a newly admitted patient is eligible for palliative care consultation.
- Up to two patients per ICU per weekday will be enrolled into the study, due to workload limitations on the palliative care consult team.
- For patients in the intervention group, a palliative care consultation will be performed within 48 hours of ICU admission and patients will be followed throughout their hospitalization.
- Patients in the standard of care group will receive usual care. Palliative care may be consulted at the primary team's clinical discretion.
- The two medical ICU groups will be crossed over after three months with a washout period of six weeks, for a total of approximately eight months of study
- Electronic medical records will be reviewed after patient discharge to collect data on clinical outcomes as described elsewhere
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the ICU in the last 24 hours
- •Admitted from Skilled nursing facility (SNF), long term acute care (LTAC)facility, long term ventilator care (vent LTC) unit, or home care with private duty nursing with activity of daily living (ADL) dependencies
- •End-stage dementia, amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis
- •Advanced or Metastatic Cancer
- •Cardiac or respiratory arrest with neurological compromise
- •Multi- organ system failure (more than 2 organ failures)
- •Known diagnosis of end stage organ disease including cirrhosis, end-stage renal disease, congestive heart failure New York Heart Association >III, chronic obstructive pulmonary disease on home O2
- •Shock requiring > 6 hours of vasopressors or inotropes
- •Acute Respiratory failure requiring intubation or BiPAP
- •Admitted to ICU with hospital length of stay of more than 5 days or ICU readmission with the same diagnosis in 30 days.
排除标准
- •All stem cell transplant patients, for solid organ transplant, if undergoing evaluation for solid organ transplant or within 1 year post-transplant.
- •Patients who do not speak English if interpreter is unavailable
- •Patients without capacity to participate in palliative care discussions without a surrogate available
- •Patients or patient surrogate refusal of palliative care consultation
- •Prior Palliative Care Consultation during the same hospitalization
- •For purposes of primary outcome analysis, patients determined to already be DNR/DNI at time of ICU admission
研究组 & 干预措施
Standard of Care
No Intervention
Early Palliative Care Consultation
Other
干预措施: Palliative Care (Other)
结局指标
主要结局
Change in code status to do-not-resuscitate/do-not-intubate
时间窗: Through patient admission until discharge, charts reviewed an average of one month after discharge
As determined by code status orders in the electronic medical record
次要结局
- Total hospital operating cost(Through study completion, an average of 6 months)
- Hospital Length of Stay(After date of discharge, charts reviewed an average of one month after discharge)
- In-hospital mortality(After date of discharge, charts reviewed an average of one month after discharge)
- Number of participants with tracheostomy performed during hospital stay(Through study completion, an average of six months)
- Number of participants with Cardiopulmonary Resuscitation (CPR) performed(Through study completion, an average of 6 months)
- Mechanical Ventilation usage and duration(After date of discharge, charts reviewed an average of one month after discharge)
- 30-day mortality(One to two months after patient discharge, verified at study completion)
- ICU Length of Stay(After date of discharge, charts reviewed an average of one month after discharge)
- Post-discharge ER visits and/or readmissions(One to two months after patient discharge, verified at study completion)
- Hospice transition or discharge(Through patient admission until discharge, charts reviewed an average of one month after discharge)
- Vasopressor usage and duration(After date of discharge, charts reviewed an average of one month after discharge)
- Antibiotic usage and duration(After date of discharge, charts reviewed an average of one month after discharge)
- Number of participants treated with hemodialysis(Through study completion, an average of six months)
研究者
Marin Kollef
Professor, Division of Pulmonary and Critical Care Medicine
Washington University School of Medicine
研究点 (2)
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