Randomized Trial of Specialty Palliative Care Integrated With Critical Care for Critically Ill Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,091
- 试验地点
- 2
- 主要终点
- Patient and family centeredness of care
研究概览
简要总结
The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually, or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision makers often experience lasting psychological distress from the ICU experience. The investigators will conduct a randomized trial among 500 patients and 750 surrogates and up to 150 clinicians to determine whether early integration of specialty palliative care with standard critical care can improve outcomes for critically ill older patients at high risk of death or severe functional impairments and their family members.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to a participating study ICU
- •Age greater than or equal to 60 years
- •Meets one or more of the following acute or chronic triggers for PC consultation
- •Cardiac or respiratory arrest with coma
- •Ischemic or hemorrhagic stroke requiring mechanical ventilation
- •ICU admission after hospital stay of greater than or equal to 10 days or ICU readmission within 30 days
- •Age greater than or equal to 80 and 1 or more forms of organ support
- •Multiorgan system failure
- •CCM physician judgment of greater than or equal to 50% risk of in-hospital death or new severe long term functional impairment
- •Admission from a SNF or LTACH with progressive functional decline
- •Metastatic (stage IV) cancer or advanced cancer without curative treatment
- •End stage cardiorespiratory disease
- •End stage liver disease
- •Advanced dementia or other end-stage neurologic disease
- •Age greater than or equal to 80 with two or more major comorbidities
- •Moderate-severe frailty (excluding stable intellectual or physical disability
- •Pittsburgh Cardiac Arrest Category (PCAC) greater than or equal to 2
- •Organ support: RRT, invasive or non-invasive mechanical ventilation, vasopressors
- •Sequential Organ Failure Assessment (SOFA) score greater than or equal to 10
- •Model for End-Stage Liver Disease (MELD) greater than or equal to 30
- •Major comorbidities defined by Charlson Co-morbidity Index (CCI)
- •Clinical Frailty Scale (CFS) score greater than or equal to 6
- •Patient Exclusion
- •No surrogate decision maker
- •Already received (or refused) a Palliative Care consultation during the same hospitalization
- •Determined to be imminently dying (within hours) by CCM physician
- •Within 1 year of receiving organ transplant, or actively undergoing work-up for organ transplant
- •Non-English speaking
- •Surrogate Inclusion
- •Primary surrogate, as determined by the patient's advance directive or by the hierarchy codified in state law
- •Up to 3 additional surrogates
- •Surrogate Exclusion
- •Cannot read or understand English
- •Cannot complete surveys due to physical or cognitive limitations
- •Clinician Inclusion
- •Patient's primary attending (or their designee)
排除标准
- 未提供
研究组 & 干预措施
Intervention
The intervention arm will receive early specialty palliative care integrated with standard critical care.
干预措施: Early Integration of Specialty Palliative Care with Critical Care (Behavioral)
No intervention
Usual ICU care; each study ICU has a policy for family meetings within 72 hours of admission and at least weekly thereafter.
结局指标
主要结局
Patient and family centeredness of care
时间窗: Measured at 3 months after hospital discharge
12-item Patient Perceived Patient-Centeredness of Care Scale (PPPC), previously modified for use by surrogates, completed at 3-month telephone follow-up of surrogates.
次要结局
- Unmet palliative care needs(Measured at day 5 post-randomization)
- Surrogates' clarity about patient values and preferences(Measured on study day 5)
- Duration of mechanical ventilation(Measured at 6 months)
- Composite measure of goal-concordant care(Measured at 3 months)
- Satisfaction with ICU care(Measured at 3 months)
- Risk of post-traumatic stress disorder(Measured at 6 months)
- Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care during index hospitalization(Measured at 6 months)
- Surrogates' prognostic awareness(Measured on study day 5)
- Symptoms of anxiety and depression(Measured at 6 months)
- Cost of index hospitalization(Measured at 6 months)
- Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization(Measured at 6 months)
- Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization(Measured at 6 months)
- ICU and hospital length of stay(Measured at 6 months)
- Resource utilization over 6-months follow-up(Measured at 3 months and 6 months)
研究者
Douglas White
Professor
University of Pittsburgh