Randomized Trial of Specialty Palliative Care Integrated with Critical Care for Critically Ill Older Adults at High Risk of Death or Severe Disability

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ABSTRACT 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. Major problems include: (1) patients frequently die with distressing symptoms, receiving more invasive, life- prolonging treatments than they would choose for themselves; (2) family members acting as surrogate decision makers experience lasting psychological distress from the ICU experience; and (3) life-prolonging treatments near the end of life contribute to high health care costs. One potential strategy to address these shortcoming for older patients at high risk of death or disability is the early integration of specialty palliative care (PC) alongside critical care. However, there have been no high-quality randomized trials assessing whether integrating specialty palliative care with standard critical care improves outcomes. We propose to address this evidence gap by conducting a mixed-methods, multi-center randomized controlled trial among 625 critically ill older adults with at least one suggested criteria for PC consultation. Patients and their surrogate decision makers will be randomized to receive either early specialty PC integrated with standard critical care or usual care, which includes timely clinician-family meetings consistent with published recommendations. In Aim 1, we will determine effects of specialty PC integrated with critical care on the co-primary outcomes of patient-centeredness of care and surrogates’ psychological distress. In Aim 2, we will determine effects of specialty PC integrated with critical care on three domains of secondary outcomes: patients’ outcomes, families’ outcomes, and health care utilization. In Aim 3, we will conduct a parallel mixed methods study to identify contexts and mechanisms that influence the efficacy of specialty PC integrated with critical care among older critically ill patients. The research is highly significant because it will determine whether a pragmatic, widely-available intervention is effective against intractable problems near the end of life for nearly one million older Americans annually. It will provide important information for healthcare systems and policy makers who are trying to determine how best to allocate the effort of specialty PC consultants. This proposal is innovative because it will provide the first high-quality evidence regarding the impact of specialty PC integrated with critical care. The work is feasible in our hands because our team of established investigators successfully has a proven record of success conducting multicenter ICU trials and has buy-in for participation from all sites.