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ACTIVE NOT RECRUITING

NCT04921631

Integrated Supportive and Palliative Care for Older Adults in the ICU

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Trial of Specialty Palliative Care Integrated With Critical Care for Critically Ill Older Adults

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1400

Start Date

2021-06-28

Completion Date

2026-05

Last Updated

2025-07-30

Healthy Volunteers

Conditions

Critical Illness

Interventions

BEHAVIORAL

Early Integration of Specialty Palliative Care with Critical Care

The PC team will visit the patient within 24 hours of randomization and the consultation will address the following domains of PC: illness understanding and goals of care conversations with patients/surrogates; symptom assessment and management; spiritual needs; patient and family coping and support; and care coordination and transitions. The initial family meeting will be scheduled to occur within two days of randomization. Follow-up visits will be conducted by the PC MD/APP every weekday. During this time, the ICU and PC team will be in daily communication. The PC team will continue to follow the patient in the hospital once discharged from ICU. Prior to discharge, the PC team will document patient goals and preferences for future treatment, coordinate appropriate PC services in the home and/or outpatient clinic settings and contact the patient's primary physician to provide an update on the patient's hospital stay.

Patient Inclusion Criteria 1. Admitted to a participating study ICU 2. Age greater than or equal to 60 years 3. Meets one or more of the following acute or chronic triggers for PC consultation Acute: * 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 Chronic: * 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 1. Pittsburgh Cardiac Arrest Category (PCAC) greater than or equal to 2 2. Organ support: RRT, invasive or non-invasive mechanical ventilation, vasopressors 3. Sequential Organ Failure Assessment (SOFA) score greater than or equal to 10 4. Model for End-Stage Liver Disease (MELD) greater than or equal to 30 5. Major comorbidities defined by Charlson Co-morbidity Index (CCI) 6. 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 * Age \<18 * Cannot read or understand English * Cannot complete surveys due to physical or cognitive limitations Clinician Inclusion •Patient's primary attending (or their designee)

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States