Randomized Trial of Specialty Palliative Care Integrated With Critical Care for Critically Ill Older Adults
Overview
- Phase
- Not Applicable
- Intervention
- Early Integration of Specialty Palliative Care with Critical Care
- Conditions
- Critical Illness
- Sponsor
- University of Pittsburgh
- Enrollment
- 1091
- Locations
- 2
- Primary Endpoint
- Patient and family centeredness of care
- Status
- Completed
- Last Updated
- yesterday
Overview
Brief 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.
Investigators
Douglas White
Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention
The intervention arm will receive early specialty palliative care integrated with standard critical care.
Intervention: Early Integration of Specialty Palliative Care with Critical Care
No intervention
Usual ICU care; each study ICU has a policy for family meetings within 72 hours of admission and at least weekly thereafter.
Outcomes
Primary Outcomes
Patient and family centeredness of care
Time Frame: 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.
Secondary Outcomes
- 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)