Improving care for older adults in the ICU with palliative support
Randomized Trial of Specialty Palliative Care Integrated With Critical Care for Critically Ill Older Adults
This study is testing if adding palliative care early in the treatment of older adults in the ICU can improve their health and help families cope better during tough times.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04921631 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the care provided to critically ill older adults by integrating specialty palliative care early in their treatment within the ICU. The study will involve 500 patients, 750 family surrogates, and up to 150 clinicians to assess whether this approach can improve patient outcomes and reduce psychological distress for families. Participants will be selected based on specific acute or chronic health conditions that indicate a high risk of death or severe functional impairment. The trial seeks to address the urgent need for better communication and decision-making support in critical care settings.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults aged 60 and above who are admitted to the ICU with specific acute or chronic health conditions.
Not a fit: Patients who are younger than 60 or do not meet the specified health criteria for palliative care consultation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved quality of life and reduced suffering for critically ill older patients and their families.
How similar studies have performed: Other studies have shown promising results with early integration of palliative care in critical settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Douglas B White, MD, MAS — University of Pittsburgh
- Study coordinator: Douglas B White, MD, MAS
- Email: douglas.white@pitt.edu
- Phone: 412-864-3757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.