Integrated Supportive and Palliative Care for Older Adults in the ICU (ProPACC)

University of Pittsburgh

Status: Enrolling

Conditions: Critical Illness

Treatments: Behavioral: Early Integration of Specialty Palliative Care with Critical Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04921631

R01AG068567-01 (U.S. NIH Grant/Contract)

STUDY20030163

Details and patient eligibility

About

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 1250 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

2,500 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention arm will receive early specialty palliative care integrated with standard critical care.

Treatment:

Behavioral: Early Integration of Specialty Palliative Care with Critical Care

No intervention

No Intervention group

Description:

Usual ICU care; each study ICU has a policy for family meetings within 72 hours of admission and at least weekly thereafter.