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Integrated Supportive and Palliative Care for Critical Illness (ProPACC Trial)

N/A
Recruiting
Led By Douglas B White, MD, MAS
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 60 years
Chronic triggers include 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), Pittsburgh Cardiac Arrest Category (PCAC) greater than or equal to 2, organ support: RRT, invasive or non-invasive mechanical ventilation, vasopressors, Sequential Organ Failure Assessment (SOFA) score greater than or equal to 10, Model for End-Stage Liver Disease (MELD) greater than or equal to 30, major comorbidities defined by Charlson Co-morbidity Index (CCI), Clinical Frailty Scale (CFS) score greater than or equal to 6
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 3 months and 6 months
Awards & highlights

ProPACC Trial Summary

This trial will determine whether early integration of specialty palliative care can improve outcomes for critically ill older patients and their families.

Who is the study for?
This trial is for older adults (60+) in the ICU with critical illnesses like coma after cardiac arrest, severe strokes, organ failures, or chronic conditions such as end-stage liver disease. They must have a high risk of death or severe disability and not be imminently dying, within a year post-organ transplant, non-English speaking, or without a surrogate decision maker.Check my eligibility
What is being tested?
The study tests if combining specialty palliative care early on with standard critical care improves outcomes for critically ill older patients at high risk of death/severe impairment and their families. It involves 500 patients/surrogates and up to 1250 clinicians in a randomized trial.See study design
What are the potential side effects?
Since this trial focuses on supportive care rather than medication, side effects are not typical as seen with drugs. However, emotional distress may arise from discussing prognosis and end-of-life preferences.

ProPACC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I have a serious long-term health condition or am over 80 with multiple major health issues.

ProPACC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient and family centeredness of care
Secondary outcome measures
Composite measure of goal-concordant care
Cost of index hospitalization
Mechanical ventilation
+11 more
Other outcome measures
Days alive outside healthcare facilities
Duration of survival from hospital discharge through 6-month follow-up
Patient hospital survival
+1 more

ProPACC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The intervention arm will receive early specialty palliative care integrated with standard critical care.
Group II: No interventionActive Control1 Intervention
Usual ICU care; each study ICU has a policy for family meetings within 72 hours of admission and at least weekly thereafter.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,731 Previous Clinical Trials
16,304,648 Total Patients Enrolled
13 Trials studying Critical Illness
5,370 Patients Enrolled for Critical Illness
Massachusetts General HospitalOTHER
2,945 Previous Clinical Trials
13,201,378 Total Patients Enrolled
12 Trials studying Critical Illness
2,822 Patients Enrolled for Critical Illness
National Institute on Aging (NIA)NIH
1,694 Previous Clinical Trials
28,024,825 Total Patients Enrolled
15 Trials studying Critical Illness
3,994 Patients Enrolled for Critical Illness

Media Library

Early Integration of Specialty Palliative Care with Critical Care Clinical Trial Eligibility Overview. Trial Name: NCT04921631 — N/A
Critical Illness Research Study Groups: Intervention, No intervention
Critical Illness Clinical Trial 2023: Early Integration of Specialty Palliative Care with Critical Care Highlights & Side Effects. Trial Name: NCT04921631 — N/A
Early Integration of Specialty Palliative Care with Critical Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04921631 — N/A
~864 spots leftby Feb 2026
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