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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 3 months

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,340,446 Total Patients Enrolled

13 Trials studying Critical Illness

5,370 Patients Enrolled for Critical Illness

Massachusetts General HospitalOTHER

2,933 Previous Clinical Trials

13,195,981 Total Patients Enrolled

12 Trials studying Critical Illness

2,822 Patients Enrolled for Critical Illness

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,018,425 Total Patients Enrolled

14 Trials studying Critical Illness

3,894 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots available for participants in this research trial?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this medical experiment is still enrolling participants. It was first announced on June 28th 2021 and has been renewed subsequently until August 2nd 2022. 500 candidates are intended to be recruited from one site."

Answered by AI

How many participants are involved in this clinical investigation?

"Affirmative. Evidenced by clinicaltrials.gov, this trial is actively searching for participants after being initially posted on June 28th of 2021 and most recently updated on August 2nd 2022. It requires 500 volunteers from one site to partake in the study."

Answered by AI

Recent research and studies

Journal of Pain and Symptom ManagementJournal

Validation of Toolkit After-death Bereaved Family Member Interview

Teno, Joan M, Brian Clarridge, Virginia Casey, Susan Edgman-Levitan, and Jack Fowler. 2001. “Validation of Toolkit After-death Bereaved Family Member Interview”. Journal of Pain and Symptom Management. Elsevier BV. doi:10.1016/s0885-3924(01)00331-1.

JAMA Network OpenJournal

Concordance of End-of-life Care with End-of-life Wishes in an Integrated Health Care System

Glass, David P., Susan E. Wang, Paul M. Minardi, and Michael H. Kanter. 2021. “Concordance of End-of-life Care with End-of-life Wishes in an Integrated Health Care System”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2021.3053.

Journal of Pain and Symptom ManagementJournal

Propacc: Protocol for a Trial of Integrated Specialty Palliative Care for Critically Ill Older Adults

Andersen, Sarah K., Grace Vincent, Rachel A. Butler, Elke H.P. Brown, Dave Maloney, Sana Khalid, Rae Oanesa, et al.. 2022. “Propacc: Protocol for a Trial of Integrated Specialty Palliative Care for Critically Ill Older Adults”. Journal of Pain and Symptom Management. Elsevier BV. doi:10.1016/j.jpainsymman.2022.02.344.

clinicaltrials.govStudy