Integrated Supportive and Palliative Care for Critical Illness

(ProPACC Trial)

Overseen By Rachel A Butler, MHA, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: No surrogate, Imminently dying, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Index hospitalization

1400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Early Integration of Specialty Palliative Care with Critical Care?

Research shows that integrating palliative care into intensive care units can help reduce stress for patients and families and improve end-of-life care. Additionally, early integration of palliative care in cancer treatment has been found to improve symptom control, quality of life, and even survival, suggesting potential benefits in critical care settings as well. ^{1 2 3 4 5}

Is integrated supportive and palliative care safe for humans?

The integration of palliative care, especially in critical and intensive care settings, is generally considered safe and beneficial for patients, as it focuses on comfort, symptom management, and emotional support. ^{1 2 5 6 7}

How is the treatment 'Early Integration of Specialty Palliative Care with Critical Care' different from other treatments for critical illness?

This treatment is unique because it combines critical care, which focuses on extending life, with palliative care, which emphasizes comfort and quality of life. By integrating these two approaches early, it aims to improve the overall care experience for critically ill patients and their families, addressing both medical and emotional needs. ^{2 3 5 7 8}

Research Team

Douglas B White, MD, MAS

Principal Investigator

University of Pittsburgh

Yael Schenker, MD, MAS

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

I have had a severe health event recently or my doctor thinks I have a high risk of dying or severe long-term problems.

I am 60 years old or older.

I have a serious long-term health condition or am over 80 with multiple major health issues.

Exclusion Criteria

I make my own health decisions.

Determined to be imminently dying (within hours) by CCM physician

Non-English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Early integration of specialty palliative care with standard critical care for critically ill older patients

Index hospitalization

Continuous care during ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3-month and 6-month telephone follow-ups

Long-term follow-up

Assessment of resource utilization and survival from hospital discharge through 6-month follow-up

6 months

Treatment Details

Interventions

• Early Integration of Specialty Palliative Care with Critical Care

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: No intervention Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

In a study of 3,535 patients with advanced cancer, only 18.9% were referred to specialist palliative care, highlighting a significant gap in early intervention.

More than half of the patients who were referred to palliative care did so late, with 30.8% experiencing delays of 8 weeks or more, indicating a need for better practices among general practitioners to integrate palliative care sooner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early integration of palliative care for outpatients with advanced cancer in general practice: how is the situation?-a cohort study. Engeser, P., Glassman, J., Leutgeb, R., et al.[2021]

Integrating palliative care into the intensive care unit (ICU) helps provide comfort and support for patients and their families during the difficult process of end-of-life care, reducing emotional and psychological stress.

The paper discusses quality measures and case studies that demonstrate the benefits of this integration, highlighting its importance in improving the overall experience for patients and families facing terminal illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care in the intensive care unit. Restau, J., Green, P.[2014]

Critical care and palliative care, while seemingly opposite, both focus on the most critically ill patients, with critical care aiming to extend life and palliative care prioritizing comfort and quality of life.

Recent advancements have shown that integrating palliative care into intensive care units is feasible and accepted, paving the way for improved patient care in critical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving palliative care in intensive care units: identifying strategies and interventions that work. Byock, I.[2006]

A systematic review of 58 studies, mostly from North America, found that integrating palliative care into ICUs can improve outcomes such as length of stay and decisions about life-sustaining treatments.

The most common palliative care interventions included communication, ethics consultations, and involvement of palliative care teams, suggesting that enhancing palliative care can benefit both patients and families in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care interventions in intensive care unit patients. Metaxa, V., Anagnostou, D., Vlachos, S., et al.[2022]

A survey of 449 medical oncologists revealed that 86% support early integration of palliative care in oncology, recognizing its importance for improving patient quality of life and potentially survival.

There is a strong consensus (90%) among oncologists that specific training in palliative care should be included in their core curriculum, highlighting a need for better education in symptom management and palliative practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Integration of Palliative Care in Oncology Practice: Results of the Italian Association of Medical Oncology (AIOM) Survey. Zagonel, V., Torta, R., Franciosi, V., et al.[2020]

Early integration of specialist palliative care in adult cancer patients significantly improves health-related quality of life, mood, treatment decision-making, and patient satisfaction, based on a review of 31 studies.

There is moderate evidence that early palliative care can enhance symptom control and even improve survival rates, although these benefits were not observed in inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of Early Specialist Palliative Care in Cancer Care and Patient Related Outcomes: A Critical Review of Evidence. Salins, N., Ramanjulu, R., Patra, L., et al.[2022]

Patients with advanced cancer often face challenges in ICU settings, with many dying in hospitals after life-sustaining treatments are withdrawn, highlighting the need for effective palliative care integration in critical care.

Intensivists are expected to provide basic palliative care, including communication about treatment goals, but inadequate reimbursement for these services may hinder the delivery of high-quality care, emphasizing the importance of proper documentation for billing purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician reimbursement for critical care services integrating palliative care for patients who are critically ill. Lustbader, DR., Nelson, JE., Weissman, DE., et al.[2021]

The Palliative Care Partnership model, which integrates palliative care coordinators with general practitioners and specialist clinicians, has been positively evaluated by stakeholders, indicating its effectiveness in delivering quality palliative care.

Training for general practitioners and practice nurses has led to increased clinical confidence and satisfaction, demonstrating that this model not only improves patient care but also enhances the experience of healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Palliative Care Partnership: a New Zealand solution to the provision of integrated palliative care. McKinlay, E., McBain, L.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

Early integration of palliative care for outpatients with advanced cancer in general practice: how is the situation?-a cohort study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Palliative care in the intensive care unit. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Improving palliative care in intensive care units: identifying strategies and interventions that work. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Palliative care interventions in intensive care unit patients. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Early Integration of Palliative Care in Oncology Practice: Results of the Italian Association of Medical Oncology (AIOM) Survey. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Integration of Early Specialist Palliative Care in Cancer Care and Patient Related Outcomes: A Critical Review of Evidence. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Physician reimbursement for critical care services integrating palliative care for patients who are critically ill. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of the Palliative Care Partnership: a New Zealand solution to the provision of integrated palliative care. [2022]