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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if integrating palliative care early with standard critical care can improve outcomes for critically ill older patients and reduce stress for their families. Palliative care prioritizes comfort and quality of life rather than solely extending life. The trial includes two groups: one receiving early palliative care alongside usual ICU care, and another receiving only standard ICU care. Suitable participants have recently been in the ICU with serious health issues, such as advanced cancer or severe organ failure, or have shown significant health decline. As an unphased trial, this study provides a unique opportunity to contribute to understanding how early palliative care can enhance patient and family experiences.

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 prior data suggests that this protocol is safe for critically ill older patients?

Research shows that combining palliative care with critical care is generally well-received by patients. Studies have found that this approach reduces discomfort, meaning patients feel less pain and distress. It also improves communication between doctors and patients about treatment goals, ensuring that care aligns with patient preferences.

Evidence from heart intensive care units suggests that early palliative care positively affects patient outcomes. This includes enhancing the effectiveness of ICU care and possibly improving the overall experience for both patients and their families.

In short, studies indicate that early palliative care in critical care is safe and beneficial for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the early integration of specialty palliative care with critical care because it aims to blend compassionate support with intensive medical treatment right from the start of a critical illness. Unlike standard ICU care, which typically involves family meetings after admission, this approach actively involves palliative care specialists early on to address not just physical symptoms but also emotional and psychological needs. This integrated method could potentially improve patient outcomes and family satisfaction, leading to a more holistic and supportive experience during critical illness.

What evidence suggests that early integration of specialty palliative care with critical care is effective for critically ill older patients?

This trial will compare the early integration of specialty palliative care with standard critical care to usual ICU care. Research has shown that starting palliative care early alongside critical care in the ICU can greatly benefit patients. Studies have found that this approach eases symptoms and aligns treatments with patient preferences. It also reduces stress for family members and improves communication about care goals. Palliative care plays a crucial role in managing symptoms and providing emotional support, often needed in intensive care. Overall, combining palliative care with critical care leads to better outcomes for seriously ill patients and their families. ^{1 3 6 7 8}

Who Is on the Research Team?

Douglas B White, MD, MAS

Principal Investigator

University of Pittsburgh

Yael Schenker, MD, MAS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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

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

I make my own health decisions.

Non-English speaking

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5065723/

Integration of Palliative Care in Chronic Critical Illness ... Core elements include alleviation of symptom distress, communication about care goals, alignment of treatment with the patient's values and preferences, ...

2. link.springer.com link.springer.com/article/10.1007/s00134-022-06729-7

Integrating palliative care into the ICU: a lasting and ... It is widely accepted that ICU clinicians need training and expertise in primary palliative care skills including symptom assessment and management.

3. ascopubs.org ascopubs.org/doi/10.1200/EDBK_100038

Why and How to Integrate Early Palliative Care Into Cutting ... Palliative care integrated with oncology care early in the course of illness, has myriad benefits for patients and their caregivers.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9693909/

Rationale for integration of palliative care in the medical ... Palliative care has several beneficial roles in intensive care, such as symptom control, end-of-life discussions, and providing psychological support to ...

5. jpsmjournal.com jpsmjournal.com/article/S0885-3924(22)00479-1/fulltext

Utilization and Delivery of Specialty Palliative Care in the ICU Palliative care (PC) benefits critically ill patients but remains underutilized. Important to developing interventions to overcome barriers to PC in the ICU.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9299559/

ProPACC: Protocol for a Trial of Integrated Specialty Palliative ... This trial will provide robust evidence about the impact of integrating SPC with critical care on patient, family, and health system outcomes. Keywords: ...

7. medstarhealth.org medstarhealth.org/blog/palliative-care-cardiac-icu

Earlier Palliative Care Improves Patient Outcomes in the ... Our study of patients in the cardiac intensive care unit at MedStar Washington Hospital Center finds that palliative care positively impacts ICU care.

8. aacnjournals.org aacnjournals.org/aacnacconline/article/35/2/157/32476/Innovative-Strategies-for-Palliative-Care-in-the

Innovative Strategies for Palliative Care in the Intensive Care ... This article reviews 2 evidence-based practice projects, a serious illness support tool and the 3 Wishes Project, to add to the palliative care toolkit.