Palliative Care for Critical Condition

(COMPASS-PC Trial)

Not yet recruiting at 1 trial location

Overseen By Vanessa Madden, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Hospice, Psychiatry, Obstetrics, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving the quality of life for patients with serious illnesses by testing various palliative care approaches. Palliative care seeks to ease suffering and support patients and their families. Participants will receive either standard care, care from trained generalist doctors, or care from specialist doctors. The trial seeks seriously ill patients who have been informed of a high chance of not surviving the next year. As an unphased trial, it offers patients the opportunity to contribute to valuable research that could enhance palliative care practices.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that palliative care, which reduces suffering and improves the quality of life for seriously ill patients, is generally well-received. Many studies have found that patients receiving specialized palliative care consultations often experience better quality of life and more support during hospital stays.

The "default order" approach led to more patients receiving timely palliative care compared to usual care. This method did not increase the risk of death, indicating its safety. Additionally, patients were often discharged to hospice care, which offers more focused support.

Generalist palliative care, where regular doctors receive extra training, also appears safe. These doctors use electronic alerts to help decide when to address palliative issues, ensuring patients receive necessary care without significant safety concerns.

Overall, both specialist and generalist palliative care are considered safe for patients. Both approaches aim to improve quality of life without adding any known serious risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these trial methods because they aim to improve how palliative care is delivered to high-risk patients. Unlike standard care, which often involves reactive measures, these methods use "accountable justification" and "default order" interventions that prompt healthcare providers to proactively consider palliative care for patients with significant mortality risk. For example, the "Trained Generalist Palliative Care" approach alerts general clinicians to address key palliative care areas, ensuring no important aspect is overlooked. Meanwhile, the "Specialist Palliative Care" intervention automatically arranges specialist consultations for those most at risk, which could enhance the timeliness and effectiveness of care. Overall, these strategies could lead to more consistent and early integration of palliative care, potentially improving patient outcomes and satisfaction.

What evidence suggests that this trial's treatments could be effective for palliative care?

This trial compares different approaches to palliative care for patients with critical conditions. Studies have shown that palliative care can greatly improve the quality of life for patients with serious illnesses. One arm of the trial involves Specialist Palliative Care, where experts provide care that effectively reduces symptoms and improves patient outcomes. Research has shown that using standard procedures to arrange palliative care consultations increases the number of consultations, leading to better support for patients. Another arm involves Trained Generalist Palliative Care, where regular doctors and nurses receive training to provide basic palliative care, improving patient experiences by better meeting their needs. Overall, both trained generalists and specialists in palliative care significantly enhance patient care. The trial also includes a Standardized Usual Care arm as an active control group. ^{1 6 7 8 9}

Who Is on the Research Team?

Scott Halpern, MD, PhD

Principal Investigator

University of Pennsylvania

Katherine Courtright, MD, MS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for seriously ill hospitalized patients with a high risk (at least 70%) of dying within the next year. It's taking place in 48 hospitals across two large U.S. health systems, and involves more than 78,000 participants who are assessed shortly after admission.

Inclusion Criteria

Age 18 years of age or older

Predicted 1-year mortality risk of 70% or greater

Admitted to a study hospital

Exclusion Criteria

Ineligible service line, with current admission status labeled as: hospice, acute rehabilitation, skilled nursing facility, long-term acute care, psychiatry, obstetrics

Patients who die or have an active or completed discharge order prior to enrollment time

Readmission within 182 days of an eligible encounter

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

1 visit (in-person)

Enrollment Assessment

Enrollment assessment occurs as close as possible to 36 hours post admission

1-2 days

1 visit (in-person)

Treatment

Participants receive either standardized usual care, trained generalist palliative care, or specialist palliative care

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Accountable Justification
• Default Order
• Standardized Usual Care

Trial Overview The study compares three approaches to palliative care: usual care without specific training, generalist palliative care provided by clinicians trained online through CAPC, and specialist palliative care. Hospitals are randomly assigned to one of these methods to see which is most effective at improving patient outcomes.

How Is the Trial Designed?

Group I: Trained Generalist Palliative Care Experimental Treatment 2 Interventions

Generalist clinicians trained in PC domains receive an EHR-based alert to document whether or not they have addressed PC domains for high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the very high risk patients (i.e., 1-year mortality risk ≥ 95%) unless clinicians cancel the order.

Group II: Specialist Palliative Care Experimental Treatment 1 Intervention

A specialist PC consult is ordered by default for all patients with a ≥ 70% 1-year mortality risk ('default order intervention'), unless clinicians cancel the order.

Group III: Standardized Usual Care Active Control 1 Intervention

Active control group, where high-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. A specialist PC consult is ordered by default for the very high-risk patients (i.e., 1-year mortality risk ≥ 95%), unless clinicians cancel the order.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Duke Clinical Research Institute

Collaborator

Trials

69

Recruited

242,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07224594

Comparing Optimized Models of Primary And Specialist ... This pragmatic, hybrid effectiveness-implementation parallel-cluster RCT will assess the comparative effectiveness of triggering generalist PC ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11846008/

Algorithm-Based Palliative Care in Patients With Cancer Do default specialty palliative care orders with opting out and accountable justification increase consultation and improve outcomes in patients

3. pcori.org pcori.org/research-results/2023/comparing-palliative-care-delivered-generalist-clinicians-versus-palliative-care-specialists-patients-hospitalized-advanced-illnesses

Comparing Palliative Care Delivered by Generalist ... This study compares the clinical effectiveness of palliative care delivered by generalist clinicians trained in basic palliative care skills ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07224594?rank=3

Comparing Optimized Models of Primary And Specialist ... This pragmatic, hybrid effectiveness-implementation parallel-cluster RCT will assess the comparative effectiveness of triggering generalist PC ...

5. liebertpub.com liebertpub.com/doi/10.1089/jpm.2022.0461

Systematic Review of Models of Effective Community ... Community specialist palliative care was found to improve symptom burden/quality of life and to reduce secondary service utilization across cancer and noncancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8020719/

Prognosticating Outcomes and Nudging Decisions with ... The primary outcome is hospital length of stay. Secondary outcomes include other clinical outcomes, palliative care process measures, and nurse-assessed quality ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2590229625000061

What gets measured in palliative care? A review and ... We conducted an extensive review of policy documents to identify international best practice in the use of routine data in palliative care.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4519048/

The Role of Palliative Care in Population Management and ... Multiple randomized-controlled trials of specialist palliative care team interventions have shown improved outcomes, including improved quality of life, greater ...

9. spcare.bmj.com spcare.bmj.com/content/12/e3/e403

Patient safety incidents in advance care planning for ... This study characterises and explores patient safety incidents arising from ACP processes in the last phase of life.