Palliative Care Models for Critical Condition

No longer recruiting at 1 trial location

Overseen By Dorothy Sheu, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Death, Active discharge order

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

Compensation: Varies

Number of Visits: Unknown

Duration: 36 to 170 hours post admission

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different models of palliative care can improve the quality of life for people with serious illnesses. It examines three approaches: standard care, generalist palliative care (where regular doctors receive additional training), and specialist palliative care (involving palliative care experts). The goal is to determine which approach is most feasible and effective in reducing suffering and improving care processes for patients at significant risk of dying within a year. This trial is best suited for hospitalized patients facing a serious illness with a high chance of not surviving beyond a year. As an unphased trial, it offers patients the opportunity to contribute to valuable research that could enhance palliative care practices for those with serious illnesses.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Previous studies have shown that palliative care (PC) reduces suffering and improves the quality of life for people with serious illnesses. Research indicates that both generalist and specialist palliative care are generally well-tolerated by patients.

For generalist palliative care, research has not reported any significant negative effects. When regular doctors receive training in palliative care skills, it is considered safe for patients.

Specialist palliative care, involving consultations with experts, is also considered safe. Studies show that these expert consultations do not cause harm. Instead, they increase the number of consultations and help patients receive care more quickly.

Overall, palliative care, whether provided by generalists or specialists, is not linked to negative side effects and is considered safe for patients who need it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these palliative care models because they offer innovative approaches to managing care for patients with critical conditions. The "Accountable Justification" model empowers trained generalist clinicians to actively document palliative care decisions, encouraging more thoughtful and personalized care for moderately high-risk patients. The "Default Order" model automatically initiates specialist palliative care consultations for high-risk patients, potentially leading to quicker access to specialized support. Unlike traditional models where palliative care might only be introduced late in the treatment process, these approaches aim to integrate it more seamlessly, potentially improving patient outcomes and satisfaction.

What evidence suggests that this trial's treatments could be effective for improving quality of life in seriously ill patients?

Research has shown that palliative care can greatly enhance the quality of life for patients with serious illnesses. In this trial, participants will be assigned to different palliative care models. One arm involves Trained Generalist Palliative Care, where regular doctors trained in basic palliative skills work to improve care and reduce costs. Another arm involves Specialist Palliative Care, which includes experts and has increased the number of consultations and improved patient satisfaction. Both methods aim to ease suffering and support patients and their families during difficult times. Additionally, a Standardized Usual Care arm serves as an active control group. ^{1 2 5 6 7}

Who Is on the Research Team?

Katherine Courtright, MD, MS

Principal Investigator

University of Pennsylvania

Scott D Halpern, MD PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for seriously ill hospitalized patients aged 18 or older, admitted to one of the study hospitals with a predicted mortality risk of at least 60% within the next year. It aims to improve their quality of life through palliative care.

Inclusion Criteria

I am admitted to a hospital participating in the study.

My doctor says I have a high risk (60% or more) of not surviving the next year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

36 hours post admission

Treatment

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

36 to 170 hours post admission

Follow-up

Participants are monitored for process outcomes and completion of patient-reported outcome surveys

3 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Accountable Justification
• Default Order
• Standardized Usual Care

Trial Overview The study compares three approaches: usual care without specific PC training, generalist PC where hospital staff are trained online in palliative care, and specialist PC provided by experts. The goal is to see which model works best for patient support.

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 moderately high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the highest-risk patients 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 ≥ 60% 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 moderately high-risk patients (e.g., with a 1-year mortality risk between 60% and 94%) will receive usual care. A specialist PC consult is ordered by default for the highest-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+

Published Research Related to This Trial

Health care spending is expected to reach 19.6% of GDP by 2021, prompting the need for innovative care models to improve value, particularly through Accountable Care Organizations (ACOs) that assume financial risk for patient outcomes.

Palliative care can enhance the quality of care and reduce costs for high-risk patients within ACOs by implementing targeted interventions and population management strategies, thus playing a crucial role in optimizing patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of palliative care in population management and accountable care organizations. Smith, G., Bernacki, R., Block, SD.[2018]

Two main models for integrating palliative care in intensive care units (ICUs) were identified: the consultative model, which enhances the role of palliative care consultants for high-risk patients, and the integrative model, which incorporates palliative care principles into the daily practices of the ICU team for all patients.

Implementing a structured palliative care initiative in ICUs can significantly improve the quality of care for critically ill patients and their families, emphasizing the importance of assessing resources and stakeholder attitudes before choosing a model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models for structuring a clinical initiative to enhance palliative care in the intensive care unit: a report from the IPAL-ICU Project (Improving Palliative Care in the ICU). Nelson, JE., Bassett, R., Boss, RD., et al.[2022]

Participants in the study showed varying levels of knowledge about palliative care (PC), particularly regarding available services, payment methods, and how to initiate care, indicating a need for better education on these topics.

While some participants appreciated the increased support and time provided by clinicians in the new community-based PC model, there were concerns about the model's implementation within the current healthcare system and the perception of PC providers as consultants rather than full-time caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient, Caregiver, and Taxpayer Knowledge of Palliative Care and Views on a Model of Community-Based Palliative Care. Boucher, NA., Bull, JH., Cross, SH., et al.[2019]

Specialist palliative care (PC) can provide significant clinical benefits to patients while also aligning financial incentives for hospitals and payers, suggesting a need for a new business model that supports community-based PC.

Key developments supporting this model include penalties for excessive hospital stays, alternative payment models like accountable care organizations, and partnerships between payers and providers that enhance access to community-based PC services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Business Case for Palliative Care: Translating Research Into Program Development in the U.S. Cassel, JB., Kerr, KM., Kalman, NS., et al.[2018]

The study introduces an Interdisciplinary Palliative Care Services Agreement aimed at establishing a financially sustainable model for palliative care in a large academic medical center, emphasizing the importance of value in medical care for patients in need of palliative services.

Quality standards are central to this framework, guiding team interventions and serving as metrics for financial support, which helps position palliative medicine competitively with other medical specialties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model to improve value: the interdisciplinary palliative care services agreement. Porter-Williamson, K., Parker, M., Babbott, S., et al.[2009]

The REDAPS study is a large-scale trial involving 12,000 to 15,000 patients aged 65 and older across 11 hospitals, aiming to evaluate the effectiveness and cost-efficiency of default access to palliative care services for patients with serious illnesses.

The study hypothesizes that changing the default option for palliative care consultations from opt-in to opt-out can improve patient-centered outcomes, such as in-hospital mortality and length of stay, without increasing costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) Trial. Courtright, KR., Madden, V., Gabler, NB., et al.[2022]

In a study of 402 patients with late-stage illnesses, discussions about goals of care were linked to higher rates of in-hospital death and hospice referrals, highlighting their importance in end-of-life planning.

Consultation with specialty palliative care significantly reduced the likelihood of in-hospital death and increased hospice referrals, suggesting that specialized palliative care can improve end-of-life outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Receipt of Recommended Elements of Palliative Care Precede In-Hospital Death or Hospice Referral? Ernecoff, NC., Wessell, KL., Hanson, LC., et al.[2021]

In Australia, over 85% of patients referred to specialized hospice/palliative care services have cancer, highlighting the importance of these services in cancer care, with data collected from 5,395 patients across 6,379 admissions.

The Palliative Care Outcomes Collaboration (PCOC) revealed significant variations in patient outcomes, such as stability after an unstable phase (12-fold differences) and improvements in symptom scores (seven-fold differences), indicating the need for ongoing data collection and benchmarking in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it feasible and desirable to collect voluntarily quality and outcome data nationally in palliative oncology care? Currow, DC., Eagar, K., Aoun, S., et al.[2008]

In a study of 43,067 cancer patients in the Netherlands, those who received palliative care (PC) more than 30 days before death were significantly less likely to experience potentially inappropriate end-of-life care (16% vs 45%).

Timely access to palliative care, whether initiated early (more than 90 days before death) or late (between 30 and 90 days), greatly reduced the odds of inappropriate care, highlighting the importance of generalist PC in improving end-of-life experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inappropriate end-of-life cancer care in a generalist and specialist palliative care model: a nationwide retrospective population-based observational study. Boddaert, MS., Pereira, C., Adema, J., et al.[2023]

A consensus process led to the development of 18 preliminary quality measures for assessing palliative care in critically ill patients, focusing on both process and structural aspects of care.

The majority of these measures (14) evaluate the processes of care at the patient level, highlighting the need for future research to link these measures to health outcomes and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposed quality measures for palliative care in the critically ill: a consensus from the Robert Wood Johnson Foundation Critical Care Workgroup. Mularski, RA., Curtis, JR., Billings, JA., et al.[2020]

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2813879

Default Palliative Care Consultation for Seriously Ill ... Default orders significantly increased consultation rate compared with usual care (43.9% vs 16.6%), decreased time to consultation by 1.2 days, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38227032/

Default Palliative Care Consultation for Seriously Ill ... - PubMed Default palliative care consult orders did not reduce length of stay for older, hospitalized patients with advanced chronic illnesses, but did improve the rate ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07224594

Comparing Optimized Models of Primary And Specialist ... Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families.

4. files-profile.medicine.yale.edu files-profile.medicine.yale.edu/documents/80d53a09-17f0-42a6-96ad-443f3dc616e0

Default Palliative Care Consultation for Seriously Ill ... Outcome data collection ended on January 31, 2019. INTERVENTION Ordering palliative care consultation by default for eligible patients, while.

5. withpower.com withpower.com/trial/phase-seriously-ill-hospitalized-patients-9-2024-1be4c

Palliative Care Models for Critical Condition What data supports the effectiveness of the treatment Accountable Justification, Default Order, Standardized Usual Care, Standard Care, Usual Medical Care ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10792472/

Palliative Care Consultation for Seriously Ill Hospitalized ... Default orders significantly increased consultation rate compared with usual care (43.9% vs 16.6%), decreased time to consultation by 1.2 days, and increased ...

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

What gets measured in palliative care? A review and ... The JSPM registry includes outcomes such as: discharge status (i.e., discharged from service; discharged to palliative care units; discharged to other ...