Palliative Care for Heart Failure or Cancer

(TIER-PC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Laura P Gelfman, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Cancer and heart failure, Lung cancer mutation, Supportive oncology/cardiology visits, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines. In Tier 1, patients who are able to care for themselves and no/mild symptoms receive a community health worker (CHW) trained to elicit illness understanding in a culturally competent way. In Tier 2, for patients with poorer function and mild symptoms, a social worker (SW), trained in serious illness communication, joins the CHW to further elicit patients' goals and prognostic understanding while communicating symptom needs to their primary clinician. In Tier 3, as function decreases and symptoms increase, an advance practice nurse (APN) joins the CHW and SW to manage complex symptoms. Finally, in Tier 4, for those older adults with the poorest function and most complex symptoms, a physician joins the team to ensure that the most complex needs (e.g., end-of-life treatment preferences and multifaceted symptom control) are met. The CHW follows patients longitudinally across all tiers and re-allocates them to the appropriate tier based on their evolving needs.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Tier - Palliative Care, TIER-PC, Palliative Care at Home (PC@H) for heart failure or cancer?

Research shows that palliative care can improve treatment outcomes for patients with heart failure and advanced cancer, enhancing their quality of life and managing symptoms effectively. ^{1 2 3 4 5}

Is palliative care safe for people with heart failure or cancer?

The research does not specifically address safety concerns, but palliative care is generally aimed at improving quality of life and managing symptoms for people with serious illnesses like heart failure and cancer. ^{1 2 3 6 7}

How is palliative care unique for heart failure or cancer?

Palliative care for heart failure or cancer is unique because it focuses on improving quality of life and relieving symptoms rather than curing the disease. It is holistic, meaning it considers the whole person, including their physical, emotional, and social needs, and is often underutilized in heart failure patients despite its benefits. ^{1 2 3 6 8}

Research Team

Laura P Gelfman, MD, MPH

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults with advanced heart failure or cancer (intestinal, gastrointestinal, stomach, lung) who need different levels of palliative care. The care level adjusts as symptoms and personal care abilities change. Patients must be able to receive home-based care.

Inclusion Criteria

I am older than 18 years.

I understand and can agree to the study's procedures and risks.

I am fluent in English or Spanish.

Exclusion Criteria

Callahan 6-Item Cognitive Screening score ≤3

I have been diagnosed with both cancer and advanced heart failure.

I visited a cancer or heart support doctor less than 3 months ago.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 months

Active Enrollment

Participants are enrolled and receive either usual care or the TIER-PC intervention

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after the active enrollment period

3 months

Data Analysis

Data analysis is conducted to evaluate the efficacy of the TIER-PC intervention

3 months

Treatment Details

Interventions

• Tier - Palliative Care (Behavioral Intervention)

Trial Overview The TIER-PC model is being tested to provide adaptive palliative care at home. It adds more healthcare professionals to the patient's team as their condition worsens, ranging from a community health worker to a physician in the most severe cases.

Participant Groups

Group I: Tier - Palliative Care Experimental Treatment 1 Intervention

Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.

Group II: Usual care Active Control 1 Intervention

Patients will be cared for by the physician who treats their serious illness (cardiologist, oncologist, primary treating clinician) and other illnesses.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

Findings from Research

Patients with heart failure (HF) are referred to palliative care (PC) later in their hospital stay compared to cancer patients, with an average delay of 4.6 days before consultation, which may limit the benefits of symptom management.

Despite being less likely to be referred for non-pain symptoms, patients with HF reported significant improvements in dyspnea after PC consultation, indicating that early involvement of PC could enhance symptom relief and overall care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Hospitalized Patients With Heart Failure and Cancer Referred to Palliative Care. Liu, AY., O'Riordan, DL., Marks, AK., et al.[2020]

Palliative care (PC) significantly reduces hospital admissions for heart failure (HF) patients, with a notable odds ratio of 0.67, indicating its effectiveness in this group compared to other noncancer chronic illnesses where no significant reduction was observed.

Both HF and non-HF patients experienced increased advance care planning due to PC, with odds ratios of 4.29 and 2.67 respectively, highlighting the importance of PC in facilitating discussions about future care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Palliative Care Intervention With Health Care Use, Symptom Burden and Advance Care Planning in Adults With Heart Failure and Other Noncancer Chronic Illness. Maqsood, MH., Khan, MS., Warraich, HJ.[2021]

In a study of 705 patients with stage IV cancer, 47% were referred to palliative care (PC), with nearly half of those referrals occurring early (within 60 days of diagnosis), highlighting the importance of timely access to supportive care.

Patients referred to PC were more likely to receive hospice care (79%) compared to those not referred (55%), indicating that early palliative care can enhance end-of-life support and improve overall patient and family experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How, when, and why individuals with stage IV cancer seen in an outpatient setting are referred to palliative care: a mixed methods study. Dillon, EC., Meehan, A., Li, J., et al.[2021]

The study involved interviews with 14 Iranian nurses to explore their experiences and perceptions of palliative care outcomes for cancer patients, revealing that palliative nursing is viewed as an abstract concept.

Two main themes emerged: 'providing excellent palliative care,' which emphasizes the importance of a humanistic approach and unique nursing qualities, and 'palliative care as an alarm,' highlighting the challenges and concerns nurses face in delivering care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Nursing for Cancer Patients as an Abstract Concept: A Hermeneutic Study. Borimnejad, L., Mardani-Hamooleh, M., Seyedfatemi, N., et al.[2018]

The home-based palliative heart failure (HPHF) program significantly improved the quality of life (QOL) for patients with end-stage heart failure (ESHF), as evidenced by higher McGill QOL scores compared to the control group after 12 weeks.

Patients in the HPHF program reported greater satisfaction with their care and experienced lower caregiver burden, highlighting the program's effectiveness in supporting both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Home-Based Palliative Heart Failure Program on Quality of Life, Symptom Burden, Satisfaction and Caregiver Burden: A Randomized Controlled Trial. Ng, AYM., Wong, FKY.[2018]

Out of 536 patients with advanced cancer, 45% were referred to palliative care (PC), with significant differences in access based on cancer type, particularly higher access for breast and gynecological cancers.

Patients referred to PC received less aggressive treatments, such as chemotherapy and intensive care, in their final weeks of life, indicating that PC may lead to a more comfortable end-of-life experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. Ledoux, M., Rhondali, W., Lafumas, V., et al.[2019]

Palliative care (PC) significantly improves outcomes for heart failure (HF) patients and their caregivers, enhancing aspects like dyspnea, sleep, and emotional wellbeing, while also reducing the need for medical services.

Despite its benefits, PC is underutilized among HF patients, especially in resource-limited countries, highlighting the need for early integration of PC into HF management and better training for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Care in Heart Failure: A Public Health Emergency. Mosoiu, D., Rogozea, L., Landon, A., et al.[2021]

References

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

A Comparison of Hospitalized Patients With Heart Failure and Cancer Referred to Palliative Care. [2020]

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

Association of Palliative Care Intervention With Health Care Use, Symptom Burden and Advance Care Planning in Adults With Heart Failure and Other Noncancer Chronic Illness. [2021]

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

Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

How, when, and why individuals with stage IV cancer seen in an outpatient setting are referred to palliative care: a mixed methods study. [2021]

5. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Palliative Nursing for Cancer Patients as an Abstract Concept: A Hermeneutic Study. [2018]

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

Effects of a Home-Based Palliative Heart Failure Program on Quality of Life, Symptom Burden, Satisfaction and Caregiver Burden: A Randomized Controlled Trial. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. [2019]

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

Palliative Care in Heart Failure: A Public Health Emergency. [2021]