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}

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mount Sinai Hospital New York, NY

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai Lead Sponsor

National Institute of Nursing Research (NINR) Collaborator

References

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

A Comparison of Hospitalized Patients With Heart Failure and Cancer Referred to Palliative Care. [2020] Growing evidence shows that palliative care (PC) improves treatment outcomes in patients with heart failure (HF), but few large-scale studies have prospectively evaluated the processes and outcomes associated with PC consultation for such patients in the real world.

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] Palliative care (PC) improves outcomes in noncancer illness. We hypothesized the benefit is driven by studies of heart failure (HF) patients exclusively versus studies of other noncancer illnesses.

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

Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience. [2023] Palliative care (PC) in advanced heart failure (HF) aims to improve symptoms and quality of life (QOL), in part through medication management. The impact of PC on polypharmacy (>5 medications) remains unknown.

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] Early palliative care (PC) for individuals with advanced cancer improves patient and family outcomes and experience. However, it is unknown when, why, and how in an outpatient setting individuals with stage IV cancer are referred to PC.

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

Palliative Nursing for Cancer Patients as an Abstract Concept: A Hermeneutic Study. [2018] Understanding the outcomes of palliative care (PC) that is provided to patients with cancer is necessary.

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] Provision of home-based palliative care (PC) for seriously ill patients is important, yet few home-based PC services specifically or exclusively focus on end-stage heart failure (ESHF) patients.

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] Palliative care (PC) improves the quality of life of patients with advanced cancer. Our aim was to describe PC referral among patients with advanced cancer, and associated outcomes in an academic medical centre.

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

Palliative Care in Heart Failure: A Public Health Emergency. [2021] Palliative care (PC) is the holistic care of patients with life-limiting illnesses focused on relief of suffering and maximizing quality of life for patients and their families. Patients with heart failure (HF) are the largest group eligible for PC services, but only a small percentage of them receive PC.