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.
Is palliative care a promising treatment for heart failure or cancer?Yes, palliative care is a promising treatment for heart failure and cancer because it focuses on improving the quality of life for patients and their families by relieving suffering and managing symptoms.24578
What safety data exists for palliative care in heart failure or cancer?The provided research does not directly address safety data for palliative care in heart failure or cancer. However, it suggests that palliative care improves treatment outcomes, quality of life, and symptom management in these conditions. Specific safety data might be found in detailed study results or clinical trial reports not included in the abstracts.12578
What data supports the idea that Palliative Care for Heart Failure or Cancer is an effective treatment?The available research shows that palliative care improves outcomes for patients with heart failure and cancer. For heart failure, studies indicate that palliative care helps manage symptoms and enhances quality of life. In cancer patients, early palliative care improves both patient and family experiences. This suggests that palliative care is effective in providing better overall care compared to not using it.35678
Do I need to stop my current medications to join the trial?The trial protocol 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.
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 have had multiple hospital visits due to heart failure or cancer.
I can care for myself and perform daily activities.
Exclusion Criteria
I have been diagnosed with both cancer and advanced heart failure.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Tier - Palliative CareExperimental Treatment1 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 careActive Control1 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 nearbySelect from list below to view details:
Mount Sinai HospitalNew York, NY
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
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.
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.
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.
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.
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.
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.
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.
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.