Palliative Care Model for People With Advanced Heart Failure or Cancer
Tests a palliative care model that adds team members as symptoms and function change.
Key facts
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Where
- New York, United StatesSee the site
- Trial code
- Registry title
- Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 31 Jan 2025
- Expected to end
- 1 Sept 2030
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Tier-Palliative Care
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in Manhattan with advanced heart failure or advanced lung or non-colorectal gut cancer who have been in hospital recently and can still function fairly well.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced heart failure with two heart-failure hospitalizations in the last 12 months, or advanced lung or non-colorectal gastrointestinal cancer (pancreatic, gastric, hepatobiliary, small bowel, esophageal) with one hospitalization in the last 6 months. Activity level: KPS > 50% (ECOG 0, 1 or 2).
- Earlier treatment
- More than 2 outpatient MSHS visits in the prior 12 months. Cannot have had a ventricular assist device or a heart transplant, or be in hospice care before joining.
- Biomarker or test result
- Lung cancer with a driver mutation (for example EGFR) that gives a favorable outlook is excluded.
Main reasons for not taking part
- Both cancer and advanced heart failure
- Lung cancer with a driver mutation such as EGFR that gives a favorable prognosis
- Living in a facility (subacute rehab, long-term care, hospice)
- Receiving hospice care, or enrolled in another palliative care study
- Callahan 6-Item Cognitive Screening score of 3 or less
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Advanced Heart Failure (HF) with two HF-related hospitalizations within the last 12 months or
- Advanced lung or non-colorectal gastrointestinal cancer (pancreatic, gastric, hepatobiliary, small bowel, esophageal) with one hospitalization within the last 6 months
- KPS > 50% (ECOG 0, 1 or 2)
- > 2 outpatient MSHS visits in prior 12 months
- Manhattan residence
- Capacity to provide informed consent
- English or Spanish fluency
- > 18 years of age
Who cannot take part
- Previous receipt of a ventricular assist device or previous heart transplantation
- Receiving hospice care prior to study enrollment or enrolled in another study of a palliative care patient/caregiver intervention
- Diagnoses of both cancer and advanced HF
- Lung cancer with a driver mutation (e.g., EGFR) that confers a favorable prognosis and does not follow typical trajectory
- Patients with > 1 visit to Outpatient Supportive Oncology/Cardiology visit
- Patients with last visit to Outpatient Supportive Oncology/Cardiology < 3 months ago
- Living in a facility (subacute rehab, long-term care facility, hospice facility or residence)
- Callahan 6-Item Cognitive Screening score ≤3
Where in United States
- Mount Sinai HospitalNew York, United StatesContact: Laura Gelfman, MD, MPHTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Tier-Palliative CareTreatment being tested
Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
- Usual CareNo study treatment, for comparison
Patients will be cared for by the physician who treats their serious illness (cardiologist, oncologist, primary treating clinician) and other illnesses.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- TIER-PALLIATIVE CARE: A Population-based Care Delivery Model to Match Evolving Patient Needs and Palliative Care Services for Community-based Patients With Heart Failure or Cancer
- Plain-language title
- Palliative Care Model for People With Advanced Heart Failure or CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 October 2026