Tier Palliative Care For Patients With Advanced Heart Failure or Cancer
TIER-PC
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
1 other identifier
interventional
400
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2032
February 6, 2026
February 1, 2026
4.6 years
January 27, 2026
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Edmonton Symptom Assessment Scale (ESAS)
Patient symptoms: Edmonton Symptom Assessment Scale (ESAS), 9 items, each item is scored on a 10-point scale, total score ranges from 0-90, higher scores indicate more symptoms.
12 months
Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)
Patient quality of life: Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal), a 46-item QoL questionnaire validated in patients with advanced disease. Each item is scored on a 5-point likert scale. Total score ranges from 0-184, higher scores indicate better quality of life
12 months
Patient-reported goals of care discussion
Patient-reported Goals of Care Discussions: "Have you ever discussed with this doctor the kind of medical care you would want if you were too sick to speak for yourself?" Response: Yes/No
12 months
Secondary Outcomes (5)
Generalized Anxiety Disorder-7 (GAD-7)
12 months
Family Satisfaction with End-of-Life Care (FAMCARE-10)
12 months
Number of hospital admissions
12 months
Number of hospital days
12 months
Number of emergency department (ED) visits
12 months
Study Arms (2)
Tier-Palliative Care
EXPERIMENTALPatients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician based on symptom burden and function.
Augmented Control
ACTIVE COMPARATORVisits to the patient from a CHW without training in heart failure, cancer or palliative care.
Interventions
Usual Care plus the addition of a community health worker who will serve as a health coach for the participant.
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. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines.
Eligibility Criteria
You may qualify if:
- 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) or tripe negative breast cancer with one hospitalization within the last 6 months
- KPS \> or = 50% (ECOG 0, 1 or 2)
- \> 2 outpatient MSHS visits in prior 12 months
- Manhattan or Queens residence
- Capacity to provide informed consent
- English or Spanish fluency
- \> or = 18 years of age
You may not qualify if:
- 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
- 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
- Living in a facility (subacute rehab, long-term care facility, hospice facility or residence)
- Callahan 6-Item Cognitive Screening score ≤3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Mount Sinai Queens
Astoria, New York, 11102, United States
Mount Sinai Downtown
New York, New York, 10003, United States
Mount Sinai West
New York, New York, 10019, United States
Mount Sinai Morningside
New York, New York, 10025, United States
Mount Sinai Hospital
New York, New York, 10029, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Gelfman
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single blind control
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 27, 2026
First Posted
February 6, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
November 30, 2030
Study Completion (Estimated)
January 31, 2032
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 9 months and ending 36 months following article publication.
- Access Criteria
- Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to Christian.Espino@mssm.edu . To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).
All of the individual participant data collected during the trial, after deidentification.