RecruitingNot applicableNCT07391956
Official study title

Tier Palliative Care For Patients With Advanced Heart Failure or Cancer

Study 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.

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Key things to know

Main goalHealth Services Research

This describes the study’s primary purpose.

What is being studiedTier-Palliative Care and Community Health Worker

The study team can explain what participation involves.

Who it may be forMET

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 14, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Icahn School of Medicine at Mount Sinai

Study sponsor

01
Study overview

What this study is about

Purpose
Health Services Research
Study type
Interventional
Phase
Not applicable
Sponsor
Icahn School of Medicine at Mount Sinai
Interventions being studied
Behavioral: Tier-Palliative Care; Behavioral: Community Health Worker
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mount Sinai QueensAstoria, New York
  • Mount Sinai DowntownNew York, New York
  • Mount Sinai WestNew York, New York
  • Mount Sinai MorningsideNew York, New York
  • Mount Sinai HospitalNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 14, 2026. Always confirm current availability with the study team.

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