Recruiting

Palliative Care

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07391956

Conditions

Advanced Heart Failure

Advanced Non-Colorectal Gastrointestinal Cancer

Advanced Lung Cancer

Advanced Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tier-Palliative Care

Community Health Worker

Study Details

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.

Conditions

Advanced Heart Failure

Advanced Non-Colorectal Gastrointestinal Cancer

Advanced Lung Cancer

Advanced Triple Negative Breast Cancer

Study ID

NCT07391956

Start date

Jul 10, 2026

Status verified date

Jul, 2026

Completion date

Jan 31, 2032

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion 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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Tier-Palliative Care

Patients/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.

active comparator: Augmented Control

Visits to the patient from a CHW without training in heart failure, cancer or palliative care.

Interventions

Tier-Palliative Care

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.

Community Health Worker

Usual Care plus the addition of a community health worker who will serve as a health coach for the participant.

Primary outcome measure

  • Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: 12 months ]
  • Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal) [ Time Frame: 12 months ]
  • Patient-reported goals of care discussion [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Queens

Recruiting

Astoria, New York, United States, 11102

Mount Sinai Downtown

Recruiting

New York, New York, United States, 10003

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Contacts

Laura Gelfman, MD, MPH

Laura.Gelfman@mssm.edu

Mount Sinai Morningside

Recruiting

New York, New York, United States, 10025

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Laura Gelfman, MD, MPH

Laura.Gelfman@mssm.edu

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Sep 14, 2026

Last verified

Jul, 2026

Keywords

  • palliative care
  • community-based
  • advanced heart failure
  • advanced cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-09-14.