Tier Palliative Care For Patients With Advanced Heart Failure or Cancer (TIER-PC)

February 2, 2026 updated by: Laura Gelfman, Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this randomized controlled trial is to study the impact of a novel home based palliative care intervention on patients' symptoms, quality of life, and completion of goals of care documentation. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver anxiety, satisfaction with care and post-traumatic symptoms. Patients randomized to the intervention will be scheduled for Tier-PC visit community health work to allocate to Tier-PC tier. Visits will combine a combination of video-teleconferencing technology and in person visits. Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Astoria, New York, United States, 11102
        • Mount Sinai Queens
      • New York, New York, United States, 10019
      • New York, New York, United States, 10029
      • New York, New York, United States, 10025
        • Mount Sinai Morningside
      • New York, New York, United States, 10003
        • Mount Sinai Downtown

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Other Names:
  • Tier-PC
Active Comparator: Augmented Control
Visits to the patient from a CHW without training in heart failure, cancer or palliative care.
Behavioral: Community Health Worker
Usual Care plus the addition of a community health worker who will serve as a health coach for the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edmonton Symptom Assessment Scale (ESAS)
Time Frame: 12 months
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)
Time Frame: 12 months
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
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 12 months
Generalized Anxiety Disorder-7 (GAD-7), a 7-item scale, Full scale from 0-21, higher scores indicates more anxiety.
12 months
Family Satisfaction with End-of-Life Care (FAMCARE-10)
Time Frame: 12 months
FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. Full scale ranges 0-20, with higher scores indicating higher satisfaction.
12 months
Number of hospital admissions
Time Frame: 12 months
Number of hospital admissions: Acute care utilization as measured by the number of hospital admissions
12 months
Number of hospital days
Time Frame: 12 months
Number of hospital days: Acute care utilization as measured by the number of hospital days
12 months
Number of emergency department (ED) visits
Time Frame: 12 months
Number of emergency department (ED) visits: Acute care utilization as measured by the number of ED visits
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Laura Gelfman, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 30, 2030

Study Completion (Estimated)

January 31, 2032

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-22-00591 R01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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