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NCT Number: NCT06228209

Tier - Palliative Care For Patients With Advanced 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.

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Key information

Conditions

Advanced Heart Failure Advanced Lung Cancer Advanced Non-Colorectal Gastointestinal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

New York, 10029, United States

Location status: Recruiting

Location contact

Laura Gelfman

PRINCIPAL_INVESTIGATOR

Laura Gelfman, MD, MPH

CONTACT

[email protected]

About this study

The study aims are:

To evaluate the feasibility of enrolling patients into a study of TIER-PC; and To provide data on subject retention, randomization success, intervention fidelity and estimates of the efficacy of the TIER-PC intervention in improving patients' symptoms and quality of life, and reducing emergency department visits and hospitalizations.

This study will enroll 60 subjects with advanced non-colorectal gastrointestinal or lung cancer or advanced HF, 30 of which will be randomized to receive the study intervention and 30 of which will be randomized to receive usual care.

The expected study duration is 18 months from enrollment initiation to completion of data analysis consisting of a 52- week active enrollment period, a 3 month follow up period, and a three month data analysis period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) 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

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

Treatment and study plan

Tier-Palliative Care

Behavioral

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.

Other names: Tier-PC

Primary outcomes

  1. The proportion of screened eligible patients

    Time frame: 3 months

    The proportion of screened eligible patients that are enrolled in the trial.

Secondary outcomes

  1. The proportion of patients completing the final 3-month visit

    Time frame: 3 months

    The proportion of the patients completing the final 3-month visit among all enrolled patients.

  2. Number of TIER-PC intervention visits received per patient per month

    Time frame: 3 months

    The fidelity to intervention is defined as the number of TIER-PC intervention visits received per patient per month in the TIER-PC arm during the follow-up period.

  3. Edmonton Symptom Assessment Scale (ESAS)

    Time frame: 3 months

    Patient symptoms will be measured (e.g., pain, shortness of breath) using the 9-item Edmonton Symptom Assessment Scale (ESAS) validated for serious illness. Each item is 10-point scale, total score ranges 0 (no symptoms) - 90 (worst severity), with higher scores indicating worse symptom severity.

  4. Quality of Life measured using Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)

    Time frame: 3 months

    Quality of life (QoL) using the 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 from 0 (not at all) - 4 (very much). Total score ranges 0-184, with higher scores indicating better quality of life.

  5. Number of participant emergency department (ED) visits

    Time frame: 3 months

    Number of participant ED visits

  6. Number of participant hospitalizations

    Time frame: 3 months

    Number of participant hospitalizations

  7. Number of participant hospital days

    Time frame: 3 months

    Number of participant hospital days

  8. Patient-Reported Goals of Care Discussion (GOCD)

    Time frame: 3 months

    Patient report of goals of care discussions. Single item on GOCD with clinician. Response: Yes/No

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Espino

CONTACT

[email protected]

212-421-4632

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study 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

Acronym: TIER-PC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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