Tiered Palliative Care for Patients with Advanced Heart Failure or Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TIER-PC adapts the Mount Sinai PC@H program by adding more care team members as patients’ needs change. The study uses a randomized design to compare the tiered, home-based palliative care model against usual care, focusing on symptoms, quality of life, and goals-of-care documentation. Interventions include CHWs, social workers, and advanced practice nurses delivering care through in-person visits and video or phone contacts, with 24/7 physician advice access. Outcomes will also look at healthcare utilization and caregiver well-being. Participants are supported at Mount Sinai-affiliated sites in New York City.

Why it matters

Who can join: the full rules

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

Where it's running

• Mount Sinai Queens
  Astoria, New York, United States Recruiting
• Mount Sinai Downtown
  New York, New York, United States Recruiting
• Mount Sinai West
  New York, New York, United States Recruiting
• Mount Sinai Morningside
  New York, New York, United States Recruiting
• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Laura Gelfman — Icahn School of Medicine at Mount Sinai
• Study coordinator: Christian Espino
• Email: Christian.Espino@mssm.edu
• Phone: 212-421-4632

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.