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 is an innovative model of delivering palliative care that tailors the level of care to patients with advanced heart failure or cancer based on their symptoms and functional status. The program adapts the Mount Sinai Palliative Care at Home initiative, utilizing a tiered approach where patients receive varying levels of support from community health workers, social workers, and advanced practice nurses as their needs evolve. The study aims to evaluate the feasibility of patient enrollment, retention, and the effectiveness of the intervention in improving quality of life and reducing hospital visits. A total of 60 subjects will be enrolled, with half receiving the TIER-PC intervention and the other half receiving standard care.

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) 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

Where it's running

• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Laura Gelfman, MD, MPH — 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.