Tier - Palliative Care for Patients with Advanced Heart Failure or Cancer

Phase

N/A

Condition

Heart Failure

Chest Pain

Gastrointestinal Diseases And Disorders

Treatment

Tier - Palliative Care

Clinical Study ID

NCT06228209

STUDY-22-00591

1R56NR020624-01

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Advanced Heart Failure (HF) with two HF-related hospitalizations within the last 12months or
Advanced lung or non-colorectal gastrointestinal cancer (pancreatic, gastric,hepatobiliary, small bowel, esophageal) with one hospitalization within the last 6months
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

Exclusion Criteria:

Diagnoses of both cancer and advanced HF
Lung cancer with a driver mutation (e.g., EGFR) that confers a favorable prognosisand 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 apalliative care patient/caregiver intervention
Living in a facility (subacute rehab, long-term care facility, hospice facility orresidence)
Callahan 6-Item Cognitive Screening score ≤3

Study Design

Tier - Palliative Care

January 31, 2025

May 31, 2025

Study Description

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.

Connect with a study center

Mount Sinai Hospital
New York, New York 10029
United States
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.