NCT06228209

Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer

Tier - Palliative Care: A Population-based Care Delivery Model to Match Evolving Patient Needs to Palliative Care Services for Community-based Patients With Heart Failure or Cancer

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Heart Failure
• Advanced Non-colorectal Gastro-intestinal Cancer
• Advanced Lung Cancer

Interventions

Type	Name	Description
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. 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.

Timeline

• Start date: 2025-01-31
• Primary completion: 2026-08-19
• Completion: 2026-08-19
• First posted: 2024-01-29
• Last updated: 2025-09-04

Locations

1 site across 1 country: United States