Trials / Not Yet Recruiting

Not Yet RecruitingNCT07391956

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 and Palliative Care Services for Community-based Patients With Heart Failure or Cancer

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 400 (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 objective of this randomized controlled trial is to study the impact of a novel home based palliative care intervention on patients' symptoms, quality of life, and completion of goals of care documentation. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver anxiety, satisfaction with care and post-traumatic symptoms. Patients randomized to the intervention will be scheduled for Tier-PC visit community health work to allocate to Tier-PC tier. Visits will combine a combination of video-teleconferencing technology and in person visits. Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.

Conditions

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. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines.
BEHAVIORAL	Community Health Worker	Usual Care plus the addition of a community health worker who will serve as a health coach for the participant.

Timeline

Start date: 2026-05-01
Primary completion: 2030-11-30
Completion: 2032-01-31
First posted: 2026-02-06
Last updated: 2026-02-06

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT07391956. Inclusion in this directory is not an endorsement.