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

NCT ID: NCT06228209

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-08-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Tier - Palliative Care

Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.

Group Type: EXPERIMENTAL

Tier - Palliative Care

Intervention Type: BEHAVIORAL

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.

Usual care

Patients will be cared for by the physician who treats their serious illness (cardiologist, oncologist, primary treating clinician) and other illnesses.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Laura Gelfman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura P Gelfman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Hospital

New York, New York, United States

Countries

United States

Other Identifiers

1R56NR020624-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-22-00591

Identifier Type: -

Identifier Source: org_study_id