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

NCT06228209 | Enrolling By Invitation

• 2 other identifiers: STUDY-22-005911R56NR020624-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

palliative care; community-based; advanced heart failure; advanced cancer

Outcome Measures

Primary Outcomes (1)

• The proportion of screened eligible patients

  The proportion of screened eligible patients that are enrolled in the trial.

  3 months

Secondary Outcomes (8)

• The proportion of patients completing the final 3-month visit

  3 months

• Number of TIER-PC intervention visits received per patient per month

  3 months

• Edmonton Symptom Assessment Scale (ESAS)

  3 months

• Quality of Life measured using Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)

  3 months

• Number of participant emergency department (ED) visits

  3 months

Study Arms (2)

Tier - Palliative Care

EXPERIMENTAL

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

Behavioral: Tier - Palliative Care

Usual care

NO INTERVENTION

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

Interventions

Tier - Palliative Care 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.

Tier - Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Study Officials

• Laura P Gelfman, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Before each research interview, subjects will be reminded not to tell the research coordinator to which study group they were assigned. In case of inadvertent unblinding of a blinded study team member, this team member will have to report the unblinding event to the PI. The study team member will not be allowed to collect data for the subjects whose group allocation they have inadvertently been unblinded to. A different, fully blinded study team member has to collect data for the respective subjects henceforth.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to Arushi.Arora@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, to be determined.

Locations

US (1)