ENROLLING_BY_INVITATION

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-31
Study Completion:2026-08-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT06228209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Advanced Heart Failure (HF) with two HF-related hospitalizations within the last 12 months or
  2. * Advanced lung or non-colorectal gastrointestinal cancer (pancreatic, gastric, hepatobiliary, small bowel, esophageal) with one hospitalization within the last 6 months
  3. * KPS \> 50% (ECOG 0, 1 or 2)
  4. * \> 2 outpatient MSHS visits in prior 12 months
  5. * Manhattan residence
  6. * Capacity to provide informed consent
  7. * English or Spanish fluency
  8. * \> 18 years of age
  1. * Diagnoses of both cancer and advanced HF
  2. * Lung cancer with a driver mutation (e.g., EGFR) that confers a favorable prognosis and does not follow typical trajectory
  3. * Patients with \> 1 visit to Outpatient Supportive Oncology/Cardiology visit
  4. * Patients with last visit to Outpatient Supportive Oncology/Cardiology \< 3 months ago
  5. * Previous receipt of a ventricular assist device or previous heart transplantation
  6. * Receiving hospice care prior to study enrollment or enrolled in another study of a palliative care patient/caregiver intervention
  7. * Living in a facility (subacute rehab, long-term care facility, hospice facility or residence)
  8. * Callahan 6-Item Cognitive Screening score ≤3

Contacts and Locations

Principal Investigator

Laura P Gelfman, MD, MPH
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Hospital
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Laura P Gelfman, MD, MPH, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-31
Study Completion Date2026-08-19

Study Record Updates

Study Start Date2025-01-31
Study Completion Date2026-08-19

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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