NCT06228209Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 19 Jan 2024
- Start date
- 31 Jan 2025
- Primary completion date
- 1 Sept 2030
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Heart failure, Lung cancer, Colorectal cancer
- NCT number
- NCT06228209
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 31 Jan 2025 to the primary completion date, 1 Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Diagnoses of both cancer and advanced HF
Lab values
- Lung cancer with a driver mutation (e.g., EGFR) that confers a favorable prognosis and does not follow typical trajectory
Other
- Patients with \> 1 visit to Outpatient Supportive Oncology/Cardiology visit
- Patients with last visit to Outpatient Supportive Oncology/Cardiology \< 3 months ago
- Living in a facility (subacute rehab, long-term care facility, hospice facility or residence)
- Callahan 6-Item Cognitive Screening score ≤3
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.