NCT07391956 Tier Palliative Care For Patients With Advanced Heart Failure or Cancer
| NCT ID | NCT07391956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Advanced Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-07-10 |
| Primary Completion | 2030-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2026-07-10 with a primary completion date of 2030-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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) or tripe negative breast cancer with one hospitalization within the last 6 months * KPS \> or = 50% (ECOG 0, 1 or 2) * \> 2 outpatient MSHS visits in prior 12 months * Manhattan or Queens residence * Capacity to provide informed consent * English or Spanish fluency * \> or = 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
Contact & Investigator
Laura Gelfman
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT07391956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07391956 currently recruiting?
Yes, NCT07391956 is actively recruiting participants. Contact the research team at Christian.Espino@mssm.edu for enrollment information.
Where is the NCT07391956 trial being conducted?
This trial is being conducted at Astoria, United States, New York, United States, New York, United States, New York, United States and 1 additional location.
Who is sponsoring the NCT07391956 clinical trial?
NCT07391956 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Laura Gelfman at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 400 participants.
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