Tier Palliative Care For Patients With Advanced Heart Failure or Cancer

Part of paid clinical trials in Astoria, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07391956
Status
Not Yet Recruiting

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Conditions

  • Advanced Heart Failure
  • Advanced Lung Cancer
  • Advanced Non-Colorectal Gastrointestinal Cancer
  • Advanced Triple Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines.
  • Community Health Worker — BEHAVIORAL
    Usual Care plus the addition of a community health worker who will serve as a health coach for the participant.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Feb 2026
Primary completion
Nov 30, 2030
Completion
Jan 31, 2032

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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 based on symptom burden and function.
  • Active Comparator: Augmented Control
    Visits to the patient from a CHW without training in heart failure, cancer or palliative care.

Primary Outcome Measure

Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: 12 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mount Sinai QueensAstoriaNew York11102-
Mount Sinai DowntownNew YorkNew York10003-
Mount Sinai HospitalNew YorkNew York10029
Laura Gelfman, MD, MPH
[email protected]
Mount Sinai MorningsideNew YorkNew York10025-
Mount Sinai WestNew YorkNew York10019
Laura Gelfman, MD, MPH
[email protected]

Find similar trials in Astoria, NY

By research site
Mount Sinai Queens· Astoria, NYMount Sinai Downtown· New York, NYMount Sinai Hospital· New York, NYMount Sinai Morningside· New York, NYMount Sinai West· New York, NY

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