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

Study acronym: TIER-PC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years later Aug 19, 2026 → Sep 1, 2030
See other at-risk trials from Icahn School of Medicine at Mount Sinai

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Aug 19, 2026 to Sep 1, 2030
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 8 entries
  2. Minor Trial status: Enrolling by Invitation to Recruiting
    • Interventions: Tier - Palliative Care (Behavioral) to Tier-Palliative Care (Behavioral)
    • Site details revised
    v5
  3. Notable Enrollment target: 28 to 60
    • Primary and study completion dates: May 31, 2025 to Aug 19, 2026
    • Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v4
  4. Notable Enrollment target: 60 to 28
    • Start date: Jan 26, 2024 to Jan 31, 2025
    • Primary and study completion dates: Jul 2025 to May 31, 2025
    v3
  5. Minor Start date changed from estimate of Jan 2024 to Jan 26, 2024v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06228209
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: National Institute of Nursing Research (NINR)
Conditions
(from sponsor)
Advanced Heart Failure, Advanced Non-Colorectal Gastointestinal Cancer, Advanced Lung Cancer
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov