Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer (NCT06228209) | Clinical Trial Compass
RecruitingNot Applicable
Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer
United States60 participantsStarted 2025-01-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) 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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.