Palliative care for patients with advanced heart failure or cancer
Tier - Palliative Care: A Population-based Care Delivery Model to Match Evolving Patient Needs to Palliative Care Services for Community-based Patients With Heart Failure or Cancer
This study is testing a new palliative care program for people with advanced heart failure or cancer to see if it can improve their quality of life and reduce hospital visits compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06228209 on ClinicalTrials.gov |
What this trial studies
TIER-PC is an innovative model of delivering palliative care that tailors the level of care to patients with advanced heart failure or cancer based on their symptoms and functional status. The program adapts the Mount Sinai Palliative Care at Home initiative, utilizing a tiered approach where patients receive varying levels of support from community health workers, social workers, and advanced practice nurses as their needs evolve. The study aims to evaluate the feasibility of patient enrollment, retention, and the effectiveness of the intervention in improving quality of life and reducing hospital visits. A total of 60 subjects will be enrolled, with half receiving the TIER-PC intervention and the other half receiving standard care.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with advanced heart failure or specific types of advanced cancer who have had recent hospitalizations and can provide informed consent.
Not a fit: Patients with both cancer and advanced heart failure or those receiving hospice care prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with advanced heart failure or cancer by providing timely and appropriate palliative care.
How similar studies have performed: Other studies have shown promise with similar palliative care approaches, indicating potential for success in this novel adaptation.
Eligibility criteria
Show full inclusion / exclusion 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) 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
Where this trial is running
New York, New York
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Laura P Gelfman, MD, MPH — Icahn School of Medicine at Mount Sinai
- Study coordinator: Laura P Gelfman, MD, MPH
- Email: laura.gelfman@mssm.edu
- Phone: 212-241-4323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.