RecruitingRecruiting
Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer
NCT06228209 · Icahn School of Medicine at Mount Sinai
In plain English
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Official title
TIER-PALLIATIVE CARE: A Population-based Care Delivery Model to Match Evolving Patient Needs and Palliative Care Services for Community-based Patients With Heart Failure or Cancer
About this study
The study aims are:
To evaluate the feasibility of enrolling patients into a study of TIER-PC; and To provide data on subject retention, randomization success, intervention fidelity and estimates of the efficacy of the TIER-PC intervention in improving patients' symptoms and quality of life, and reducing emergency department visits and hospitalizations.
This study will enroll 60 subjects with advanced non-colorectal gastrointestinal or lung cancer or advanced HF, 30 of which will be randomized to receive the study intervention and 30 of which will be randomized to receive usual care.
The expected study duration is 18 months from enrollment initiation to completion of data analysis consisting of a 52- week active enrollment period, a 3 month follow up period, and a three month data analysis period.
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) 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
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-01-31
Estimated completion: 2026-08-19
Last updated: 2026-07-15
Interventions
Behavioral: Tier-Palliative Care
Primary outcomes
- • The proportion of screened eligible patients (3 months)
Sponsor
Icahn School of Medicine at Mount Sinai · other
With: National Institute of Nursing Research (NINR)
Contacts & investigators
ContactChristian Espino · contact · Christian.Espino@mssm.edu · 212-421-4632
InvestigatorLaura Gelfman, MD, MPH · principal_investigator, Icahn School of Medicine at Mount Sinai
All locations (1)
Mount Sinai HospitalRecruiting
New York, New York, United States