Clinical trial NCT06228209: Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Heart Failure
Advanced Non-colorectal Gastro-intestinal Cancer
Advanced Lung Cancer
Keywords: palliative care
community-based
advanced heart failure
advanced cancer
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-01-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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

Primary outcomes:
measure: The proportion of screened eligible patients
timeFrame: 3 months
Secondary outcomes:
measure: The proportion of patients completing the final 3-month visit
timeFrame: 3 months
measure: Number of TIER-PC intervention visits received per patient per month
timeFrame: 3 months
measure: Edmonton Symptom Assessment Scale (ESAS)
timeFrame: 3 months
measure: Quality of Life measured using Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)
timeFrame: 3 months
measure: Number of participant emergency department (ED) visits
timeFrame: 3 months
measure: Number of participant hospitalizations
timeFrame: 3 months
measure: Number of participant hospital days
timeFrame: 3 months
measure: Patient-Reported Goals of Care Discussion (GOCD)
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Laura P Gelfman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: