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 and Palliative Care Services for Community-based Patients With Heart Failure or Cancer

Overview

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 objective of this randomized controlled trial is to study the impact of a novel home based palliative care intervention on patients' symptoms, quality of life, and completion of goals of care documentation. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver anxiety, satisfaction with care and post-traumatic symptoms. Patients randomized to the intervention will be scheduled for Tier-PC visit community health work to allocate to Tier-PC tier. Visits will combine a combination of video-teleconferencing technology and in person visits. Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.

Interventions

• Behavioral Tier-Palliative Care
  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. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines.
• Behavioral Community Health Worker
  Usual Care plus the addition of a community health worker who will serve as a health coach for the participant.

Primary outcome measures

• Edmonton Symptom Assessment Scale (ESAS) [Time frame: 12 months]
• Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal) [Time frame: 12 months]
• Patient-reported goals of care discussion [Time frame: 12 months]

Secondary outcome measures (5)

• Generalized Anxiety Disorder-7 (GAD-7) [Time frame: 12 months]
• Family Satisfaction with End-of-Life Care (FAMCARE-10) [Time frame: 12 months]
• Number of hospital admissions [Time frame: 12 months]
• Number of hospital days [Time frame: 12 months]
• Number of emergency department (ED) visits [Time frame: 12 months]

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) or tripe negative breast cancer with one hospitalization within the last 6 months
• KPS > or = 50% (ECOG 0, 1 or 2)
• > 2 outpatient MSHS visits in prior 12 months
• Manhattan or Queens residence
• Capacity to provide informed consent
• English or Spanish fluency
• > or = 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 5 centers

• Mount Sinai Queens — Astoria
• Mount Sinai Downtown — New York
• Mount Sinai West — New York
• Mount Sinai Morningside — New York
• Mount Sinai Hospital — New York

Identifiers

NCT: NCT07391956 · STUDY-22-00591 R01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗