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Tier Palliative Care For Patients With Advanced Heart Failure or Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests home-based palliative care for adults with advanced heart failure or certain advanced cancers. Palliative care helps manage symptoms and care needs. The program adds more care team members as symptoms worsen and daily tasks become harder.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have advanced heart failure with 2 hospital stays for heart failure in the past 12 months; OR meet the cancer requirement below.
  • Have advanced lung cancer, triple-negative breast cancer, or cancer of the pancreas, stomach, liver or bile ducts, small bowel, or esophagus, with 1 hospital stay in the past 6 months.
  • Have a KPS score of at least 50% or an ECOG score of 0, 1, or 2. These scores measure how well you can do daily tasks.
  • Have had more than 2 outpatient visits in the Mount Sinai Health System in the past 12 months.
  • Live in Manhattan or Queens.
  • Be able to understand the study and agree to take part.
  • Speak English or Spanish fluently.
  • Be at least 18 years old.

Who can't join

  • Have both cancer and advanced heart failure.
  • Have lung cancer with a gene change, such as EGFR, that gives a better outlook and a different course than usual.
  • Have had more than 1 visit to Outpatient Supportive Oncology or Cardiology, which provide supportive care for cancer or heart disease.
  • Had your last Outpatient Supportive Oncology or Cardiology visit less than 3 months ago.
  • Have received a device that helps the heart pump blood or had a heart transplant.
  • Receive hospice care before joining, or are in another study testing palliative care for patients or caregivers.
  • Live in a care facility, such as a rehab center, long-term care facility, or hospice.
  • Score 3 or less on the Callahan 6-Item Cognitive Screening test, which checks memory and thinking.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (5)

NY