Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer (TIER-PC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Heart Failure; Advanced Lung Cancer; Advanced Non-colorectal Gastro-intestinal Cancer
• Intervention / Treatment: Behavioral: Tier - Palliative Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura P Gelfman, MD, MPH; Phone Number: 212-241-4323; Email: laura.gelfman@mssm.edu
• Study Contact Backup: Name: Arushi Arora, MPH; Phone Number: 212-241-4323; Email: arushi.arora@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Arushi Arora; Email: Arushi.Arora@mssm.edu
      • Contact: Christian Espino; Email: Christian.Espino@mssm.edu
      • Principal Investigator: Laura Gelfman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tier - Palliative Care; Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.	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. 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.
No Intervention: Usual care; Patients will be cared for by the physician who treats their serious illness (cardiologist, oncologist, primary treating clinician) and other illnesses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of screened eligible patients	The proportion of screened eligible patients that are enrolled in the trial.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients completing the final 3-month visit	The proportion of the patients completing the final 3-month visit among all enrolled patients.	3 months
Number of TIER-PC intervention visits received per patient per month	The fidelity to intervention is defined as the number of TIER-PC intervention visits received per patient per month in the TIER-PC arm during the follow-up period.	3 months
Edmonton Symptom Assessment Scale (ESAS)	Patient symptoms will be measured (e.g., pain, shortness of breath) using the 9-item Edmonton Symptom Assessment Scale (ESAS) validated for serious illness. Each item is 10-point scale, total score ranges 0 (no symptoms) - 90 (worst severity), with higher scores indicating worse symptom severity.	3 months
Quality of Life measured using Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)	Quality of life (QoL) using the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal), a 46-item QoL questionnaire validated in patients with advanced disease. Each item is scored on a 5-point Likert scale from 0 (not at all) - 4 (very much). Total score ranges 0-184, with higher scores indicating better quality of life.	3 months
Number of participant emergency department (ED) visits	Number of participant ED visits	3 months
Number of participant hospitalizations	Number of participant hospitalizations	3 months
Number of participant hospital days	Number of participant hospital days	3 months
Patient-Reported Goals of Care Discussion (GOCD)	Patient report of goals of care discussions. Single item on GOCD with clinician. Response: Yes/No	3 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Laura P Gelfman, MD, MPH, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: palliative care; advanced cancer; community-based; advanced heart failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Heart Diseases; Cardiovascular Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Heart Failure; Gastrointestinal Neoplasms; Intestinal Neoplasms
• Other Study ID Numbers: STUDY-22-00591; 1R56NR020624-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

For individual participant data meta-analysis. Proposals should be directed to Arushi.Arora@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, to be determined.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No