Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer

Advanced Lung Cancer Clinical Trial

— TIER-PC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228209
• Other study ID #: STUDY-22-00591
• Secondary ID: 1R56NR020624-01
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Laura P Gelfman, MD, MPH
• Phone: 212-241-4323
• Email: laura.gelfman[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Heart Failure
• Advanced Lung Cancer
• Gastrointestinal Neoplasms
• Heart Failure
• Intestinal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of screened eligible patients	The proportion of screened eligible patients that are enrolled in the trial.	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participant emergency department (ED) visits	Number of participant ED visits	3 months
Secondary	Number of participant hospitalizations	Number of participant hospitalizations	3 months
Secondary	Number of participant hospital days	Number of participant hospital days	3 months
Secondary	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