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Palliative Care for Heart Failure or Cancer (TIER-PC Trial)

N/A

Recruiting

Led By Laura P Gelfman, MD, MPH

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

> 18 years of age

Capacity to provide informed consent

Must not have

Diagnoses of both cancer and advanced HF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial, called TIER-PC, is a way of delivering palliative care that adjusts based on a patient's needs. It is based on a program called PC@H, which provides pall

Who is the study for?

This trial is for adults with advanced heart failure or cancer (intestinal, gastrointestinal, stomach, lung) who need different levels of palliative care. The care level adjusts as symptoms and personal care abilities change. Patients must be able to receive home-based care.

What is being tested?

The TIER-PC model is being tested to provide adaptive palliative care at home. It adds more healthcare professionals to the patient's team as their condition worsens, ranging from a community health worker to a physician in the most severe cases.

What are the potential side effects?

Since this trial focuses on non-medical interventions like palliative care services rather than drugs or medical procedures, it does not have typical side effects. However, changes in emotional well-being due to varying levels of support may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I understand and can agree to the study's procedures and risks.

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I have had multiple hospital visits due to heart failure or cancer.

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I can care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with both cancer and advanced heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of screened eligible patients

Secondary study objectives

Edmonton Symptom Assessment Scale (ESAS)

Number of TIER-PC intervention visits received per patient per month

Number of participant emergency department (ED) visits

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tier - Palliative CareExperimental Treatment1 Intervention

Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.

Group II: Usual careActive Control1 Intervention

Patients will be cared for by the physician who treats their serious illness (cardiologist, oncologist, primary treating clinician) and other illnesses.

0 / 5Eligibility criteria met