Tier Palliative Care for Heart Failure and Cancer

(TIER-PC Trial)

Not yet recruiting at 4 trial locations
CE
Overseen ByChristian Espino
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering palliative care for individuals with advanced heart failure or specific types of cancer. The goal is to provide appropriate care at the right time, adjusting support as a patient's condition evolves. Depending on their needs, patients may receive care from a team that includes a community health worker, social worker, nurse, and doctor. Suitable candidates have advanced heart failure with recent hospitalizations or certain cancers with recent hospital stays and reside in Manhattan or Queens. This trial may benefit those seeking to manage symptoms and improve quality of life while remaining at home. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could enhance home-based symptom management and quality of life.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this adaptive palliative care model is safe for patients with heart failure and cancer?

Research has shown that palliative care can enhance the quality of life for individuals with heart failure and advanced cancer. This care focuses on comfort and support, potentially leading to better health outcomes. Although specific safety data for the Tier Palliative Care model is limited, it builds on existing palliative care programs.

Palliative care typically involves a team of healthcare professionals who collaborate to manage symptoms and provide emotional support. Patients generally receive this approach well. It often includes less invasive treatments aimed at improving daily life rather than curing the disease. These factors suggest that the Tier Palliative Care model is likely safe and well-tolerated, based on the established safety of similar palliative care programs.

Prospective trial participants should discuss any concerns with the trial team. The team can provide information on what to expect and how they will address specific needs.12345

Why are researchers excited about this trial?

Researchers are excited about Tier Palliative Care for heart failure and cancer because it takes a comprehensive, team-based approach. Unlike standard treatments that might focus primarily on medications or individual therapies, this method involves an interdisciplinary team, including a social worker, nurse, community health worker, nurse practitioner, and physician. This team collaborates to address the patient's symptoms and overall function, aiming for a more holistic improvement in quality of life. By personalizing care to meet the unique needs of patients and caregivers, it offers a more tailored support system, which could be a game-changer in managing complex conditions like heart failure and cancer.

What evidence suggests that this adaptive palliative care model is effective for heart failure and cancer?

Research has shown that tiered palliative care, which participants in this trial may receive, can improve the quality of life for patients with advanced heart failure or cancer. These patients often experience many difficult symptoms. Studies have found that palliative care helps manage these symptoms, reduces hospital visits, and increases patient satisfaction. A team of healthcare professionals, including social workers and nurses, collaborates to provide comprehensive support. The care adjusts to meet the changing needs of patients over time. Overall, evidence supports its effectiveness in managing complex symptoms and enhancing the quality of life for patients with serious illnesses.678910

Who Is on the Research Team?

LG

Laura Gelfman

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for patients with advanced heart failure or cancer (gastrointestinal, lung, breast) who need different levels of palliative care. The right candidates are those whose symptoms and functional abilities vary over time.

Inclusion Criteria

Manhattan or Queens residence
I can take care of myself but may not be able to do active work.
I have visited an MSHS outpatient clinic more than twice in the last year.
See 4 more

Exclusion Criteria

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
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tier-Palliative Care Intervention

Participants receive home-based palliative care tailored to their symptom burden and function, involving a community health worker, social worker, nurse, nurse practitioner, and physician as needed.

12 months
Combination of video-teleconferencing and in-person visits

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessment of symptoms, quality of life, and healthcare utilization.

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Tier Palliative Care

Trial Overview

The study tests a tiered palliative care model that adjusts the care team's composition based on patient needs. It ranges from community health workers for mild cases to adding social workers, nurses, and physicians as conditions worsen.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Tier-Palliative CareExperimental Treatment1 Intervention
Group II: Augmented ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40147986/

Interventions to enable and reach patients with heart failure ...

Division of Supportive and Palliative Care, National Cancer Centre Singapore ... Keywords: Heart failure; PALLIATIVE CARE; Patients. © Author(s) (or ...

Tier - Palliative Care For Patients With Advanced Heart ...

Advanced Heart Failure (HF) with two HF-related hospitalizations within the last 12 months or; Advanced lung or non-colorectal gastrointestinal cancer ( ...

Tier - Palliative Care for Patients with Advanced Heart ...

Tier - Palliative Care for Patients with Advanced Heart Failure or Cancer. ID#: NCT06228209. Age: 18 years - 66+. Gender: All. Healthy Subjects: No. Study Phase ...

Interventions to enable and reach patients with heart failure ...

Challenges for Patients Dying of Heart Failure and Cancer. Circ Heart Fail 2022;15:e009922. doi:10.1161/CIRCHEARTFAILURE.122.009922 · Google Scholar.

Palliative and End-of-Life Care During Critical ...

A comparison of hospitalized patients with heart failure and cancer referred to palliative care. JAMA Netw Open. 2020;3:e200020. doi ...

Tier - Palliative Care For Patients With Advanced Heart ...

Also called a data safety and monitoring ... Submission of false or misleading clinical trial information; Failure to submit primary and secondary outcomes.

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

Research has shown that palliative care can improve outcomes for patients with heart failure and advanced cancer by enhancing quality of life and better ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40884070/

Heart Failure Therapy in Patients with Advanced Cancer ...

Background and aims: Advanced cancer may resemble a heart failure (HF)-like phenotype marked by cardiac wasting, dyspnoea, congestion, and/or ...

Environmental Scan on Developing and Implementing ...

○ Condition-specific care (e.g., cancer care and mental health care). ... risk-standardized readmission and mortality rates for heart failure.

Multiprofessional heart failure self-development framework

We aimed to provide an expert consensus on the minimum heart failure-specific competencies necessary for multiple different healthcare professionals.