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New adaptive palliative care model aims to give right care at the right time

NCT ID NCT06228209

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study tests a home-based palliative care program called TIER-PC that adjusts the care team based on a patient's symptoms and ability to function. It includes 60 adults with advanced heart failure or certain cancers living in Manhattan. The program adds more specialists—like social workers or nurses—as needs increase, with a community health worker staying involved throughout.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tier - Palliative Care (TIER-PC) behavioral intervention
What this could lead to
If successful, this model could improve quality of life and symptom management for people with advanced heart failure or cancer by matching care intensity to their changing needs.
What could go wrong
This is a small, early feasibility study with only 60 participants, so results may not apply to everyone. The main goal is to see if the model can be delivered, not yet to prove it improves outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

advanced heart failure digestive system cancer digestive system carcinoma lung cancer lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced heart failure Advanced lung cancer Advanced non-colorectal gastointestinal cancer Advanced non-colorectal gastro-intestinal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

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