Recruiting at 5 sites No phase Advanced Heart Failure

Advanced Heart Failure study: Tier-Palliative Care vs Community Health Worker

Official title Tier Palliative Care For Patients With Advanced Heart Failure or Cancer

ClinicalTrials.gov ID: NCT07391956

What this study is testing

What it's testing
The study wants to see if matching the level of home‑based palliative support to a patient’s symptoms and abilities improves their comfort and care.
Who it's for
Adults who have advanced heart failure or advanced non‑colorectal gastrointestinal, lung, or triple‑negative breast cancer.
What's involved
Participants get a community health worker who visits at home and talks about their illness. As symptoms get worse, a social worker, then a nurse, and finally a doctor may join the team to help manage symptoms and discuss care goals.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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) or tripe negative breast cancer...
  • KPS \> or = 50% (ECOG 0, 1 or 2)
  • \> 2 outpatient MSHS visits in prior 12 months
  • Manhattan or Queens residence

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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) or tripe negative breast cancer with one hospitalization within the last 6 months
  • KPS \> or = 50% (ECOG 0, 1 or 2)
  • \> 2 outpatient MSHS visits in prior 12 months
  • Manhattan or Queens residence
  • Capacity to provide informed consent
  • English or Spanish fluency
  • \> or = 18 years of age
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it is enrolling

  • Astoria, New York, United States
  • New York, New York, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Astoria, New York, United States; New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.