Advanced Heart FailureTIER-PCNCT07391956
Tier Palliative Care For Patients With Advanced Heart Failure or Cancer
A study testing Tier-Palliative Care and Community Health Worker in people with Advanced Heart Failure and Advanced Non-Colorectal Gastrointestinal Cancer, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Heart Failure, Advanced Non-Colorectal Gastrointestinal Cancer, Advanced Lung Cancer
- What is being tested?
- Tier-Palliative Care and Community Health Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Jul 2026to 31 Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Mount Sinai Queens
Astoria, New York, 11102
- Recruiting
Mount Sinai Downtown
New York, New York, 10003
- Recruiting
Mount Sinai West
New York, New York, 10019
Laura Gelfman, MD, MPH, Laura.Gelfman@mssm.edu
- Recruiting
Mount Sinai Morningside
New York, New York, 10025
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Laura Gelfman, MD, MPH, Laura.Gelfman@mssm.edu
About this study
Official title: TIER-PALLIATIVE CARE: A Population-based Care Delivery Model to Match Evolving Patient Needs and Palliative Care Services for Community-based Patients With Heart Failure or Cancer
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.
Read the detailed description
The objective of this randomized controlled trial is to study the impact of a novel home based palliative care intervention on patients' symptoms, quality of life, and completion of goals of care documentation. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver anxiety, satisfaction with care and post-traumatic symptoms. Patients randomized to the intervention will be scheduled for Tier-PC visit community health work to allocate to Tier-PC tier. Visits will combine a combination of video-teleconferencing technology and in person visits. Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.
- Conditions
- Advanced Heart Failure, Advanced Non-Colorectal Gastrointestinal Cancer, Advanced Lung Cancer, Advanced Triple Negative Breast Cancer
- Being tested
- Tier-Palliative Care, Community Health Worker
- Keywords
- palliative care, community-based, advanced heart failure, advanced cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tier-Palliative CareBehavioural
Also called Tier-PC
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. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines.
Community Health WorkerBehavioural
Usual Care plus the addition of a community health worker who will serve as a health coach for the participant.
| Study group | Role | What they receive |
|---|---|---|
| Tier-Palliative Care | Experimental | Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician based on symptom burden and function. Receives: Behavioral: Tier-Palliative Care |
| Augmented Control | Active comparator | Visits to the patient from a CHW without training in heart failure, cancer or palliative care. Receives: Behavioral: Community Health Worker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Symptom Assessment Scale (ESAS)
Patient symptoms: Edmonton Symptom Assessment Scale (ESAS), 9 items, each item is scored on a 10-point scale, total score ranges from 0-90, higher scores indicate more symptoms.
Measured: 12 months
Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)
Patient quality of life: 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. Total score ranges from 0-184, higher scores indicate better quality of life
Measured: 12 months
Patient-reported goals of care discussion
Patient-reported Goals of Care Discussions: "Have you ever discussed with this doctor the kind of medical care you would want if you were too sick to speak for yourself?" Response: Yes/No
Measured: 12 months
Secondary outcomes (5)
Generalized Anxiety Disorder-7 (GAD-7)
Generalized Anxiety Disorder-7 (GAD-7), a 7-item scale, Full scale from 0-21, higher scores indicates more anxiety.
Measured: 12 months
Family Satisfaction with End-of-Life Care (FAMCARE-10)
FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. Full scale ranges 0-20, with higher scores indicating higher satisfaction.
Measured: 12 months
Number of hospital admissions
Number of hospital admissions: Acute care utilization as measured by the number of hospital admissions
Measured: 12 months
Number of hospital days
Number of hospital days: Acute care utilization as measured by the number of hospital days
Measured: 12 months
Number of emergency department (ED) visits
Number of emergency department (ED) visits: Acute care utilization as measured by the number of ED visits
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start10 Jul 2026
- Primary completion30 Nov 2030 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Laura Gelfman, Icahn School of Medicine at Mount Sinai
- Investigators
- Laura Gelfman, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391956
- Sponsor's protocol ID
- STUDY-22-00591 R01
- Acronym
- TIER-PC
- Status last verified
- Jul 2026
- First submitted
- 27 Jan 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIER-PALLIATIVE CARE: A Population-based Care Delivery Model to Match Evolving Patient Needs and Palliative Care Services for Community-based Patients With Heart Failure or Cancer
- ClinicalTrials.gov ID
- NCT07391956
- Acronym / sponsor ID
- TIER-PC / STUDY-22-00591 R01
- Conditions
- Advanced Heart Failure, Advanced Non-Colorectal Gastrointestinal Cancer, Advanced Lung Cancer, Advanced Triple Negative Breast Cancer
- Keywords
- palliative care, community-based, advanced heart failure, advanced cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this randomized controlled trial is to study the impact of a novel home based palliative care intervention on patients' symptoms, quality of life, and completion of goals of care documentation. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver anxiety, satisfaction with care and post-traumatic symptoms. Patients randomized to the intervention will be scheduled for Tier-PC visit community health work to allocate to Tier-PC tier. Visits will combine a combination of video-teleconferencing technology and in person visits. Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tier-Palliative Care | Experimental | Behavioral: Tier-Palliative CarePatients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician based on symptom burden and function. |
| Augmented Control | Active comparator | Behavioral: Community Health WorkerVisits to the patient from a CHW without training in heart failure, cancer or palliative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tier-Palliative CareAlso: Tier-PCTIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines. | Behavioural | Tier-Palliative Care |
| Community Health WorkerUsual Care plus the addition of a community health worker who will serve as a health coach for the participant. | Behavioural | Augmented Control |
Primary outcome
Edmonton Symptom Assessment Scale (ESAS)
Time frame: 12 months
Patient symptoms: Edmonton Symptom Assessment Scale (ESAS), 9 items, each item is scored on a 10-point scale, total score ranges from 0-90, higher scores indicate more symptoms.
Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)
Time frame: 12 months
Patient quality of life: 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. Total score ranges from 0-184, higher scores indicate better quality of life
Patient-reported goals of care discussion
Time frame: 12 months
Patient-reported Goals of Care Discussions: "Have you ever discussed with this doctor the kind of medical care you would want if you were too sick to speak for yourself?" Response: Yes/No
5 secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 12 months
Family Satisfaction with End-of-Life Care (FAMCARE-10)
Time frame: 12 months
Number of hospital admissions
Time frame: 12 months
Number of hospital days
Time frame: 12 months
Number of emergency department (ED) visits
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Advanced Heart Failure
Not yet recruiting
Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies
Heart Failure, Heart Failure New York Heart Association Class III
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TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
Advanced Heart Failure, Heart Transplantation
Not yet recruiting
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
Congenital Heart Disease, Advanced Heart Failure
Recruiting
Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer
Advanced Heart Failure, Advanced Non-Colorectal Gastointestinal Cancer
Not yet recruiting
TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease
Advanced Heart Failure, Acquired Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Gelfman principal investigator
Icahn School of Medicine at Mount Sinai
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tier-Palliative Care and Community Health Worker in people with Advanced Heart Failure and Advanced Non-Colorectal Gastrointestinal Cancer, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Espino (212-421-4632, Christian.Espino@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edmonton Symptom Assessment Scale (ESAS) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.