Tier Palliative Care For Patients With Advanced Heart Failure or Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tier-Palliative Care

    Behavioral

    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 Worker

    Behavioral

    Usual Care plus the addition of a community health worker who will serve as a health coach for the participant.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Tier-Palliative CareExperimental treatment 1 intervention
Group B: Augmented ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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

Time frame
12 months
3

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

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

Number of hospital admissions

Number of hospital admissions: Acute care utilization as measured by the number of hospital admissions

Time frame
12 months
4

Number of hospital days

Number of hospital days: Acute care utilization as measured by the number of hospital days

Time frame
12 months

Other outcomes

Sponsors and contacts

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Icahn School of Medicine at Mount Sinai

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator