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.
The study aims are: * To evaluate the feasibility of enrolling patients into a study of TIER-PC; and * To provide data on subject retention, randomization success, intervention fidelity and estimates of the efficacy of the TIER-PC intervention in improving patients' symptoms and quality of life, and reducing emergency department visits and hospitalizations. This study will enroll 60 subjects with advanced non-colorectal gastrointestinal or lung cancer or advanced HF, 30 of which will be randomized to receive the study intervention and 30 of which will be randomized to receive usual care. The expected study duration is 18 months from enrollment initiation to completion of data analysis consisting of a 52- week active enrollment period, a 3 month follow up period, and a three month data analysis period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
60
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.
Mount Sinai Hospital
New York, New York, United States
The proportion of screened eligible patients
The proportion of screened eligible patients that are enrolled in the trial.
Time frame: 3 months
The proportion of patients completing the final 3-month visit
The proportion of the patients completing the final 3-month visit among all enrolled patients.
Time frame: 3 months
Number of TIER-PC intervention visits received per patient per month
The fidelity to intervention is defined as the number of TIER-PC intervention visits received per patient per month in the TIER-PC arm during the follow-up period.
Time frame: 3 months
Edmonton Symptom Assessment Scale (ESAS)
Patient symptoms will be measured (e.g., pain, shortness of breath) using the 9-item Edmonton Symptom Assessment Scale (ESAS) validated for serious illness. Each item is 10-point scale, total score ranges 0 (no symptoms) - 90 (worst severity), with higher scores indicating worse symptom severity.
Time frame: 3 months
Quality of Life measured using Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)
Quality of life (QoL) using the 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 from 0 (not at all) - 4 (very much). Total score ranges 0-184, with higher scores indicating better quality of life.
Time frame: 3 months
Number of participant emergency department (ED) visits
Number of participant ED visits
Time frame: 3 months
Number of participant hospitalizations
Number of participant hospitalizations
Time frame: 3 months
Number of participant hospital days
Number of participant hospital days
Time frame: 3 months
Patient-Reported Goals of Care Discussion (GOCD)
Patient report of goals of care discussions. Single item on GOCD with clinician. Response: Yes/No
Time frame: 3 months
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