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| ID | Type | Description | Link |
|---|---|---|---|
| 1R56NR020624-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual care | No Intervention | Patients will be cared for by the physician who treats their serious illness (cardiologist, oncologist, primary treating clinician) and other illnesses. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of screened eligible patients | The proportion of screened eligible patients that are enrolled in the trial. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Number of TIER-PC intervention visits received per patient per month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura P Gelfman, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
For individual participant data meta-analysis. Proposals should be directed to Arushi.Arora@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, to be determined.
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Before each research interview, subjects will be reminded not to tell the research coordinator to which study group they were assigned. In case of inadvertent unblinding of a blinded study team member, this team member will have to report the unblinding event to the PI. The study team member will not be allowed to collect data for the subjects whose group allocation they have inadvertently been unblinded to. A different, fully blinded study team member has to collect data for the respective subjects henceforth.
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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.
| 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. | 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. | 3 months |
| Number of participant emergency department (ED) visits | Number of participant ED visits | 3 months |
| Number of participant hospitalizations | Number of participant hospitalizations | 3 months |
| Number of participant hospital days | Number of participant hospital days | 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 | 3 months |