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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The proportion of screened eligible patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single blind control
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) with one hospitalization within the last 6 months
- •KPS > 50% (ECOG 0, 1 or 2)
- •> 2 outpatient MSHS visits in prior 12 months
- •Manhattan residence
- •Capacity to provide informed consent
- •English or Spanish fluency
- •> 18 years of age
排除标准
- •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
研究组 & 干预措施
Tier-Palliative Care
Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
干预措施: Tier-Palliative Care (Behavioral)
Usual Care
Patients will be cared for by the physician who treats their serious illness (cardiologist, oncologist, primary treating clinician) and other illnesses.
结局指标
主要结局
The proportion of screened eligible patients
时间窗: 3 months
The proportion of screened eligible patients that are enrolled in the trial.
次要结局
- Patient-Reported Goals of Care Discussion (GOCD)(3 months)
- Quality of Life measured using Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-Pal)(3 months)
- Edmonton Symptom Assessment Scale (ESAS)(3 months)
- The proportion of patients completing the final 3-month visit(3 months)
- Number of TIER-PC intervention visits received per patient per month(3 months)
- Number of participant hospitalizations(3 months)
- Number of participant hospital days(3 months)
- Number of participant emergency department (ED) visits(3 months)
研究者
Laura Gelfman
Professor
Icahn School of Medicine at Mount Sinai