This clinical trial tests how well a new population-based care delivery model to match evolving patient needs to palliative care services for community-based (TIER-palliative care) works in patients living with heart failure (HF) or cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palliative care aims to support people living with serious illnesses and improve their quality of life. The new palliative care model being tested is designed to provide the right level of care to the right patients at the right time. It consists of a community health worker, who checks in with the patient on a regular basis. Depending on the patient’s needs, the community health worker will add more members to the team (social worker, nurse practitioner, physician). Team members will help by treating physical symptoms, providing emotional support, explaining more about the illness and what to expect in the future, and discussing what is important to patients to inform future decision making. This new palliative care intervention may improve symptoms and the quality of life of patients with advanced heart failure and advanced cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06228209.
Locations matching your search criteria
United States
New York
Astoria
Mount Sinai QueensStatus: Active
Contact: Laura Gelfman
New York
Mount Sinai Saint Luke'sStatus: Active
Contact: Laura Gelfman
Mount Sinai ChelseaStatus: Active
Contact: Laura Gelfman
Icahn School of Medicine at Mount SinaiStatus: Active
Contact: Laura Gelfman
Phone: 212-241-4323
Mount Sinai WestStatus: Active
Contact: Laura Gelfman
Phone: 212-241-4323
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of enrolling patients into a study of TIER-PC.
SECONDARY OBJECTIVES:
I. 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, increasing the completion of goals of care discussions, and reducing acute care utilization and healthcare cost.
II. To provide data on caregiver satisfaction and caregiver anxiety.
OUTLINE: Patient caregiver dyads are randomized to 1 of 2 arms.
ARM I: Dyads meet with a community health worker at least every other week over 20 minutes by phone or in person to discuss symptoms and needs over 3 months. Depending on the dyads needs and symptoms, dyads receive tiered care. Dyads receive palliative care with education on the patient’s medical conditions while assisting patients with access to healthcare and social services from the community health worker (CHW) in tier 1. Dyads receive tier 1 care in addition to social worker (SW) support to get more community support, e.g., home care, and learn about values to help get the medical care wanted in the future in tier 2. Dyads receive tier 1 and 2 care in addition to support from an advanced practice nurse (APN) to help manage complex symptoms, including prescribing medications; supplement the work of the CHW and SW regarding illness and prognosis understanding; and provide treatment recommendations based on aligning the treatment options and the patient’s goals and values. Dyads receive tier 1-3 care in addition to support from a doctor to help manage multifaceted symptoms by titrating medications in the face of deteriorating organ function in tier 4. Dyads may be re-allocated to different tiers throughout the trial dependent on their needs.
ARM II: Dyads receive usual care.
After completion of study intervention, patients are followed up at 1, 2, and 3 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorLaura Gelfman
