Lay Health Worker Engage, Educate, and Encourage Patients to Share (LEAPS)

Stanford University

Status: Completed

Conditions: Cancer; End of Life

Treatments: Behavioral: Lay Health Worker Intervention; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03699748

K23MD013474-01 (U.S. NIH Grant/Contract)

40447

Details and patient eligibility

About

The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.

Full description

Unite Here Health proposes to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their members. The Lay Health Worker Engages, Educates, and Encourages Patients to Share intervention is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Unite Here Health members who are diagnosed with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals. The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation and quality of life outcomes, and that the program helps to reduce utilization of health care resources at the end of life.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Newly diagnosed patients with a cancer diagnosis.
2. Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
3. The patients must be 18 years or older.
4. Patients must have the capacity to verbally consent.

Exclusion criteria

1. Inability to consent to the study due to lack of capacity as documented by the referring physician.
2. Patients without a newly diagnosed malignancy or patients without relapse of disease.
3. Patients not eligible for Fund benefits.

Patients without a newly diagnosed malignancy or patients without relapse of disease.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Intervention Group Arm

Experimental group

Description:

Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention arm will also receive usual care as provided by Unite Here Health and their local oncologists.

Treatment:

Other: Usual Care

Behavioral: Lay Health Worker Intervention

Control Group Arm

Active Comparator group

Description:

The control group arm will receive usual care as provided by Unite Here Health and their local oncologists.

Treatment:

Other: Usual Care