Clinical trial NCT03699748: Lay Health Worker Engage, Educate, and Encourage Patients to Share
Official title: Lay Health Worker Engage, Educate, and Encourage Patients to Share
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life
Cancer
Keywords: cancer
end of life
patient-centered
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-10-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
timeFrame: Change in Quality of Life from Baseline to 4 Months
Secondary outcomes:
measure: Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey
timeFrame: Proportion of patients who strongly agree that decisions about their health care were theirs to make at 4 months post study enrollment.
measure: Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
timeFrame: Proportion of patients who strongly agree that decisions about their health care were theirs to make at 12 months post study enrollment.
measure: Patient Activation Using the Patient Activation Measure Survey
timeFrame: Change in Patient Activation Measure from baseline to 4 months post enrollment.
measure: Patient Activation Using the Patient Activation Measure Survey
timeFrame: Change in Patient Activation Measure from baseline to 12 months post-enrollment.
measure: Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
timeFrame: Health-related quality of life at 12 months
measure: Emergency Department Visit (Chart Review)
timeFrame: 4 months after patient enrollment
measure: Emergency Department Visit (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Emergency Department Visit (Chart Review)
timeFrame: Last 30 days of life up to 12 months from patient enrollment
measure: Hospitalization Visit (Chart Review)
timeFrame: 4 months after patient enrollment
measure: Hospitalization Visits (Chart Review)
timeFrame: 12 months after study enrollment
measure: Hospitalization Visits (Chart Review)
timeFrame: last 30 days of life
measure: Advance Directive Documentation (Chart Review)
timeFrame: 4 months after patient enrollment
measure: Advance Directive Documentation (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Physician Orders for Life Sustaining Treatment (Chart Review)
timeFrame: 4 months after patient enrollment
measure: Physician Orders for Life Sustaining Treatment (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Goals of Care Documentation (Chart Review)
timeFrame: 4 months after patient enrollment
measure: Goals of Care Documentation (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Total Costs of Care
timeFrame: 12 months after patient enrollment
measure: Total Costs of Care End of Life
timeFrame: Last 30 days of life up to 12 months from patient enrollment
measure: Palliative Care Use (Chart Review)
timeFrame: 4 months after patient enrollment
measure: Palliative Care Use (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Palliative Care Use (Chart Review)
timeFrame: last 30 days of life
measure: Hospice Use (Chart Review)
timeFrame: 4 months after patient enrollment
measure: Hospice Use (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Hospice Use (Chart Review)
timeFrame: last 30 days of life
measure: Survival (Chart Review)
timeFrame: 4 months after patient enrollment
measure: Survival (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
timeFrame: Proportion of patients who strongly agreed the decisions about their health care were theirs to make at baseline (study enrollment).
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Manali I Patel, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel MI, Khateeb S, Coker T. A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings. Contemp Clin Trials. 2020 Apr;91:105971. doi: 10.1016/j.cct.2020.105971. Epub 2020 Mar 4.