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

• ClinicalTrials.gov Identifier: NCT03699748
• Recruitment Status: Recruiting
• First Posted: October 8, 2018
• Last Update Posted: October 1, 2019
• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH); National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Manali Indravadan Patel, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
End of Life; Cancer	Behavioral: Lay Health Worker Intervention; Other: Usual Care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Lay Health Worker Engage, Educate, and Encourage Patients to Share
• Actual Study Start Date: October 3, 2018
• Estimated Primary Completion Date: October 3, 2021
• Estimated Study Completion Date: October 3, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Group Arm; 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.	Behavioral: Lay Health Worker Intervention; 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 is provided along with usual care as provided by Unite Here Health and local oncologists.; Other: Usual Care; Usual care as provided by Unite Here Health and local oncologists
Active Comparator: Control Group Arm; The control group arm will receive usual care as provided by Unite Here Health and their local oncologists.	Other: Usual Care; Usual care as provided by Unite Here Health and local oncologists

Outcome Measures

Primary Outcome Measures :

1. Change in Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey [ Time Frame: Change in Quality of Life from baseline to 6 months. ] [ Time Frame: 4 months after patient enrollment ]
   Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at baseline and 4 months. We will measure the change in quality of life at baseline to 4 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General Survey-General survey.

Secondary Outcome Measures :

1. Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey [ Time Frame: 4 months after patient enrollment ]
   Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 4 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 4 months after study enrollment.
2. Patient activation using the Patient Activation Measure survey [ Time Frame: 4 months after patient enrollment ]
   Each patient will receive a validated patient activation survey using the Patient Activation Measure at 4 months after study enrollment. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Scores for each group will be averaged at 4 months after study enrollment.
3. Patient activation using the Patient Activation Measure survey [ Time Frame: 12 months after study enrollment ]
   Each patient will receive a validated patient activation survey using the Patient Activation Measure at 12 months after study enrollment. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Scores for each group will be averaged 12 months after study enrollment.
4. Emergency Department Visit (Chart Review) [ Time Frame: 4 months after patient enrollment ]
   Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
5. Emergency Department Visit (Chart Review) [ Time Frame: 12 months after patient enrollment ]
   Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
6. Hospitalization Visit (Chart Review) [ Time Frame: 4 months after patient enrollment ]
   Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
7. Hospitalization Visits (Chart Review) [ Time Frame: 12 months after study enrollment ]
   Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
8. Advance Directive Documentation (Chart Review) [ Time Frame: 4 months after patient enrollment ]
   Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
9. Advance Directive Documentation (Chart Review) [ Time Frame: 12 months after patient enrollment ]
   Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
10. Goals of Care Documentation (Chart Review) [ Time Frame: 4 months after patient enrollment ]
    Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
11. Goals of Care Documentation (Chart Review) [ Time Frame: 12 months after patient enrollment ]
    Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Inability to consent to the study due to lack of capacity as documented by the referring physician.

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

Contacts and Locations

Contacts

Contact: Manali I Patel, MD MPH MS; 650-723-4000; manalip@stanford.edu

Locations

United States, California

Stanford University School of Medicine; Recruiting

Stanford, California, United States, 94305

Contact: Manali I Patel, MD MPH MS

Principal Investigator: Manali I Patel, MD MPH MS

Sponsors and Collaborators

Stanford University

National Institutes of Health (NIH)

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: Manali I Patel, MD MPH MS; Stanford University

More Information

• Responsible Party: Manali Indravadan Patel, Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03699748 History of Changes
• Other Study ID Numbers: 40447; K23MD013474-01 ( U.S. NIH Grant/Contract )
• First Posted: October 8, 2018
• Last Update Posted: October 1, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manali Indravadan Patel, Stanford University:

cancer; end of life; patient-centered