Lay Health Worker Engage, Educate, and Encourage Patients to Share

Cancer Clinical Trial

— LEAPS  

Official title:

Lay Health Worker Engage, Educate, and Encourage Patients to Share

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699748
• Other study ID #: 40447
• Secondary ID: K23MD013474-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Death
• End of Life

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey	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 (FACT-G), a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.	Change in Quality of Life from Baseline to 4 Months
Secondary	Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey	The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 4 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. "I am satisfied that I am adequately informed about the issues important to my decision") on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group were averaged at 4 months after study enrollment. Results are expressed as a proportion of participants who responded "strongly agree" at 4 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded "strongly agree" are reflected from baseline to 4 months post-enrollment.	Proportion of patients who strongly agree that decisions about their health care were theirs to make at 4 months post study enrollment.
Secondary	Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey	The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 12 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. "I am satisfied that I am adequately informed about the issues important to my decision") on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group are averaged at 12 months after study enrollment. Results are expressed as a proportion of participants who responded "strongly agree" at 12 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded "strongly agree" are reflected from baseline to 12 months.	Proportion of patients who strongly agree that decisions about their health care were theirs to make at 12 months post study enrollment.
Secondary	Patient Activation Using the Patient Activation Measure Survey	Each patient will receive the 13-item Patient Activation Measure (PAM-13) at 4 months after study enrollment. This is a validated measure from Insignia Health. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. For the PAM-13, minimum score is 0 and maximum is 100. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining Behaviors and Pushing Further. Scores for each group will be averaged at 4 months after study enrollment.	Change in Patient Activation Measure from baseline to 4 months post enrollment.
Secondary	Patient Activation Using the Patient Activation Measure Survey	Each patient will receive the 13-item Patient Activation Measure (PAM-13) at 12 months after study enrollment. This is a validated measure from Insignia Health. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. For the PAM-13, minimum score is 0 and maximum is 100 (highest level of activation). Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining Behaviors and Pushing Further. Scores for each group will be averaged 12 months after study enrollment.	Change in Patient Activation Measure from baseline to 12 months post-enrollment.
Secondary	Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey	Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at 12 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General Survey-General survey. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.	Health-related quality of life at 12 months
Secondary	Emergency Department Visit (Chart Review)	Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Secondary	Emergency Department Visit (Chart Review)	Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Secondary	Emergency Department Visit (Chart Review)	Emergency Department Use will be abstracted by electronic medical record chart review for each patient who is deceased within 12 months of enrollment, looking at their ER visits during the last 30 days of life.	Last 30 days of life up to 12 months from patient enrollment
Secondary	Hospitalization Visit (Chart Review)	Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Secondary	Hospitalization Visits (Chart Review)	Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after study enrollment
Secondary	Hospitalization Visits (Chart Review)	Hospitalization use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their hospital visits during the last 30 days of life.	last 30 days of life
Secondary	Advance Directive Documentation (Chart Review)	Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Secondary	Advance Directive Documentation (Chart Review)	Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Secondary	Physician Orders for Life Sustaining Treatment (Chart Review)	Physician Orders for Life Sustaining Treatment (POLST) documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Secondary	Physician Orders for Life Sustaining Treatment (Chart Review)	Physician Orders for Life Sustaining Treatment (POLST) documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Secondary	Goals of Care Documentation (Chart Review)	Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Secondary	Goals of Care Documentation (Chart Review)	Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Secondary	Total Costs of Care	Total Costs of Care will be evaluated by review of claims data from time of enrollment until 12 months post-enrollment	12 months after patient enrollment
Secondary	Total Costs of Care End of Life	Total Costs of Care during the last 30 days of life will be evaluated by review of claims data from the 30 days preceding death for those patients who become deceased within 12 months of study enrollment.	Last 30 days of life up to 12 months from patient enrollment
Secondary	Palliative Care Use (Chart Review)	Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Secondary	Palliative Care Use (Chart Review)	Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Secondary	Palliative Care Use (Chart Review)	Palliative Care Use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their palliative care usage during the last 30 days of life.	last 30 days of life
Secondary	Hospice Use (Chart Review)	Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.	4 months after patient enrollment
Secondary	Hospice Use (Chart Review)	Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.	12 months after patient enrollment
Secondary	Hospice Use (Chart Review)	Hospice Use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their hospice use during the last 30 days of life.	last 30 days of life
Secondary	Survival (Chart Review)	Survival rate for patients will be abstracted by electronic medical record chart review at 4 months after enrollment.	4 months after patient enrollment
Secondary	Survival (Chart Review)	Survival rate for patients will be abstracted by electronic medical record chart review at 12 months after enrollment.	12 months after patient enrollment
Secondary	Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey	The validated Satisfaction with Decision (SWD) Survey was administered to all participants at baseline. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. "I am satisfied that I am adequately informed about the issues important to my decision") on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Results are expressed as a proportion of participants who responded "strongly agree" at Baseline on the Satisfaction with Decision scale, which measured ratings of decision-making.	Proportion of patients who strongly agreed the decisions about their health care were theirs to make at baseline (study enrollment).