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

Study Overview
=================
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.

Official Title
-----------------
Lay Health Worker Engage, Educate, and Encourage Patients to Share

Conditions
-----------------
End of Life, Cancer

Intervention / Treatment
-----------------
* Behavioral: Lay Health Worker Intervention
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed patients with a cancer diagnosis. Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician. The patients must be 18 years or older. 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. Patients not eligible for Fund benefits. Patients without a newly diagnosed malignancy or patients without relapse of disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group Arm<br>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<br>* 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.<br>Other: Usual Care<br>* Usual care as provided by Unite Here Health and local oncologists<br>|
| Active Comparator: Control Group Arm<br>The control group arm will receive usual care as provided by Unite Here Health and their local oncologists. | Other: Usual Care<br>* Usual care as provided by Unite Here Health and local oncologists<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, end of life, patient-centered