Infections

Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Hepatitis A

Hepatitis

Hepatitis B

Liver Neoplasms

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Virus Diseases

Communicable Diseases

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Gastrointestinal Neoplasms

Digestive System Neoplasms

All Drugs and Chemicals

Hematinics

Vaccines

Liver Extracts

LHWs conducted phone interventions by reminding participants of a series of vaccinations at months 1, 2, and 5 among those assigned to the intervention group. Those who had health insurance were encouraged to complete vaccinations through their providers. If participants did not have health insurance, LHWs provided resources to help those in the intervention access vaccinations by referring them to free vaccine events in the community.

Those in the control group received a list of resources along with their results by mail that offered free vaccinations, such as local health departments.

Lay Health Worker Phone Intervention The second phase addressed phone intervention training, where LHWs who had completed the first phase and were willing to participate in the second phase learned the process for calling participants to remind them to complete a series of HBV vaccinations. The LHWs assigned to the intervention group conducted phone interventions by reminding participants about completing a series of vaccinations at Months 1, 2, and 6, and also provided accompanying resources and support.

Lay Health Worker Intervention

Placebo (a list of resources)

Hee-Soon Juon, PhD

The study was conducted between April 2013 and October 2014. In the parent study, 600 foreign-born Asian American adults 18 years of age and older were drawn from the community in the Baltimore Washington Metropolitan Area. Using a non-probability sampling method, foreign-born Asian American adults, 18 years of age and older, were recruited from the community.

After providing informed consent, all the participants were asked to complete a self-administered questionnaire in English, Chinese, Korean, or Vietnamese with the assistance of a bilingual interviewer when necessary. Then, all of the participants were instructed and given 5 to 10 to minutes to read culturally integrated and linguistically appropriate educational material (e.g., Photo novel) developed and validated for efficacy from a prior study.

All participants received hepatitis B testing: HBsAg (hepatitis B surface antigen), HBsAb (hepatitis B surface antibody) and, HBcAb (hepatitis B core antibody). A total of 600 completed the survey and screening. A week later, they received the results of the screening test. Based on the screening results, all participants were categorized into three groups: (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), or (3) protected (HbsAg-/HbsAb+). We sent the results by mail to participants who were unprotected and protected. Among those 600 screened participants, 33(5.5%) had chronic hepatitis B virus (HBV) infection and 335 (55.8%) had evidence of resolved HBV infection (protected). A total of 232 (38.7%) were susceptible to HBV infection (unprotected).

LHW (lay health worker) Intervention for those unprotected: Those unprotected (n=232) were randomly assigned to either the intervention (n=124) or the control (n=108) groups by computer-automated random assignment. Randomization was used to assure equivalence between groups on key factors that may potentially influence the outcome of HBV vaccinations: gender, age, education, length of stay in the U.S.

LHWs conducted phone interventions by reminding participants of a series of vaccinations at months 1, 2, and 5 among those assigned to the intervention group. Those in the control group received a list of resources along with their results by mail that offered free vaccinations, such as local health departments. Seven months after mailing the results, those unprotected were followed up by phone to ask about their status of the series of vaccinations and about promoters or barriers to vaccinations.

Specific Aim 1. Develop a training protocol and certification program for lay health workers (LHWs)

People of Asian backgrounds are likely to exhibit cultural relativism leaning toward collectivism compared to individualism. The personal interactions within their self-identified cultural communities may closely relate to development of their perceived beliefs and subjective norms, which influence to act upon identified health behaviors (Ajzen, Albarracin \& Hornik 2007). The investigators will develop a lay health worker (LHW) model that highlights the effects of culturally competent human and educational interactions on facilitating the Chinese-, Korean- and Vietnamese-American (CKV-A) community's active behaviors in hepatitis B screening, vaccination, and treatments. To develop an efficacious and effective LHW intervention that will contribute for creating a critical mass toward sustainable Chinese, Korean and Vietnamese (CKV) changes, our strategic approaches include as follows:

1. Review the liver cancer education program guidebook in English, (developed by previous project R25).
2. Refine/revise the approaches through work group reviews: Through a series of bi-monthly meetings with participants from community advisory board (CAB), CKV-A communities, health practitioners and outreach workers, and experts in hepatitis B virus (HBV) and liver cancer education (Juon and Lee), and education and evaluation (Park), the investigators will confirm/specify the approaches of the available materials and develop additional assessment approaches and forms in English.
3. Test the validities of subgroup language versions with pilot CKV groups: Through assessments with each group (n=10) of CKV-As, the investigators will produce the refined validated LHW protocol (after translation and back-translation). It will include common and unique approaches across/within subgroup(s) to be congruent with cultural values.
4. Test the pilot LHW implementation
5. Establish the LHW model to certify satisfactory practicum experience in Patient Navigation training module: Through ongoing assessments with the study participants and participating health care systems, the investigators will monitor the LHW experiential learning module to provide patient navigation function. The approach will identify barriers to hinder access to timely screening, follow-up, and treatment upon diagnosis.

Recruitment: Earp et al. (1997) suggest effective LHWs would have some or all of the following characteristics and skills: (1) the ability to comfortably and effectively access the health care system; (2) the ability to balance the demands of lay helping with other life responsibilities; (3) an interest in AA's health and social issues; (4) maintain close, supportive, and reciprocal connections with others; and (5) leadership skills. LHW models depend on genuine natural helpers to function. To increase recruitment potential for CKVs having desired characteristics: First, the investigators will reach a broad pool of adult volunteers, regardless of gender, income level, or health care experience, who have these characteristics and also have the ability to speak, read and write Chinese, Korean, or Vietnamese languages at or above 2nd grade level. Second, adopting a referral recruitment strategy in social market theory (Lefebvre et al. 1988) as it may be more effective for people who may be more responsive to their sense of collective cultural group's interactions, the investigators will recruit the first 10 LHW candidates per each ethnic group referred by word of mouth, faith-based organization leaders, community advisory groups, and health and social service agencies. Finally, the investigators will expand our recruitment continuously in the community. In Year 1, the investigators plan to train a total of 60 certified LHWs (20 from each ethnic group). The investigators estimate retention of 40 (67%) certified LHWs at the end of the Year 1, based upon literature reviews (Anderson 2000; Caulfield et al. 1998; Han et al. 2009). To replace drop-out LHWs in subsequent years, the investigators plan to recruit and train a total of 30 additional LHWs (10 for each ethnic group) from Years 2 to 3.

Process Evaluation: Using evaluation model of Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) (Glasgow et al. 2001), a framework that emphasized on Reach, Effectiveness, Adoption, Implementation and Maintenance, the investigators will examine the extent to which the LHW program is carried out through processes as intended. At individual level, the investigators will focus on Reach (R) of the LHW certification program and hepatitis B free events and on the Efficacy/Effectiveness (E) of the LHW certification program. For the group level of aggregated individuals, the investigators will assess on Adoption (A), Implementation (I), and Maintenance (M). The investigators will assess general administrative processes of LHW program during the study period in the selected perspectives of fidelity (e.g. logistic reviews, completion rates), dose (e.g. satisfaction survey), and method on translated forms and tools (Saunders, Evans, \& Joshi 2005).

Specific Aim 2. To assess the prevalence of HBV infection by providing screening test

A total of 600 Asian American adults (200 Chinese, Koreans, and Vietnamese each), 18 years of age and older will be drawn from the community.

Recruitment strategy. The investigators have two major channels to recruit participants with the help of certified LHWs including hepatitis B initiative of Washington DC (HBI-DC) screening events and Asian American Health Center (AAHC). First, in the past 10 years, the HBI-DC has screened over 3000 individuals in the Baltimore-Washington Metropolitan Area and approximately 8 to 11% are positive for the surface antigen of the hepatitis B virus (HBsAg). Thus, many individuals are availing themselves of the free testing services. LHWs will announce upcoming screening events in their community by advertising in Korean churches or Chinese language schools or by word-of-mouth. Our research team and LHWs will attend these events to recruit potential participants. Based on previous experiences, each screening event attracted about 100 to 150 Asian Americans. Second, the investigators will go to AAHC volunteer clinics to recruit participants every Saturday. About 10 to 12 Chinese or Korean patients visit the clinic. Patients usually come with family members. So, the investigators estimate to recruit about 15 to 20 participants at the clinics every Saturday. Finally, the investigators will identify potential participants by advertising in ethnic media and ethnic groceries.

Sample size estimate: Based on our previous studies (Juon et al. 2008; Hsu et al. 2007), the investigators estimate that about 10% of all the participants will test hepatitis B virus (HBV) positive, 40 to 50% will be HBV negative but protected, and about 50% will be unprotected. In the preliminary analysis of R25, there were significant mean differences of knowledge of HBV transmission (score ranged 0-10) in intervention (7.21±1.83SD) and control group (5.54±2.07SD) in post-test. The investigators estimated our sample size to be 50 in each intervention and control group among those unprotected. Assuming a conservative rate of attrition about 20%, the investigators calculated the study power based on sample size at follow-up. The sample size of 50 at pre-test is to detect mean difference in knowledge outcome at 96% power (1-β) and type I error of 0.05.Thus, our proposed sample size (n=50) for each group among those unprotected has sufficient power. Our total sample size is 600 (50/group x 2 groups x 2 (infected and protected-50% of study population) x 3 ethnic groups).

Specific Aim 3. To implement LHW intervention among those unprotected Procedures

1. Pre-test/Education program: After obtaining the informed consent for pre-test, screening test, and blood banking, all the participants will be asked to complete a self-administered questionnaire in English, Chinese, Korean, or Vietnamese, with the assistance of a bilingual interviewer when necessary. Then, LHW will provide a liver cancer education session to all participants in a small group setting.
2. HBV screening test/initial biospecimen banking: All participants will receive hepatitis B testing. For blood sampling procedure, the investigators will have a part-time phlebotomist working in the field with a bilingual staff and LHW. The phlebotomist will draw two tubes of blood from study participants at the study site. He/she will then transport one tube of the blood in red-top tube to certified clinical labs (i.e., Johns Hopkins Medical Institute (JHMI), Quest, LabCorp) for hepatitis B tests (e.g., HBsAg, HBsAb (surface antibody of HBV), HBcAb (core antibody of HBV)). The other tube will be processed for research sample banking.
3. Informing the results of screening test: All the participants will receive the results one week after their screening. Based on the screening results, all participants will be categorized into three groups: (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), and (3) protected (HbsAg-/HbsAb+). The investigators will order all screening tests and review all test results from the certified clinical labs. The investigators will mail the results to participants who are unprotected and protected. The investigators will not follow up healthy participants who are protected. The investigators will be responsible for informing the results by calling those infected individuals. The participants will provide counseling on what the results mean and treatment options.
4. Follow up for those infected: Those infected can either be referred through their primary care physicians to a hepatologist or directly to a hepatologist. If participants do not have a hepatologist, participants will be referred to hepatologists in the study team. This will be based on their language preference and geographic location.
5. LHW Intervention/follow up for those unprotected: Those unprotected will be randomly assigned to either the intervention or the control groups by computer-automated random assignment. Randomization will be used to assure equivalence between groups on key factors that may potentially influence the primary outcome of HBV vaccinations (e.g., gender, age, education, length of stay in the U.S.).

LHWs will conduct telephone interventions by reminding participants of a series of vaccinations at Months 1, 2, and 6 among those assigned to the intervention group. Those who have health insurance will be encouraged to complete vaccinations through their providers. If participants do not have health insurance, LHWs will provide resources to help those in the intervention access vaccinations by referring them to the AAHC, or County Health Departments who provide vaccinations to at risk populations. Those in the control group will receive a list of resources by mail that offers free vaccinations, such as local health departments along with their results. Upon completing follow-up, the investigators will provide the delayed LHW intervention for those who do not have vaccinations in the control group.

Seven months after mailing the results, those unprotected will be followed by phone to ask about their status of the series of vaccinations and promoters or barriers to vaccinations. Their self-reported vaccination will be verified with medical records. Participants will be asked to provide information about the date of vaccinations, as well as the location of the clinic or doctor's office where participants received vaccinations. Participants will also be asked to sign a medical release form giving project staff permission to request medical records for their vaccinations. The bilingual interviewers are blinded about participants being in the intervention or control group at post-test.

Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans

Seven months after mailing the results, those unprotected were followed up by phone to ask about their status of the series of vaccinations and about promoters or barriers to vaccinations. Their self-reported vaccinations were verified with the medical records. Participants were asked to provide information about the date of vaccinations as well as the location of the clinic or doctor's office where participants received vaccinations. Participants were also asked to sign a medical release form giving project staff permission to request medical records regarding their vaccinations. Each participant was given a stamped vaccination card to fill out the date and provide the signature of their physician following each completed hepatitis B vaccination. Participants were asked to mail the card back to the research team once the card was completed.

National Cancer Institute (NCI)

Thomas Jefferson University

Death

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.

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

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.

Usual care as provided by Unite Here Health and local oncologists

Usual Care

Manali I Patel, MD MPH MS

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.

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.

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

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.

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.

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.

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.

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.

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.

Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

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.

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

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.

Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

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.

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.

Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after 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.

Total Costs of Care will be evaluated by review of claims data from time of enrollment until 12 months post-enrollment

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.

Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

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.

Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

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.

Survival rate for patients will be abstracted by electronic medical record chart review at 4 months after enrollment.

Survival rate for patients will be abstracted by electronic medical record chart review at 12 months after enrollment.

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.

National Institutes of Health (NIH)

National Institute on Minority Health and Health Disparities (NIMHD)

Stanford University

Assistant Professor

The control group arm participants receive usual care.

Usual Care Control Group

Patients randomized into the intervention are assigned a lay health worker who will contact the patient to begin the intervention, and also receive usual care.

Lay Health Worker Intervention Group

Total

Age, Continuous

Male

Female

Non-binary

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

< $25,000

≥ $25,000 to $34,999.00

≥ $35,000 to $49,999.00

Annual household income

Atlantic City, NJ

Chicago, IL

City

Less than high school

High school

2-year college or Bachelor degree

Education Level

Breast

Gastrointestinal

Genitourinary

Lung

Ovarian

Malignant hematologic

Head and Neck

Other (skin, soft tissue, brain)

Anatomic site of cancer diagnosis

Dr. Manali Patel

Baseline

Month 4

Participants who completed the survey at each respective time point are included in the analysis.

Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey

At 4 Months, 74 (92.5%) in the control group and 71 (88.8%) in the intervention group completed this survey and 6 (7.5%) participants in the control group and 9 (11.3%) participants in the intervention group had died by the time of this assessment.

Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey

A total of 59 participants (73.8%) in the control group and 56 (70.0%) in the intervention group completed this survey question at 12-months post study enrollment; 21 (26.3%) participants in the control group and 23 (28.8%) participants in the intervention group had died at the time of the 12-month assessment.

Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey

Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person. The effect estimate column shows the difference between change in the intervention group from baseline and the change in the control group from baseline.

4 Months

Missingness was only observed due to death among 6 (7.5%) participants in the control group and 9 (11.3%) participants in the intervention group who had died prior to the 4-month assessment.

Patient Activation Using the Patient Activation Measure Survey

Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person.

Missingness was only observed due to death among 21 (26.3%) participants in the control group and 23 (28.8%) participants in the intervention group who had died prior to this 12-month assessment.

Participants who completed the survey at 12 months are included in the analysis.

Emergency Department Visit (Chart Review)

Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.

Odds Ratios for any ED Use were estimated using logistic regression models.

Sample of 21 participants in the control group and 23 participants in the intervention group who died within 12 months of study enrollment.

Hospitalization Visit (Chart Review)

Hospitalization Visits (Chart Review)

Odds Ratios for Hospitalization Use were estimated using logistic regression models.

sample of 21 participants in the control group and 23 participants in the intervention group who died within 12 months of study enrollment

Advance Directive Documentation (Chart Review)

Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months post-enrollment with logistic regression.

Physician Orders for Life Sustaining Treatment (Chart Review)

Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.

Goals of Care Documentation (Chart Review)

Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data after adjustment for length of follow-up.

Total Costs of Care

Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data.

sample of 21 participants in the control group and 23 participants in the intervention group who died within 12 months of study enrollment.

Total Costs of Care End of Life

Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.

Palliative Care Use (Chart Review)

Odds Ratios for any ED Use and any Palliative Care were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.

Hospice Use (Chart Review)

Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments at 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.

Odds Ratios for any ED Use and any Hospice Receipt were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.

Survival (Chart Review)

79 (98.8%) participants in the control group and 80 (100%) participants in the intervention group completed this survey at time of enrollment in the study (baseline).

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

Patients randomized into the intervention are assigned a lay health worker who will contact the patient to begin the intervention, including: 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 participants also receive usual care as provided by Unite Here Health and their local oncologists.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans	NCT02760537	Liver Neoplasms Hepatitis B	Lay Health Work... Placebo (a list...	18 Years -	Thomas Jefferson University
Lay Health Worker Engage, Educate, and Encourage Patients to Share	NCT03699748	End of Life Cancer	Lay Health Work... Usual Care	18 Years -	Stanford University
Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans	NCT02760537	Liver Neoplasms Hepatitis B	Lay Health Work... Placebo (a list...	18 Years -	Thomas Jefferson University

Spots Global Cancer Trial Database for lay health worker intervention