Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 主要终点
- self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records
研究概览
简要总结
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.
详细描述
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:
- Review the liver cancer education program guidebook in English, (developed by previous project R25).
- 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.
- 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.
- Test the pilot LHW implementation
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •foreign-born Asian American adults
- •18 years of age and older
- •unprotected (HbsAg-/HbsAb-)
排除标准
- 未提供
研究组 & 干预措施
Placebo (a list of resources)
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.
干预措施: Placebo (a list of resources) (Behavioral)
Lay Health Worker Intervention
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.
干预措施: Lay Health Worker Intervention (Behavioral)
结局指标
主要结局
self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records
时间窗: Seven months after mailing the results
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.
次要结局
未报告次要终点
