Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- Primary Outcome is Clinic Attendance
研究概览
简要总结
The purpose of this study is to test the effectiveness of a two-phase intervention using "community-to-clinic navigators" to guide individuals from an especially hard-to-reach, multicultural, and underinsured population into primary care clinics and, subsequently, to track effects of the intervention on completion of colorectal cancer (CRC) screening in clinics. A cost-effectiveness analysis will lay the foundation for further implementation and dissemination research.
Aim 1: Test effectiveness of community group education + tailored navigation versus community group education only in increasing clinic attendance among low-income, multicultural Arizona residents, aged 50 to 75 yrs.
Hypothesis 1: Individuals receiving group education classes + tailored navigation will show higher rates of clinic attendance than those receiving only group education.
* As a separate critical step for those who make clinic appointments, the investigators will examine the effect on follow through to screening, using initial group assignment as a control variable in analysis. Patients making clinic appointments will receive referral for screening and tailored navigation as usual care.
Aim 2: Track outcomes of the Phase I intervention on CRC screening test completion among low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic.
Hypothesis 2: Individuals receiving group classes and tailored navigation during Phase I will have higher rates of CRC screening test completion than those receiving classes only, (however this outcome will be primarily due to clinic attendance).
Aim 3: Determine the cost-effectiveness of each phase of the interventions on increasing CRC screening completion among low-income, multicultural Arizona residents aged 50 to 75 years.
Exploratory Aim 4: Examine the levels of program dissemination from community to clinic to final screenings using the RE-AIM model.
Research Question 2: What is the degree of Reach, Efficacy, Adoption, Implementation, and Maintenance of the community-to-clinic navigation, and clinic-to-screening outcomes?
详细描述
Design overview:
This study will employ a 2-phase experimental, randomized design to test a community to clinic navigation intervention: (1) to increase attendance at primary care clinics (Phase I), and (2) to track CRC screening among those who visit clinics (Phase II). The investigators will recruit non-adherent individuals from multicultural community sites in low-income zip codes in the Phoenix Arizona metropolitan area.
In Phase I, community sites will be randomized to either group education (GE) or group education plus tailored navigation (GE +TN) to increase attendance at the primary care clinics. In Phase II, individuals who complete a clinic appointment (from Phase I) will then receive the standard of care (provider prompts, navigation calls to patients) in the clinic. Phase I brings individuals into the primary care system (clinic attendance), and Phase II follows them through to CRC screening completion (either stool-based or colonoscopy). An accelerated plan will be initiated for individuals identified as at high risk for CRC, referring them for colonoscopy, to realistically evaluate effects of the interventions in real-world conditions, including the range of patient risk profiles in this setting. Recruitment, intervention, and data collection materials have been developed in English and Spanish and reviewed by a Cultural Community Advisory Board (CCAB) for cultural fit across our multicultural population of low-income participants.
Intervention details:
Group education (Phase I): Groups will be assembled for an educational class after all baseline surveys are completed for a community site. The curriculum for the 60 minute class will include:
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Phase I Inclusion criteria:
- •participants will be aged 50-75,
- •speak either English or Spanish,
- •live in low-income neighborhoods (including a range of race and ethnicity),
- •are due for CRC screening,
- •may be at average or high risk for CRC,
- •either will not identify a regular clinic they attend or will be registered (or identify) with one of the clinic systems engaged in our study. Those who do identify a clinic home, however, will also be encouraged to join the study as long as they are due for screening.
- •Phase II Inclusion criteria:
- •Participants who keep their clinic appointment from Phase I will be enrolled in the study by clinic navigators and the Phase I inclusion criteria (above) will be re-confirmed.
排除标准
- •Individuals who are compliant with CRC screening guidelines will not be eligible.
- •While we will not intentionally exclude any specific racial/ethnic group, our study materials are offered in Spanish and English. As such, anyone who does cannot speak, read, and write English or Spanish will not be eligible to participate in the study.
研究组 & 干预措施
Tailored Navigation
Participants will receive tailored navigation phone calls to assist them with barriers in making a clinic appointment or attending the clinic. The tailored navigation intervention protocol will be used to guide individuals from an especially hard-to-reach, multicultural, and underinsured population into primary care clinics and, subsequently, track the effects of this intervention through a clinic navigation program to complete Colorectal cancer screening.
干预措施: Tailored navigation (Behavioral)
Control
Participants in the control arm will receive phone calls to support data collection and tracking, but not receive tailored messages
结局指标
主要结局
Primary Outcome is Clinic Attendance
时间窗: Attendance at the community educational class and 8 weeks beyond to attendance at a clinic.
Track outcomes of the Phase I intervention on colorectal cancer (CRC) screening test completion among low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic.
次要结局
- The Secondary Outcome is Participant Completion of a CRC Screening Test.(At 3- and 6-months post clinic visit, we will collect screening data from patient self-report and medical chart reviews.)