A Multi-Level Intervention for Improving Screening Rates of Breast, Cervical and Colorectal Cancer in Women in Low-Income Communities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,067
- 试验地点
- 2
- 主要终点
- Up to date (UTD) status for all three screenings (Early Intervention Wave)
研究概览
简要总结
This clinical trial develops and tests how well a multi-level intervention (MLI), The Ohio State University (OSU) SCREEN Community Program, works to increase screening and follow-up for breast, cervical and colorectal (CRC) cancer among low-income and un/underinsured female residents in three counties in Central Ohio. In Ohio, incidence and mortality rates for breast, cervical and CRC are higher than or similar to the national average; in addition, underserved populations - minority, rural and low-income women - have higher rates of these cancers. Screening can detect precancerous colorectal and cervical lesions and other early-stage cancers when treatment is less intensive and more successful and is known to reduce mortality rates for breast, cervical, and CRC, however many of these women lack access to health care and screenings. This MLI includes clinic-based components, such as patient education, as well as community-based strategies, such as media programs and training health workers, that can increase rates of guideline-recommended breast, cervical and CRC screening and follow-ups in underserved populations. The OSU SCREEN Community Program may be an effective way to improve breast, cervical and CRC screenings among underserved women in Ohio.
详细描述
PRIMARY OBJECTIVES:
I. Understand local factors and context relevant to breast, cervical and CRC screening and follow-up (including referral-to-care) and develop an MLI planning and implementation pathway for use by partner health centers and communities (Year 1).
II. Pilot test and further refine the MLI planning and implementation process in one clinic (Years 1 & 2).
III. Test the final MLI planning and implementation process in a group randomized, delayed intervention trial to assess the impact of the customized MLI on increasing rates of guideline recommended breast, cervical and CRC screening and follow-up for abnormal tests (Years 2, 3 and 4).
IV. Assess sustainability of the MLI (Years 4 and 5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Level 1 is the health clinics (Helping Hands [pilot]; 6 Lower Lights clinics). Clinics are eligible if they provide preventive health care to residents of the targeted census tracts.
- •Level 2 focuses on health care providers (physicians, nurses, physician assistants [PA]/nurse practitioners [NPs]) and office staff practicing at participating clinics who are involved in the screening and/or screening referral process (determined by individual clinical sites) and can speak, read, and write English
- •Patients (Level 3) are the recipients of health care and screening interventional strategies implemented by clinics and providers.
- •Level 4 is the community to include residents in targeted census tracts around each clinic.
排除标准
- 未提供
结局指标
主要结局
Up to date (UTD) status for all three screenings (Early Intervention Wave)
时间窗: At baseline and at the end of the Implementation Phase (up to 4 years)
Will be assessed by the difference in proportions of being UTD with all age-appropriate screening tests using electronic health record (EHR) data. Rates will be examined by age, race/ethnicity, residence, payer status, provider, time since last visit, and rates of other cancer screening. Repeated measure Generalized Estimating Equations (GEE) models with compound symmetry correlation structure and robust variance will be used to compare change between the early and delayed intervention groups adjusting for baseline UTD screening rates of the targeted communities. Adjustment for baseline UTD screening rates and rates of follow up for abnormal test will control for any differences by intervention group due to chance and will increase power by decreasing the standard error of the treatment effect. To account for differences in number of respondents across targeted communities, GEE models will be weighted using an approach described by Johnson et al.
Status of follow-up for abnormal tests (Early Intervention Wave)
时间窗: At baseline and at the end of the Implementation Phase (up to 4 years)
Will be assessed by the difference in follow-up rates for abnormal tests using EHR data. GEE models with compound symmetry correlation structure and robust variance will be used to compare change between the early and delayed intervention groups adjusting for baseline UTD screening rates of the targeted communities. Adjustment for baseline UTD screening rates and rates of follow up for abnormal test will control for any differences by intervention group due to chance and will increase power by decreasing the standard error of the treatment effect. To account for differences in number of respondents across targeted communities, GEE models will be weighted using an approach described by Johnson et al.
次要结局
- UTD screening status for all three cancers and follow up rates for abnormal tests(At the end of early intervention (up to 2.5 years))
研究者
Electra Paskett
Principal Investigator
Ohio State University Comprehensive Cancer Center