Implementing Multilevel Colon Cancer Screening Interventions to Reduce Rural Cancer Disparities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185,903
- 试验地点
- 1
- 主要终点
- Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test
研究概览
简要总结
Less than half of all positive fecal immunochemical testing (FIT)s are followed-up by colonoscopy, thus limiting the full potential of colorectal cancer (CRC) screening to reduce mortality. Given the need for coordination in order to achieve high rates of follow-up, multilevel approaches are needed. Such approaches could be particularly beneficial in communities and populations that experience cancer disparities and have fewer specialty providers, but most data focuses on large systems or urban areas. The academic-community health system collaboration is uniquely poised to address this research and service gap. The persistent poverty and health disparities in rural Southern Illinois set the stage for truly impactful research. The investigators' approach will serve as a model for multilevel interventions in rural settings, inform future work addressing other health disparities, and fill a gap in rigorous trials of CRC screening follow-up in rural areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Primary Care Clinic Sites
- •Physician Hospital Organization (PHO) affiliated with Southern Illinois Healthcare
排除标准
- •for Primary Care Clinic Sites
- •Not a part of the PHO
- •Inclusion Criteria for Physicians and Staff at Primary Care Clinic Sites
- •Employment at the relevant clinic at the time of the study
- •Exclusion Criteria for Physicians and Staff at Primary Care Clinic Sites
- •Not employed at the relevant clinic at the time of the study
- •Inclusion Criteria for Patients
- •Age 45-75 during the study period
- •Must be patient of the selected primary care clinic sites
- •Exclusion Criteria for Patients
- •Younger than 45 years of age or older than 75 years of age during the study period
- •Not a patient of the selected primary care clinic sites
- •Inclusion Criteria for Community Members
- •Age 45-75 at the time of the health fair or screening event
- •Able to undergo stool testing as determined by SIH staff at the health fair or screening event
- •Exclusion Criteria for Community Members
- •Younger than 45 years of age or older than 75 years of age
- •Unable to undergo stool testing
研究组 & 干预措施
Primary Care Clinics
- Southern Illinois Healthcare System will contact the site management and ask for participation in the study
- Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.
- At least 6 months of control data collection before clinics begin receiving the intervention.
干预措施: Colorectal Cancer Toolkit (Other)
结局指标
主要结局
Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test
时间窗: Within 60 days after receipt of positive FIT/FOBT
* Patients between 07/01/2021 - 12/31/2024 that had a fecal immunochemical test (FIT)/fecal occult blood test (FOBT) test performed with a positive result and had an ambulatory referral to Gastroenterology within 60 days of getting the results from the lab test. * Separate data for the Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start \& major delays \& staff shortages due to COVID shutdowns, which prevented the collection of colonoscopy referrals. The referral data was obtained from the hospital sites that used EPIC but could not be differentiated by arms. Data for the remaining outcome measures was able to be differentiated by arm as the data came from the registry versus EPIC.
Number of Colonoscopy Completions After Positive Fecal Immunochemical Test (FIT)
时间窗: Within 60 days of referral to Gastroenterology
次要结局
- Time to Colonoscopy(Through completion of follow-up (range of 91-1278 days): mean=844 days, standard deviation=440 days)
- Proportion of Participants Who Initiate a Colonoscopy Within 14 Days of Positive Fecal Immunochemical Test(Within 14 days of positive fecal immunochemical test)
- Proportion of Patients Who Complete a Complete Diagnostic Evaluation Within 60 Days of Positive Fecal Immunochemical Test(Within 60 days after receipt of positive FIT/FOBT)