Community collaboration to advance racial/ethnic equity in colorectal Cancer screening: Protocol for a multilevel intervention to improve screening and follow-up in community Health centers

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-07-26 DOI:10.1016/j.cct.2024.107639
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Abstract

Introduction

Colorectal cancer (CRC) screening utilization is low among low-income, uninsured, and minority populations that receive care in community health centers (CHCs). There is a need for evidence-based interventions to increase screening and follow-up care in these settings.

Methods

A multilevel, multi-component pragmatic cluster randomized controlled trial is being conducted at 8 CHCs in two metropolitan areas (Boston and Los Angeles), with two arms: (1) Mailed FIT outreach with text reminders, and (2) Mailed FIT-DNA with patient support. We also include an additional CHC in Rapid City (South Dakota) that follows a parallel protocol for FIT-DNA but is not randomized due to lack of a comparison group. Eligible individuals in participating clinics are primary care patients ages 45–75, at average-risk for CRC, and overdue for CRC screening. Participants with abnormal screening results are offered navigation for follow-up colonoscopy and CRC risk assessment.

Results

The primary outcome is the completion rate of CRC screening at 90 days. Secondary outcomes include the screening completion rate at 180 days and the rate of colonoscopy completion within 6 months among participants with an abnormal result. Additional goals are to enhance our understanding of facilitators and barriers to CRC risk assessment in CHC settings.

Conclusions

This study assesses the effectiveness of two multilevel interventions to increase screening participation and follow-up after abnormal screening in under-resourced clinical settings, informing future efforts to address CRC disparities.

Trial Registration

NCT05714644

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社区合作促进结直肠癌筛查中的种族/民族平等:改善社区卫生中心筛查和随访的多层次干预方案。
导言:在社区卫生中心(CHC)接受治疗的低收入、无保险和少数民族人群中,大肠癌(CRC)筛查利用率较低。有必要采取循证干预措施,以提高这些机构的筛查率和后续护理率:我们正在两个大都市地区(波士顿和洛杉矶)的 8 家社区健康中心开展一项多层次、多成分的实用群组随机对照试验,试验分为两部分:(1)邮寄 FIT 宣传资料并附带短信提醒;(2)邮寄 FIT-DNA 资料并附带患者支持。我们还将拉皮德市(南达科他州)的另一家 CHC 纳入其中,该 CHC 遵循 FIT-DNA 的平行方案,但由于缺乏对比组而未进行随机分组。参与诊所的合格患者为 45-75 岁的初级保健患者,他们的 CRC 风险处于平均水平,并且逾期未接受 CRC 筛查。筛查结果异常的参与者将接受后续结肠镜检查和 CRC 风险评估:结果:主要结果是 90 天的 CRC 筛查完成率。次要结果包括 180 天的筛查完成率以及结果异常的参与者在 6 个月内完成结肠镜检查的比率。其他目标是加强我们对 CHC 环境中 CRC 风险评估的促进因素和障碍的了解:本研究评估了两种多层次干预措施在资源不足的临床环境中提高筛查参与率和异常筛查后随访率的效果,为今后解决 CRC 不均衡问题提供了参考:试验注册:NCT05714644。
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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