跳至主要内容
临床试验/NCT04585919
NCT04585919已完成不适用

Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

Harvard School of Public Health (HSPH)4 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
4
主要终点
Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care

研究概览

简要总结

This work is an implementation science study that examines different aspects of implementing a single intervention. The intervention consists of asking community health centers to implement an outreach strategy to screen patients for colorectal cancer and for social determinants of health in community health centers at the same contact point. These are both clinical targets that the CHCs feel that their patients need and want to offer at a higher rate. The intervention consists of outreach to patients in need of colorectal cancer screening (CRC) to offer fecal immunochemical test (FIT) screening and screening for social determinants of health (SDOH). In this implementation science study, the intervention is an evidence-based intervention being implemented in real-world clinical practice. The intervention is the outreach to offer FIT and SDOH, conducted by clinic staff. Both evidence-based screening activities-FIT and SDOH screening-are used in the practices included in the study but pairing them is intended to increase efficiency and patient-centeredness by addressing health related social needs that may impact patients' ability to engage in cancer screening. The study aims to test the effect of implementing the intervention on clinical and process outcomes. Clinical outcomes are CRC screening and SDOH screening. Analysis of process outcomes includes measuring what organizational factors influence implementation.

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

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

  • •Study participants include community health center staff participating in interviews about the implementation of the intervention. Up to four community health center staff members at each of the four community health centers will participate in key informant interviews twice per year. Patients will receive the paired screening intervention as part of their routine care and will not be individually recruited for the study because the intervention is being offered as part of routine care.
  • •Staff Participants
  • •Inclusion Criteria:
  • •Staff from community health centers who facilitate screening
  • •Age 18 and older

排除标准

  • •Have not participated in the implementation of the paired screening intervention

研究组 & 干预措施

Paired Screening Intervention

Experimental

干预措施: Paired Screening Intervention (Behavioral)

Usual Care Control

No Intervention

In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.

结局指标

主要结局

Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care

时间窗: 13 pre implementation months, 14 post-implementation months

Colorectal cancer screening completion by any guideline-based method. Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step.

Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care

时间窗: 13 pre implementation months, 14 post-implementation months

Completion of social needs screening (collected as part of routine clinical care). Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step.

次要结局

  • Number of FIT Kits Mailed(4 months post-implementation, 8 months post-implementation)
  • Number of Reminders Per FIT Mailing(4 months post-implementation, 8 months post-implementation)
  • Number of Reminders Per FIT Return(4 months post-implementation, 8 months post-implementation)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Emmons

Professor of Social and Behavioral Sciences

Harvard School of Public Health (HSPH)

研究点 (4)

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