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临床试验/NCT05693649
NCT05693649进行中(未招募)不适用

Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

Abramson Cancer Center at Penn Medicine2 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2023年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20,000
试验地点
2
主要终点
CRC screening completion at 3 years

研究概览

简要总结

This is a 3-year pragmatic, randomized clinical trial among average-risk patients at diverse primary care practices who are overdue for colorectal (CRC) screening. This project aims to evaluate the effect of a centralized program that includes direct outreach to patients and visit-based, clinician directed nudges facilitated by the electronic health record (EHR) with follow-up text messaging on the uptake of CRC screening. The primary outcome is CRC screening completion at 3 years. Patient and clinician factors impacting the experience and effectiveness of the intervention will be explored through surveys and qualitative interviews.

详细描述

Despite effective strategies for prevention, early detection, and treatment, colorectal cancer (CRC) remains the second leading cause of cancer death in the United States (US). While there have been considerable policy and system-level efforts to increase CRC screening rates, uptake remains well below national goals of 80% participation. Members of racial and ethnic minorities are even further behind. Approaches to increase population-based screening can consider [1] how screening is encouraged by targeting the clinicians who typically order or recommend the procedure or the patient who completes it; and [2] the kind of screening offered (e.g., colonoscopy or fecal immunochemical testing [FIT]). This project simultaneously tests interventions along both of these dimensions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Screening
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ages 50-72
  • Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
  • Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, MT-sDNA in the last 3 years).

排除标准

  • Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease
  • History of total colectomy, dementia or metastatic cancer
  • Currently on hospice or receiving palliative care
  • Uninsured or self-pay patients
  • Currently scheduled for a colonoscopy or sigmoidoscopy
  • Active order for multitarget stool DNA testing (MT-sDNA)
  • History of paraplegia or quadriplegia
  • Elevated chance of mortality within 3 years according to mortality risk algorithm
  • Active order for Fecal Immunochemical Test (FIT) in the last 60 days
  • Positive stool test (FIT or MT-sDNA) result in the last 5 years

结局指标

主要结局

CRC screening completion at 3 years

时间窗: 3 years

CRC screening completion at 3 years, which could be satisfied by any one of the following: colonoscopy completion at any time, negative FIT completed 2 times, or positive FIT followed by diagnostic colonoscopy within 1 year.

次要结局

  • Choice of test(3 years)
  • CRC screening rate(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shivan Mehta

Principal Investigator

Abramson Cancer Center at Penn Medicine

研究点 (2)

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