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临床试验/NCT06625983
NCT06625983已完成不适用

Colorectal Cancer Screening Decision Support Tool in the Primary Care Bundle Questionnaire

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 9,205 人开始时间: 2024年10月16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
入组人数
9,205
试验地点
2
主要终点
CRC screening completion

研究概览

简要总结

The research question we pose is, Does a colorectal cancer (CRC) screening decision support tool offered in advance of primary care visits increase CRC screening completion rates? Our work aims to answer this question by evaluating the effectiveness of an MGB decision support tool to 1) promote informed decisions about CRC screening for average risk patients ages 45-75, 2) deploy a decision support tool as part of a primary care bundle questionnaire, and 3) support patients in completing their preferred method of CRC screening.

详细描述

As part of usual care, a CRC screening electronic decision support tool developed by Mass General Brigham has been integrated into Epic. This decision support tool is part of routine clinical care and is sent electronically to patients aged 45-75 who receive the Annual Visit Primary Care Screening Bundled Questionnaire in advance of their annual visit. Patients complete the tool on Patient Gateway prior to the visit or via an iPad at the visit. The decision support tool guides patients through the CRC screening options (e.g., FIT, colonoscopy, Cologuard) to help them select their preferred screening method. As part of routine care, the patient will be prompted to complete the tool as part of the bundled questionnaire, and the results will be available in the Epic encounter in the Screenings tab with the other screening bundle responses. The primary care clinician can then discuss the options and/or screening preference with the patient. Depending on what the patient and clinician decide, a CRC screening test may be ordered for the patient. As a secondary outcome, a random sample of 1000 patients will be surveyed to understand their involvement in the decision making process and 300 providers will be surveyed to understand how the decision tool impacted the conversation with the patient. The IRB to conduct surveys of patients and providers was approved by the Mass General Brigham IRB (Protocol # 2024P002568).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Adults aged 45-75 overdue for CRC screening at average risk of CRC have an annual visit scheduled with participating practices

排除标准

  • high risk of CRC

研究组 & 干预措施

CRC decision tool

Experimental

intervention arm

干预措施: CRC decision tool (Other)

control

No Intervention

control arm

结局指标

主要结局

CRC screening completion

时间窗: 12 months

Assessment of electronic health record data to determine completion of CRC screening by any modality

CRC screening completion

时间窗: 6 months

Assessment of electronic health record data to determine completion of CRC screening by any modality

次要结局

  • Provider Experience(During the 6 month intervention phase)
  • Shared Decision Making Process Measure(During the 6 month intervention phase)

研究者

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

Karen J. Blumenthal, MD, MPH

Internist

Massachusetts General Hospital

研究点 (2)

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