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临床试验/NCT04498052
NCT04498052已完成不适用

Evaluation of a Scalable Decision Support and Shared Decision Making Tool for Lung Cancer Screening

University of Utah2 个研究点 分布在 1 个国家目标入组 1,855 人开始时间: 2020年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,855
试验地点
2
主要终点
Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed

研究概览

简要总结

The purpose of this project is to increase appropriate low-dose computed tomography (LDCT) lung cancer screening through the development and wide dissemination of patient-centered clinical decision support (CDS) tools that (1) are integrated with the electronic health record (EHR) and clinical workflows, (2) prompt for shared decision making (SDM) when patients meet screening criteria, and (3) enable effective SDM using individually-tailored information on the potential benefits and harms of screening. The study will promote standard of care that is endorsed by the Centers for Medicare & Medicaid Services (CMS) and the US Preventive Services Task Force (USPSTF).

详细描述

The purpose of this project is to increase appropriate low-dose computed tomography (LDCT) lung cancer screening through the development and wide dissemination of patient-centered clinical decision support (CDS) tools that (1) are integrated with the electronic health record (EHR) and clinical workflows, (2) prompt for shared decision making (SDM) when patients meet screening criteria, and (3) enable effective SDM using individually-tailored information on the potential benefits and harms of screening. The study will promote standard of care that is endorsed by the Centers for Medicare & Medicaid Services (CMS) and the US Preventive Services Task Force (USPSTF). This project is supported both operationally and by an Agency for Healthcare Research and Quality (AHRQ) R18 grant.

This project will leverage Decision Precision, a validated Web-based tool for LDCT SDM developed at the Veterans Health Administration, as well as an initial version of Decision Precision+, an EHR-integrated version of the tool which can be accessed directly in the EHR and auto-populate relevant patient data in the tool instead of requiring manual data entry.

This study will be an 18-month interrupted time series study conducted at the University of Utah Health primary care clinics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

盲法说明

no masking due to the nature of the intervention

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • receives care at University of Utah primary care clinics;
  • does not already have lung cancer;
  • meets USPSTF criteria for LDCT screening (currently, age >= 55 years and <= 80 years old at the time of the visit; 30+ pack-year smoking history and current smoker or quit in the past 15 years).

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed

时间窗: Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period

The LCS care gap was considered closed if one or more of the following events occurred: (1) LDCT completion in the past year, (2) completion of another chest CT in the past year, or (3) SDM documentation in the past 3 years for eligible patients. To assess population care-gap closure levels at the end of each study period, we estimated the care-gap closure status for all patients who had primary care visits in the 12 months preceding the last day of the period. Using structured EHR data, SDM was considered documented if a clinician noted the need for LCS discussion was addressed, the patient declined screening, or LCS was not appropriate.

次要结局

未报告次要终点

研究者

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

Kensaku Kawamoto, MD, PhD, MHS

Associate Chief Medical Information Officer

University of Utah

研究点 (2)

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