Implementing Guidelines for Shared Decision Making in Lung Cancer Screening (QUE 15-286)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,033
- 试验地点
- 8
- 主要终点
- Odds Ratio of the Interaction Between Lung Cancer Risk and Implementation Arm
研究概览
简要总结
The overall goal of this project is to test two strategies for implementing a shared decision making tool to be used by providers while talking to patients about lung cancer screening. Eight participating sites will be randomized to compare standard implementation with intensive implementation. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will survey patients to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.
详细描述
The overall goal of this quality improvement project is to test two strategies for implementing shared decision making, which incorporates the Decision Precision lung cancer screening tool. The investigators will use multi-site, cluster-based randomization to compare standard implementation with intensive implementation. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will have a human subjects research component to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •Patients at participating sites without documented exclusions for lung cancer screening who have had initial lung cancer screening clinical reminders resolved during the recruitment period
排除标准
- •Exclusions for initial lung cancer screening clinical reminders:
- •history of lung, pancreatic, liver or esophageal cancer
- •a health factor on file indicating they have a life expectancy of less than 6 months or who already had a chest CT in the past 12 months
结局指标
主要结局
Odds Ratio of the Interaction Between Lung Cancer Risk and Implementation Arm
时间窗: post implementation, an average of 15 months
First, we estimated screening's net benefit for an individual based on their baseline lung cancer risk, as estimated using the Bach et. al. annual lung cancer incidence model. Patients are considered "high benefit" if their annual lung cancer risk is between 0.3%-1.3%. Patients outside this range are considered "preference sensitive". We fit a multilevel logistic regression model where receipt of screening is the outcome. Precision decision making is reflected in the association between baseline lung cancer risk and screening utilization: an increase in screening utilization for those at higher lung cancer risk indicates some degree of precision decision making. The primary outcome for the cluster-randomized design assesses the difference in precision decision making in the standard vs. intensive implementation arms. This is estimated as the effect on screening receipt of the interaction between risk and implementation arm.
Patient Satisfaction With Decision and Process
时间窗: Survey mailed to Veteran several weeks after identified as having an initial discussion about lung cancer screening using VA administrative data
Obtained from patient surveys (for the subset of the overall participants who returned surveys). The unit of measurement is one unit on the scale \[scale of 0 (very poor) to 10 (very good)\].
次要结局
- Number of Tool Assessments Where Patient Decision Aid Was Printed(post implementation, up to 25 months)
- Number of Times Dynamic Pictograph Depicting Personalized Benefit and Harm Was Opened for Display(post implementation, up to 25 months)
- Formative Evaluation to Determine the Factors Most Important for Successful Implementation of Decision Precision Tool(At least one year post-implementation of Lung Decision Precision web-site)