iNUDGE: INtegration of liqUiD Biopsy Based Next Generation Gene sEquencing in Newly Diagnosed NSCLC - A Stepped Wedge Cluster Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
- 试验地点
- 10
- 主要终点
- Availability of comprehensive molecular test results prior to first line therapy for patients with newly diagnosed mNSq NSCLC
研究概览
简要总结
This study expands the application of an electronic health record (EHR) "nudge" used to prompt physicians' clinical practice to order molecular testing at the time of initial diagnosis for patients with specific types of advanced lung cancer. The primary goal is to have these test results available prior to starting treatment so that physicians can make molecularly-informed treatment decisions. The second goal is to better understand factors that contribute to whether or not the EHR-nudge implementation is successful.
详细描述
At the University of Pennsylvania Health System (UPHS), a behavioral economics (BE) informed "nudge" strategy was piloted to guide physicians' clinical practice to include concurrent use of plasma and tissue-based next generation sequencing (NGS) testing at the time of initial diagnosis for patients with newly diagnosed metastatic non-squamous (mNSq) non-small cell lung cancer (NSCLC). These findings have demonstrated that behavioral, electronic health record (EHR)-based nudges are feasible and can promote guideline concordant diagnostic testing at both community and academic sites.
The overarching goal of this current trial is to expand the application of the BE informed nudges, which includes a Best Practice Advisory (BPA) and Electronic Decision Support Tool (e-CDS) approach, which has been operationalized within Epic, the EHR used at UPHS, to six satellite hospitals. Our central hypothesis is that this approach will dramatically increase adoption of comprehensive molecular testing and enhance the delivery of molecularly informed 1L therapy in patients with newly diagnosed mNSq NSCLC.
Intervention: A multicomponent BE-informed EHR-based nudge designed to facilitate comprehensive molecular testing by embedding a default P-NGS order into the EHR at the time of the NPV. If ordered, test results are incorporated into provider workflows and conveyed through electronic clinical decision support (e-CDS) notifications. This support program will notify clinicians of targetable mutations, potential clinical trials, as well as absence of mutations detected on plasma testing as a means of improving the timely delivery of molecularly informed therapy.
Study Design
Objective 1: In a stepped wedge cluster randomized trial of newly diagnosed patients with mNSq NSCLC, evaluate the effectiveness of a multicomponent BE-informed EHR-based nudge intervention at increasing timely receipt of comprehensive molecular test results prior to 1L therapy by incorporating P-NGS into the standard clinical workup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
This intervention is directed towards physicians. Individuals will not be randomized.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a histological, or cytological diagnosis of metastatic non-squamous (mNSq) non-small cell lung cancer (NSCLC) who have not yet received systemic treatment for metastatic disease.
- •Participants must be seen at Lancaster General Health (LGH), Penn Presbyterian Medical Center (PPMC), Penn Medicine Cherry Hill (PMCH), Penn Medicine Princeton Health (PMPH), Penn Medicine Voorhees (PMV) or Penn Medicine Washington Township (PMWT) for mNSq NSCLC.
排除标准
- •Participants with incomplete staging information.
- •Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study.
研究组 & 干预措施
Penn Medicine New Jersey
All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.
干预措施: iNUDGE (Behavioral)
Penn Medicine Lancaster General Health
All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.
干预措施: iNUDGE (Behavioral)
Penn Presbyterian Medical Center
All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.
干预措施: iNUDGE (Behavioral)
结局指标
主要结局
Availability of comprehensive molecular test results prior to first line therapy for patients with newly diagnosed mNSq NSCLC
时间窗: Measured up to 6 weeks from initial diagnosis
Were comprehensive molecular test results available prior to initiation of 1L therapy? (Yes/No)
次要结局
- Turnaround time of delivery of provider focused alerts(Measured up to 6 weeks from randomization)
- Successful EHR based nudge delivery(Measured up to 6 weeks from randomization)
- Reasons for failure to complete comprehensive molecular testing:(Measured up to 3 months from initial diagnosis)
- Type of therapy received(Measured up to 3 months from initial diagnosis)
- Overall survival(Measured up to 1 year from the time of randomization to death from any cause)
- Completion of comprehensive molecular testing & modality used(Measured up to 3 months from initial diagnosis)
- Time to molecularly informed treatment initiation(Measured up to 6 weeks from initial diagnosis)
研究者
Charu Aggarwal
Leslye M. Heisler Associate Professor of Lung Cancer Excellence and Associate Director, Penn Center for Precision Medicine
Abramson Cancer Center at Penn Medicine