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临床试验/NCT03929926
NCT03929926已完成不适用

Proactive Outreach and Shared Decision Making to Improve Lung Cancer Screening Rates Among Primary Care Patients

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 2,355 人开始时间: 2019年6月19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
2,355
试验地点
2
主要终点
Time to screening with low dose computed tomography (LDCT)

研究概览

简要总结

This trial studies how well proactive outreach and shared decision making works in improving lung cancer screening rates in primary care patients. Proactive outreach and shared decision making strategies may help to improve the detection of lung cancer at an earlier stage through screening.

详细描述

PRIMARY OBJECTIVES:

I. To compare the combined intervention group (Outreach Contact Group [OC]/Outreach Contact and Decision Counseling Group [OC-DCP]) versus the control usual care group (UC) with respect to time to screening with low dose computed tomography (LDCT).

SECONDARY OBJECTIVES:

I. To compare the combined intervention (OC/OC-DCP) and usual care (UC) groups with respect to the fraction of patients who are referred/scheduled for screening.

II. To compare the combined intervention (OC/OC-DCP) and usual care (UC) groups with respect to the proportion of the referred/scheduled patients who actually keep their screening appointment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

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

  • Had a recent office visit with a primary care physician in one of the study practices.
  • History of smoking (current or former) in the electronic health record (EHR).

排除标准

  • LDCT performed in the 12 months prior to study initiation according to EHR.
  • Diagnosis of lung cancer indicated in problem list in the EHR.

结局指标

主要结局

Time to screening with low dose computed tomography (LDCT)

时间窗: From the date of randomization to the date of screening (for those screened) or to the date of the review (for those not screened, "censored", assessed at 3 months

Will be assessed through a review of electronic health records data at the end of the study. The main analysis will compare the combined intervention group and the usual care group (Outreach Contact \[OC\]/OC-Decision Counseling Program \[DCP\] versus \[vs.\] usual care \[UC\]) with the Kaplan-Meier method and the log-rank test (stratified by practice). Further analyses will rely on Cox proportional hazards regression to explore the difference between OC and OC-DCP groups, as well as differences across practices and patient characteristics (age, gender, race, current vs. former smoking, etc.).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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