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临床试验/NCT04612946
NCT04612946已完成不适用

Using Connected Health to Increase Lung Cancer Screening: Single Center Randomized Pilot Trial

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2021年2月10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
137
试验地点
2
主要终点
Completion of LCS counseling

研究概览

简要总结

This study will consist of two primary aims designed to help advance quality and utilization of lung cancer screening (LCS) within an academic and community-based medical system. The objective of Aim 1 is to pilot test the effect and feasibility of using direct outreach and telemedicine to increase LCS counseling and LDCT uptake among screening-eligible patients. Patients who confirm eligibility and agree to participate will be randomized into two study arms: 1) usual care or 2) telemedicine LCS counseling referral. For Aim 2, each arm will first complete a baseline survey to explore how individual beliefs and knowledge impact screening intention and uptake. Patients in both arms will also receive brief information on lung cancer screening guidelines and be asked to report LCS-related preferences after exposure to the information. All interventions will be administered using a secure, web-based platform.

详细描述

In 2013, the United States Preventive Services Task Force (USPSTF) provided a Grade "B" recommendation for annual lung cancer screening (LCS) for asymptomatic adults aged 55-80 who are or have been heavy smokers (≥30 pack-years of smoking and quit-date < 15 years ago), and are able to undergo surgery. In 2015, The Centers for Medicare and Medicaid Services (CMS) issued national coverage for LCS requiring that LCS counseling, which must include shared decision-making and tobacco cessation counseling, occur prior to LCS. CMS also provides reimbursement for LCS counseling to further support providers to engage in meaningful, collaborative conversations about LCS with patients. Despite widespread support, uptake and implementation of LCS across the United States has been low (estimated 3-5% screening-eligible population screened). Locally, since the onset of the Penn Medicine LCS Program in 2014, over 3,500 individual patients have received LCS; however, documentation and reimbursement of LCS counseling are limited.

Challenges of implementing LCS include substantial barriers to identifying screening-eligible patients, supporting high-quality decision-making, and remaining uncertainties regarding risks and benefits. For other types of cancer screening, insights from behavioral science have been applied to understand how cognitive biases and beliefs impact screening uptake. Yet for LCS, there is limited evidence on how these beliefs may affect screening behaviors in routine practice. Given the complexities of LCS, in which the benefits do not clearly outweigh the harms, understanding how these biases impact screening can help inform development of intervention strategies that both support informed decision-making and increase uptake among eligible patients. Leveraging an existing EMR-based data warehouse, this study will combine insights from behavioral economics and connected health strategies to pilot test connected health approaches including direct patient outreach and telemedicine visits to improve LCS counseling, and to explore individual-level moderators of LCS screening intention and uptake. The long-term goal is to decrease lung cancer burden by increasing utilization of LCS and providing clinicians and patients with effective strategies to deliver high-quality, patient-centered care. This study will also advance scientific understanding of the mechanisms that drive or hinder health behavior in the context of cancer prevention.

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
Single (Outcomes Assessor)

盲法说明

Primary analyst and statistician will be blinded to the randomization assignment. The investigators and research coordinators will be unblinded to facilitate coordination with telehealth referral. The analyst will create the randomization assignments on a master list (using Stata) and enter into REDCap using the randomization module (stratified by batch). Assignments will be maintained by the research coordinator on a password protected computer. The blind may be broken in the case of an emergency.

入排标准

年龄范围
55 Years 至 77 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Had a primary care visit at the healthcare system within the last 24 months
  • No history of lung cancer
  • Heavy smokers (30+ pack year and current smoker or quit within 15 years)
  • Access to phone and internet
  • English-speaking
  • Have an assigned primary care provider at recruiting practices
  • Never received LCS within the healthcare system

排除标准

  • Aged <55 or >77 years
  • Did not have a primary care visit at the healthcare system within the last 24 months
  • History of lung cancer
  • Smoking history of <30 pack years
  • No access to phone and internet
  • Inability to speak English
  • Does not have an assigned primary care provider at recruiting practices
  • History of LCS within the healthcare system

结局指标

主要结局

Completion of LCS counseling

时间窗: Initial measurement will occur within 8 weeks of baseline survey

The primary outcome measure is completion of LCS counseling, defined by completion of a telemedicine visit, in-person counseling visit (CPT G0296), or documentation of counseling in EHR provider notes.

次要结局

  • Completion of LDCT scan for LCS(Within 6 months following baseline survey)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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