Provider Support and Patient Outreach in Lung Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 822
- 试验地点
- 2
- 主要终点
- Completion of initial lung cancer screening (LCS)
研究概览
简要总结
This clinical trial tests how well providing education improves screening for lung cancer in patients with a history of smoking. Screenings may help doctors find lung cancer sooner when it may be easier to treat. Education and counseling may be an effective method to help providers and patients learn about lung cancer screening. Providing education and decision counseling to providers and patients may increase lung cancer screening.
详细描述
PRIMARY OBJECTIVES:
I. Assess intervention impact on lung cancer screening (LCS). II. Assess intervention impact on shared decision making (SDM).
SECONDARY OBJECTIVES:
I. Identify mediators and moderators of LCS. II. Assess intervention implementation barriers and facilitators.
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PRACTICE LEVEL:
- •Primary care practice (family medicine, geriatrics, internal medicine) in one of the 4 participating health systems
- •Practice using the main electronic medical record (EMR) of each system, in order to run appropriate patient recruitment reports
- •Practice with at least 50% of practice providers (physicians and advanced care providers) consenting to participate
- •PATIENT LEVEL:
- •Have an office or telemedicine established patient visit scheduled with a primary care provider in one of the participating practices within next 14 to 25 days
- •50 to 77 years of age
- •Have at least a 20-pack-year smoking history (based on self-report at baseline eligibility assessment)
- •Currently smoke or have quit smoking within the past 15 years (based on self-report at baseline eligibility assessment)
- •Able to communicate in English or Spanish (determined at baseline eligibility assessment)
排除标准
- •PATIENT OUTREACH:
- •Any lung computed tomography (CT) or low-dose computed tomography (LDCT) scan in the past 11 months, current procedural terminology (CPT) Codes are as follows
- •G0297 - LDCT screening
- •71250 - CT w/o contrast
- •71260 - CT w/ contrast
- •71270 - CT with and w/o contrast
- •71275 - CT angiography chest
- •78815 - Positron emission tomography computed tomography (PET CT) skull base to mid-thigh
- •78816 - PET CT whole body
- •Prior history of lung cancer (The patient's problem list includes a problem with an international classification of diseases (ICD10) code of "Z85.118" or one beginning with "C34.", or by self-report at baseline eligibility assessment)
- •Recent hospitalization (Admission date within the last 60 days listed in electronic health record (EHR), or by self-report at baseline eligibility assessment)
- •Dementia (diagnosis codes F03.90 or F03.91) in EHR
研究组 & 干预措施
Group A (Providers): (survey, online educational activity)
Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.
干预措施: Survey Administration (Other)
Group A (Providers): (survey, online educational activity)
Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.
干预措施: Educational Activity (Other)
Group B (Providers): (survey)
Participants complete survey at baseline and end of study survey.
干预措施: Survey Administration (Other)
Group A (Patients): (EHR, educational activity, counseling))
Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.
干预措施: Electronic Health Record Review (Other)
Group A (Patients): (EHR, educational activity, counseling))
Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.
干预措施: Educational Activity (Other)
Group A (Patients): (EHR, educational activity, counseling))
Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.
干预措施: Counseling (Other)
Group B (Patients): (survey)
Patients undergo EHR review on study and complete telephone survey throughout the trial.
干预措施: Survey Administration (Other)
Group B (Patients): (survey)
Patients undergo EHR review on study and complete telephone survey throughout the trial.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Completion of initial lung cancer screening (LCS)
时间窗: Within 4 months of randomization
LCS will be assessed through an endpoint electronic medical records (EMR) search, supplemented with a question on the participant endpoint survey to capture any LCS performed outside the health system and/or not captured in the EMR.
次要结局
- Tobacco cessation services(Up to 5 years)
- Referral for LCS(Up to 5 years)
- Repeat annual lung cancer screenings within 11-16 months of original screening(within 11-16 months of original screening)
- Diagnostic follow up after initial lung cancer screening(Up to 4 months of screening)
研究者
Ronald Myers
Professor - Medical Oncology
Thomas Jefferson University