Provider Support and Patient Outreach in Lung Cancer Screening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 822
- Locations
- 2
- Primary Endpoint
- Completion of initial lung cancer screening (LCS)
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Screening
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 77 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Educational Activity (Other)
Group B (Providers): (survey)
Participants complete survey at baseline and end of study survey.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Counseling (Other)
Group B (Patients): (survey)
Patients undergo EHR review on study and complete telephone survey throughout the trial.
Intervention: Survey Administration (Other)
Group B (Patients): (survey)
Patients undergo EHR review on study and complete telephone survey throughout the trial.
Intervention: Electronic Health Record Review (Other)
Outcomes
Primary Outcomes
Completion of initial lung cancer screening (LCS)
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Ronald Myers
Professor - Medical Oncology
Thomas Jefferson University