Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking

Study Overview
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Brief Summary
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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
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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: I. Assess intervention impact on: Ia. LCS referral; Ib. Tobacco treatment services referral; Ic. Repeat annual LCS among participants with a normal initial screening result; Id. Follow-up diagnostic evaluation for participants with an abnormal screening result. OUTLINE: Providers are randomized to 1 of 2 groups. Patients are randomized to 1 of 2 groups. PROVIDERS: GROUP A: PROVIDER SUPPORT GROUP: Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study. GROUP B: PROVIDER CONTROL GROUP: Participants complete survey at baseline and end of study survey. PATIENTS: GROUP A: Patients undergo electronic health records (EHR) review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study. GROUP B: Patients undergo EHR review on study and complete telephone survey throughout the trial.

Official Title
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Provider Support and Patient Outreach in Lung Cancer Screening

Conditions
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Lung Carcinoma, Tobacco-Related Carcinoma

Intervention / Treatment
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* Other: Survey Administration
* Other: Educational Activity
* Other: Survey Administration
* Other: Electronic Health Record Review
* Other: Educational Activity
* Other: Counseling
* Other: Survey Administration
* Other: Electronic Health Record Review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Providers): (survey, online educational activity)<br>Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study. | Other: Survey Administration<br>* Complete survey<br>Other: Educational Activity<br>* Undergo online shared decision making training and distance learning<br>|
| Active Comparator: Group B (Providers): (survey)<br>Participants complete survey at baseline and end of study survey. | Other: Survey Administration<br>* Complete survey<br>|
| Experimental: Group A (Patients): (EHR, educational activity, counseling))<br>Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study. | Other: Electronic Health Record Review<br>* Undergo electronic health record review<br>Other: Educational Activity<br>* Undergo online shared decision making training and distance learning<br>Other: Counseling<br>* Undergo shared decision making counseling<br>* Other names: Counseling Intervention;|
| Active Comparator: Group B (Patients): (survey)<br>Patients undergo EHR review on study and complete telephone survey throughout the trial. | Other: Survey Administration<br>* Complete survey<br>Other: Electronic Health Record Review<br>* Undergo electronic health record review<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of initial lung cancer screening (LCS) | 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. | Within 4 months of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referral for LCS | Referrals for lung cancer screenings will be found by reviewing electronic medical records. | Up to 5 years | 
| Tobacco cessation services | Referrals for tobacco treatment services will be found by reviewing medical records. | Up to 5 years | 
| Repeat annual lung cancer screenings within 11-16 months of original screening | Number of repeat screenings will be found by reviewing electronic medical records. | within 11-16 months of original screening | 
| Diagnostic follow up after initial lung cancer screening | Number of patients that had follow up within 4 months of initial lung cancer screening will be found by reviewing electronic medical records. | Up to 4 months of screening |