Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention

Study Overview
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Brief Summary
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This study evaluates the feasibility of a clinical informatics system-based approach to lung cancer screening. Patients of a large academic medical center who may qualify for lung cancer screening will be sent an electronic invitation to complete an online lung cancer screening decision aid.

Detailed Description
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The Center for Medicaid and Medicare Services (CMS) recently approved the use of low-dose chest CT scans for lung cancer screening in patients who meet specific criteria. However, many individuals who meet these criteria do not realize they qualify for screening. This study will determine the feasibility of using a clinical informatics approach to systematically identify potential candidates for LDCT screening, reach out to them via the patient portal, and use a web app to provide them with a personalized LDCT screening decision aid and facilitate the ordering of screening tests.

Official Title
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Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Behavioral: Decision Aid Invitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has an active patient portal account Scheduled to see a Wake Forest primary care provider within the next 4 weeks Exclusion Criteria: Never smokers Current or former history of lung cancer Receipt of chest CT scan within last 12 months Need for a language interpreter Presence of disease predicting short life-expectancy

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Aid Invitation<br>Electronic invitation to complete a web-based lung cancer screening decision aid | Behavioral: Decision Aid Invitation<br>* electronic invitation to complete web-based decision aid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of LDCT screening | Number of participants who received a low-dose chest CT | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Read portal invitation | Number of participants who read the portal invitation | 120 days | 
| Visit web decision aid | Number of participants who visited the study website | 120 days | 
| Complete web decision aid | Number of participants who complete the lung cancer screening eligibility items | 120 days | 
| Eligible for LDCT | Number of participants who are confirmed eligible for LDCT by the study website | 120 days | 
| Interest in LDCT screening | Number of participants who indicate they are interested in receiving LDCT | 120 days | 
| Appointment for LDCT visit | Number of participants who are scheduled for a lung cancer screening clinic visit or a LDCT exam | 120 days |