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

Not Applicable

Completed

• Conditions: Lung Neoplasms
• Interventions: Behavioral: Decision Aid Invitation

• Registration Number: NCT02962115
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-10-19
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-11
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Has an active patient portal account
• Scheduled to see a Wake Forest primary care provider within the next 4 weeks

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decision Aid Invitation	Decision Aid Invitation	Electronic invitation to complete a web-based lung cancer screening decision aid

Primary Outcome Measures

Name	Time	Method
Receipt of LDCT screening	120 days	Number of participants who received a low-dose chest CT

Secondary Outcome Measures

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