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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962115
• Other study ID #: IRB00036974
• Secondary ID: CCCWFU 99316
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: February 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Behavioral:
• Decision Aid Invitation
electronic invitation to complete web-based decision aid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of LDCT screening	Number of participants who received a low-dose chest CT	120 days
Secondary	Read portal invitation	Number of participants who read the portal invitation	120 days
Secondary	Visit web decision aid	Number of participants who visited the study website	120 days
Secondary	Complete web decision aid	Number of participants who complete the lung cancer screening eligibility items	120 days
Secondary	Eligible for LDCT	Number of participants who are confirmed eligible for LDCT by the study website	120 days
Secondary	Interest in LDCT screening	Number of participants who indicate they are interested in receiving LDCT	120 days
Secondary	Appointment for LDCT visit	Number of participants who are scheduled for a lung cancer screening clinic visit or a LDCT exam	120 days