Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
Primary Purpose
Lung Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decision Aid Invitation
Sponsored by
About this trial
This is an interventional screening trial for Lung Neoplasms
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Decision Aid Invitation
Arm Description
Electronic invitation to complete a web-based lung cancer screening decision aid
Outcomes
Primary Outcome Measures
Receipt of LDCT screening
Number of participants who received a low-dose chest CT
Secondary Outcome Measures
Read portal invitation
Number of participants who read the portal invitation
Visit web decision aid
Number of participants who visited the study website
Complete web decision aid
Number of participants who complete the lung cancer screening eligibility items
Eligible for LDCT
Number of participants who are confirmed eligible for LDCT by the study website
Interest in LDCT screening
Number of participants who indicate they are interested in receiving LDCT
Appointment for LDCT visit
Number of participants who are scheduled for a lung cancer screening clinic visit or a LDCT exam
Full Information
NCT ID
NCT02962115
First Posted
October 19, 2016
Last Updated
February 16, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02962115
Brief Title
Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
Official Title
Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision Aid Invitation
Arm Type
Experimental
Arm Description
Electronic invitation to complete a web-based lung cancer screening decision aid
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid Invitation
Intervention Description
electronic invitation to complete web-based decision aid
Primary Outcome Measure Information:
Title
Receipt of LDCT screening
Description
Number of participants who received a low-dose chest CT
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Read portal invitation
Description
Number of participants who read the portal invitation
Time Frame
120 days
Title
Visit web decision aid
Description
Number of participants who visited the study website
Time Frame
120 days
Title
Complete web decision aid
Description
Number of participants who complete the lung cancer screening eligibility items
Time Frame
120 days
Title
Eligible for LDCT
Description
Number of participants who are confirmed eligible for LDCT by the study website
Time Frame
120 days
Title
Interest in LDCT screening
Description
Number of participants who indicate they are interested in receiving LDCT
Time Frame
120 days
Title
Appointment for LDCT visit
Description
Number of participants who are scheduled for a lung cancer screening clinic visit or a LDCT exam
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Miller, MD, MS
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30625501
Citation
Dharod A, Bellinger C, Foley K, Case LD, Miller D. The Reach and Feasibility of an Interactive Lung Cancer Screening Decision Aid Delivered by Patient Portal. Appl Clin Inform. 2019 Jan;10(1):19-27. doi: 10.1055/s-0038-1676807. Epub 2019 Jan 9.
Results Reference
derived
Learn more about this trial
Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
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