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

February 16, 2022 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: David P Miller, MD, MS, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00036974
  • CCCWFU 99316 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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