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

NCT ID: NCT02962115

Last Updated: 2022-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Decision Aid Invitation

Electronic invitation to complete a web-based lung cancer screening decision aid

Group Type EXPERIMENTAL

Decision Aid Invitation

Intervention Type BEHAVIORAL

electronic invitation to complete web-based decision aid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decision Aid Invitation

electronic invitation to complete web-based decision aid

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David P Miller, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30625501 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCCWFU 99316

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00036974

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lung Screen Uptake Trial
NCT02558101 COMPLETED NA
Early Detection of Lung Cancer
NCT03181256 ACTIVE_NOT_RECRUITING
Testing the Engaged Approach to Lung Cancer Screening
NCT06327074 ACTIVE_NOT_RECRUITING NA