Development and Pilot Testing of a Clinical Informatics L... | NCT02962115

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

NCT02962115

Sponsor

Wake Forest University Health Sciences

Status

Completed

Last Update Posted

Feb 17, 2022Actual

Enrollment

1,000Actual

Phase

Not Applicable

Conditions

Lung Neoplasms

Interventions

Decision Aid Invitation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CCCWFU 99316	Other Identifier	Wake Forest Baptist Comprehensive Cancer Center

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Mar 31, 2017Actual

Completion Date

Mar 31, 2017Actual

First Submitted Date

Oct 19, 2016

First Submission Date that Met QC Criteria

Nov 8, 2016

First Posted Date

Nov 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2022

Last Update Posted Date

Feb 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Decision Aid Invitation	Experimental	Electronic invitation to complete a web-based lung cancer screening decision aid	Behavioral: Decision Aid Invitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decision Aid Invitation	Behavioral	electronic invitation to complete web-based decision aid	Decision Aid Invitation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Read portal invitation	Number of participants who read the portal invitation	120 days
Visit web decision aid	Number of participants who visited the study website

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

77 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David P Miller, MD, MS	Wake Forest University Health Sciences	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30625501	Derived	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.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms