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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
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Neoplasms

Eligibility Criteria

55 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 19, 2016
    Last Updated
    February 16, 2022
    Sponsor
    Wake Forest University Health Sciences
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    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

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

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