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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02962115
Collaborator
(none)
1,000
1
4.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Decision Aid Invitation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Mar 31, 2017
Actual Study Completion Date :
Mar 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Receipt of LDCT screening [120 days]

    Number of participants who received a low-dose chest CT

Secondary Outcome Measures

  1. Read portal invitation [120 days]

    Number of participants who read the portal invitation

  2. Visit web decision aid [120 days]

    Number of participants who visited the study website

  3. Complete web decision aid [120 days]

    Number of participants who complete the lung cancer screening eligibility items

  4. Eligible for LDCT [120 days]

    Number of participants who are confirmed eligible for LDCT by the study website

  5. Interest in LDCT screening [120 days]

    Number of participants who indicate they are interested in receiving LDCT

  6. Appointment for LDCT visit [120 days]

    Number of participants who are scheduled for a lung cancer screening clinic visit or a LDCT exam

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 77 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT02962115
Other Study ID Numbers:
  • IRB00036974
  • CCCWFU 99316
First Posted:
Nov 11, 2016
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2022