Lung Cancer
Conditions
Brief summary
To evaluate the real-world effectiveness and implementation strategies for mPATH-Lung, investigators propose a pragmatic, randomized controlled trial across an academic Learning Health System. The trial will contrast several approaches to participant outreach and will specifically target engaging fully powered cohorts of racial/ethnic minorities and rural residents.
Detailed description
Primary Objective: Evaluate the real-world effectiveness of mPATH-Lung in increasing lung cancer screening rates across diverse populations. Secondary Objectives * Compare the differential effectiveness of three outreach strategies for engaging participants with mPATH-Lung across vulnerable rural or ethnic/racial minority population subgroups. * Estimate the additional revenue generated by mPATH-Lung through increased screening and downstream care. * Evaluate the potential for over-screening and the impact of applying HEDIS-based exclusion criteria
Interventions
OTHERPortal Message with Reminder Text Messages
If the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder if they start the mPATH-Lung program but do not complete it. If the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder.
OTHERText Message with Reminder Text Messages
If the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder. If the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder.
OTHERPortal message only
Participant will only receive portal message with no reminder text messages.
OTHERUsual Care
Standard of care
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 77 Years
Healthy volunteers
No
Inclusion criteria
Eligible patients will: * Meet the Medicare criteria for lung cancer screening, as updated in February 2022: * Age 50 - 77 years * Smoked at least 20 pack years * Current smoker or quit smoking within the past 15 years * Be established with a primary care provider within the Atrium Health Wake Forest Baptist health network (defined as having completed at least 1 primary care appointment in the past 6 months or have completed at least 2 primary care appointments within the past 18 months or being scheduled to see a health network primary care provider within the next 30 days). * Have a patient portal account or cellphone number listed in the electronic health record * Have a North Carolina address listed in the electronic health record
Exclusion criteria
The following patients will be excluded: * Patients flagged as needing a language interpreter in the electronic health record for any language other than Spanish (electronic messages and intervention are deliverable in English or Spanish only) * Those for whom lung cancer screening would be or may be inappropriate: electronic health record Prior history of lung cancer electronic health record Chest CT within the last 12 months electronic health record Those meeting the HEDIS COL-E measure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants to Complete Lung Screening CT - Primary Effectiveness | 90 days | Completion of the lung screening CT by participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Eligibility for Lung Screening | 90 days | Reach of the mPATH-Lung platform, defined as the participants who determine their eligibility for lung screening within the mPATH-Lung program within 90 days of the first invitation. Investigators will determine reach overall, within subgroups, and within study arms. |
| Number of Requests for Lung Screening | 90 days | Requests for lung screening within the mPATH-Lung program |
| Number of Orders for Lung Screening CT Scans | Within 90 days of randomization | Orders for lung screening CT scans for participants in study arms |
| Amount of Revenue Generated | 12 months following completion of screenings | Revenue (costs) generated from lung cancer screening and follow-up care. |
| Number of Participants that Represent Over-screening | 90 days | Among patients with newly diagnosed lung cancer by lung screening, the participants that represent over-screening, defined as a patient being deemed too ill for potentially curative surgery on blinded chart review. |
Countries
United States
Contacts
CONTACTStudy Coordinator
PRINCIPAL_INVESTIGATORBrent Heideman, Jr., MD
Wake Forest Baptist Comprehensive Cancer Center
Outcome results
None listed