Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

A Pragmatic Randomized-Controlled Learning Health System Trial

NCT ID: NCT07322367Sponsor: Wake Forest University Health SciencesLast updated: 2026-03-25

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

Arms & 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

Outcome measures

Primary

  • Number of Participants to Complete Lung Screening CT - Primary Effectiveness

    Completion of the lung screening CT by participants.

    Time frame: 90 days

Secondary

  • Number of Participants with Eligibility for Lung Screening

    Time frame: 90 days

  • Number of Requests for Lung Screening

    Time frame: 90 days

  • Number of Orders for Lung Screening CT Scans

    Time frame: Within 90 days of randomization

  • Amount of Revenue Generated

    Time frame: 12 months following completion of screenings

  • Number of Participants that Represent Over-screening

    Time frame: 90 days

Eligibility criteria

Sex: AllAge: 50 Years to 77 YearsHealthy 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 exclusion criteria based on significant comorbidities and/or frailty.

Study locations (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157

Recruiting
Study Coordinator, MD · Contact
704-355-2000Aliza.randazzo@advocatehealth.org
Study Coordinator · Contact
Brent Heideman, Jr., MD · Principal Investigator