Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 77 Years
Eligible Sex
All
Accepts 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 exclusion criteria based on significant comorbidities and/or frailty.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Screening
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
Patient portal message first followed by up to 3 reminder text messages.
  • Other: Portal 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.
Experimental
Arm B
Text message only with up to 3 reminder text messages.
  • Other: Text 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.
Experimental
Arm C
Portal message only with no reminder messages.
  • Other: Portal message only
    Participant will only receive portal message with no reminder text messages.
Active Comparator
Usual Care Arm
Patients receive usual care.
  • Other: Usual Care
    Standard of care

Recruiting Locations

Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
Contact:
Study Coordinator, MD
704-355-2000
Aliza.randazzo@advocatehealth.org

More Details

Status
Recruiting
Sponsor
Wake Forest University Health Sciences

Study Contact

Study Coordinator
704-355-2000
Aliza.randazzo@advocatehealth.org

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.