Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
Location contact
Brent Heideman, Jr., MD
PRINCIPAL_INVESTIGATOR
Study Coordinator
CONTACT
Study Coordinator, MD
CONTACT
NCT Number: NCT07322367
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.
Interested in participating?
Request Info50 year–77 year
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
Brent Heideman, Jr., MD
PRINCIPAL_INVESTIGATOR
Study Coordinator
CONTACT
Study Coordinator, MD
CONTACT
Primary Objective: Evaluate the real-world effectiveness of mPATH-Lung in increasing lung cancer screening rates across diverse populations.
Secondary Objectives
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligible patients will:
Exclusion criteria
The following patients will be excluded:
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.
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.
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.
Participant will only receive portal message with no reminder text messages.
Standard of care
Time frame: 90 days
Completion of the lung screening CT by participants.
Time frame: 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.
Time frame: 90 days
Requests for lung screening within the mPATH-Lung program
Time frame: Within 90 days of randomization
Orders for lung screening CT scans for participants in study arms
Time frame: 12 months following completion of screenings
Revenue (costs) generated from lung cancer screening and follow-up care.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
A Pragmatic Randomized-Controlled Learning Health System Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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