mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews. This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.
Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill. Secondary Objectives: * Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 50 patients. * Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
26,998
A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.
Web-based video about guideline recommended exercise for lung health
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review
Time frame: Within 16 weeks of enrollment
LCS Screening Decision
Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only
Time frame: Up to 16 weeks after day of enrollment
Proportion of Patients With LCS Clinic Visits Scheduled
The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed
Time frame: 16 weeks
Proportion of Patients With LCS Clinic Visits Completed
The proportion of patients in each arm who have completed a LCS clinic visit
Time frame: 16 weeks
Proportion of Patients With LCS Scans Ordered
The proportion of patients in each arm for whom a LCS scan was ordered
Time frame: 16 weeks
LCS Clinic Referral Requested Through mPATH
The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment.
Time frame: 16 weeks
Lung Cancer Screening Test Results
The results of a completed lung cancer screening CT, reported using the Lung-RADS classification
Time frame: 16 weeks
Number of LCS False Positives
A Lung-RADS 3 or 4 result with a negative completed work-up for lung cancer or no diagnosis of lung cancer within 12 months of the scan.
Time frame: 1 year
Invasive Procedures Following LCS Scan
The proportion of patients in each arm who undergo an invasive procedure following a LCS scan
Time frame: 1 year
Proportion of Patients With Complications Following LCS
The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan
Time frame: 1 year
Number of Diagnosed Lung Cancers
Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization
Time frame: 16 months after randomization
How Diagnosed Lung Cancers Were Detected
Proportion of patients who had lung cancers detected related to screening or incidentally.
Time frame: 16 months after randomization
Stage of Lung Cancers Diagnosed
Stage of lung cancers diagnosed
Time frame: 16 months after randomization
Overscreening
The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.
Time frame: 1 year
Reach of Digital Outreach Strategy
The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.
Time frame: 16 weeks
Completion of mPATH-Lung Program
The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision.
Time frame: 16 weeks
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