Clinical trial NCT04083859: Digital Outreach Intervention for Lung Cancer Screening
Official title: A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Mass screening
Early detection of cancer
Digital health interventions
Decision making, computer assisted
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: National Cancer Institute (NCI)
First posted: 2019-09-10
Enrollment: 26998
Sex: ALL
Minimum age (years): 50
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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 scheduled to see a primary care provider within the health network in the next 3-4 weeks
* Have a patient portal account or cellphone number listed in the electronic health record

Exclusion Criteria:

* Patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in English only).
* Those for whom lung cancer screening would be inappropriate:

  * Prior history of lung cancer
  * Chest CT within the last 12 months
  * Those with medical conditions predicting shorter life expectancy
  * Patients whose home address is not within the state of North Carolina. (Due to telehealth guidelines)

Primary outcomes:
measure: Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
timeFrame: Within 16 weeks of enrollment
Secondary outcomes:
measure: LCS Screening Decision
timeFrame: Up to 16 weeks after day of enrollment
measure: Proportion of Patients With LCS Clinic Visits Scheduled
timeFrame: 16 weeks
measure: Proportion of Patients With LCS Clinic Visits Completed
timeFrame: 16 weeks
measure: Proportion of Patients With LCS Scans Ordered
timeFrame: 16 weeks
measure: LCS Clinic Referral Requested Through mPATH
timeFrame: 16 weeks
measure: Lung Cancer Screening Test Results
timeFrame: 16 weeks
measure: Number of LCS False Positives
timeFrame: 1 year
measure: Invasive Procedures Following LCS Scan
timeFrame: 1 year
measure: Proportion of Patients With Complications Following LCS
timeFrame: 1 year
measure: Number of Diagnosed Lung Cancers
timeFrame: 16 months after randomization
measure: How Diagnosed Lung Cancers Were Detected
timeFrame: 16 months after randomization
measure: Stage of Lung Cancers Diagnosed
timeFrame: 16 months after randomization
measure: Overscreening
timeFrame: 1 year
measure: Reach of Digital Outreach Strategy
timeFrame: 16 weeks
measure: Completion of mPATH-Lung Program
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina- Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David P Miller, MD, MS
role: PRINCIPAL_INVESTIGATOR
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