Digital Outreach Intervention for Lung Cancer Screening (mPATH-Lung)

Wake Forest University (WFU)

Status: Completed

Conditions: Lung Cancer

Treatments: Other: mPATH-Lung; Other: Lung health video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04083859

1R01CA237240 (U.S. NIH Grant/Contract)

IRB00060382 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 26,998 patients

Sex: All

Ages: 50 to 77 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26,998 participants in 2 patient groups, including a placebo group

mPATH-Lung

Experimental group

Description:

Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program.

Treatment:

Other: mPATH-Lung

Usual care (CONTROL)

Placebo Comparator group

Description:

Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.

Treatment:

Other: Lung health video