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Recruiting NCT07322367

A Mobile Patient Health Technology Intervention for Improving Lung Cancer Screening Rates in Eligible High Risk Patients

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Portal Message with Reminder Text Messages, Text Message with Reminder Text Messages, Portal message only, Usual Care.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 50 years — 77 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pragmatic Randomized-Controlled Learning Health System Trial

Overview

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.

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

Interventions

  • 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
  • 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 me
  • Other Portal message only
    Participant will only receive portal message with no reminder text messages.
  • Other Usual Care
    Standard of care

Primary outcome measures

  • Number of Participants to Complete Lung Screening CT - Primary Effectiveness [Time frame: 90 days]
Secondary outcome measures (5)
  • Number of Participants with Eligibility for Lung Screening [Time frame: 90 days]
  • Number of Requests for Lung Screening [Time frame: 90 days]
  • Number of Orders for Lung Screening CT Scans [Time frame: Within 90 days of randomization]
  • Amount of Revenue Generated [Time frame: 12 months following completion of screenings]
  • Number of Participants that Represent Over-screening [Time frame: 90 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Screening

Study locations

United States · 1 center
  • Atrium Health Wake Forest Baptist — Winston-Salem

Identifiers

NCT: NCT07322367 · IRB00139213 · P30CA012197

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗