A Pragmatic Randomized-Controlled Learning Health System Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 27,000
- Locations
- 1
- Primary Endpoint
- Number of Participants to Complete Lung Screening CT - Primary Effectiveness
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 50 Years to 77 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Arm A
Patient portal message first followed by up to 3 reminder text messages.
Intervention: Portal Message with Reminder Text Messages (Other)
Arm B
Text message only with up to 3 reminder text messages.
Intervention: Text Message with Reminder Text Messages (Other)
Arm C
Portal message only with no reminder messages.
Intervention: Portal message only (Other)
Usual Care Arm
Patients receive usual care.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Number of Participants to Complete Lung Screening CT - Primary Effectiveness
Time Frame: 90 days
Completion of the lung screening CT by participants.
Secondary Outcomes
- Number of Participants with Eligibility for Lung Screening(90 days)
- Number of Requests for Lung Screening(90 days)
- Number of Orders for Lung Screening CT Scans(Within 90 days of randomization)
- Amount of Revenue Generated(12 months following completion of screenings)
- Number of Participants that Represent Over-screening(90 days)