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

Wake Forest University (WFU)

Status: Not yet enrolling

Conditions: Lung Cancer

Treatments: Other: Usual Care; Other: Portal Message with Reminder Text Messages; Other: Portal message only; Other: Text Message with Reminder Text Messages

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07322367

P30CA012197 (U.S. NIH Grant/Contract)

IRB00139213

Details and patient eligibility

About

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.

Full 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

Enrollment: 27,000 estimated patients

Sex: All

Ages: 50 to 77 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27,000 participants in 4 patient groups

Arm A

Experimental group

Description:

Patient portal message first followed by up to 3 reminder text messages.

Treatment:

Other: Portal Message with Reminder Text Messages

Arm B

Experimental group

Description:

Text message only with up to 3 reminder text messages.

Treatment:

Other: Text Message with Reminder Text Messages

Arm C

Experimental group

Description:

Portal message only with no reminder messages.

Treatment:

Other: Portal message only

Usual Care Arm

Active Comparator group

Description:

Patients receive usual care.

Treatment:

Other: Usual Care