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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Primary Objective: Evaluate the real-world effectiveness of mPATH-Lung in increasing lung cancer screening rates across diverse populations.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Patient portal message first followed by up to 3 reminder text messages. |
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| Arm B | Experimental | Text message only with up to 3 reminder text messages. |
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| Arm C | Experimental | Portal message only with no reminder messages. |
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| Usual Care Arm | Active Comparator | Patients receive usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portal Message with Reminder Text Messages | Other | 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 8 days after the initial message, and potentially an 'in progress' text message reminder. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants to Complete Lung Screening CT - Primary Effectiveness | Completion of the lung screening CT by participants. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Eligibility for Lung Screening | Reach of the mPATH-Lung platform, defined as the participants who determine their eligibility for lung screening within the mPATH-Lung program within 90 days of the first invitation. Investigators will determine reach overall, within subgroups, and within study arms. | 90 days |
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Inclusion Criteria:
Eligible patients will:
Exclusion Criteria:
The following patients will be excluded:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 704-355-2000 | Aliza.randazzo@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Brent Heideman, Jr., MD | Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Text Message with Reminder Text Messages | Other | 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 message reminder. |
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| Portal message only | Other | Participant will only receive portal message with no reminder text messages. |
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| Usual Care | Other | Standard of care |
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| Number of Requests for Lung Screening |
Requests for lung screening within the mPATH-Lung program |
| 90 days |
| Number of Orders for Lung Screening CT Scans | Orders for lung screening CT scans for participants in study arms | Within 90 days of randomization |
| Amount of Revenue Generated | Revenue (costs) generated from lung cancer screening and follow-up care. | 12 months following completion of screenings |
| Number of Participants that Represent Over-screening | Among patients with newly diagnosed lung cancer by lung screening, the participants that represent over-screening, defined as a patient being deemed too ill for potentially curative surgery on blinded chart review. | 90 days |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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