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

Официальное название

A Pragmatic Randomized-Controlled Learning Health System Trial

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• Number of Participants to Complete Lung Screening CT - Primary Effectiveness [Срок оценки: 90 days]

Вторичные конечные точки (5)

• Number of Participants with Eligibility for Lung Screening [Срок оценки: 90 days]
• Number of Requests for Lung Screening [Срок оценки: 90 days]
• Number of Orders for Lung Screening CT Scans [Срок оценки: Within 90 days of randomization]
• Amount of Revenue Generated [Срок оценки: 12 months following completion of screenings]
• Number of Participants that Represent Over-screening [Срок оценки: 90 days]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Atrium Health Wake Forest Baptist — Winston-Salem

Идентификаторы

NCT: NCT07322367 · IRB00139213 · P30CA012197

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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