Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01
28 апреля 2026 г. обновлено: David Adler, University of Rochester
Increasing Lung Cancer Screening Uptake Among Emergency Department Patients - LCS R01
This randomized clinical trial evaluates the effectiveness of text messaging and facilitated referral strategies to increase lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
This randomized clinical trial will evaluate strategies to improve lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria based on age and smoking history. Participants will be randomized using a 2 by 2 factorial design into one of four groups: basic referral, basic referral plus text messaging, facilitated referral, or facilitated referral plus text messaging.
The basic referral strategy includes verbal referral to the lung cancer screening program and primary care provider, if applicable, along with written contact information for the lung cancer screening program navigator. The facilitated referral strategy includes submission of a lung cancer screening requisition to the lung cancer screening program on behalf of the participant during the emergency department visit.
The text messaging intervention includes a series of theory informed messages designed to increase intention and motivation to complete lung cancer screening. Lung cancer screening uptake will be assessed at 120 days after enrollment using participant follow up and electronic health record review.
Тип исследования
Интервенционный
Регистрация (Оцененный)
1036
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Peter Macdowell
- Номер телефона: 585-274-1509
- Электронная почта: peter_macdowell@urmc.rochester.edu
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Age 50 - 80
- ≥ 20 pack-year smoking history
- current smoker or quit within 15 years
- English/Spanish speaking
- Registered in the Emergency Department as a patient
Exclusion Criteria:
- Non-English/Spanish
- Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
- Lack of text-capable mobile phone and/or inability to use text function
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Скрининг
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Basic Referral (enhanced control arm)
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening.
They will be verbally referred to a lung cancer screening program and their primary care provider (if they have one) to discuss lung cancer screening.
They will also be provided with written materials that include telephone contact information for the lung cancer screening program navigator.
If contacted, the LCS Program Navigator will conduct a discussion, schedule a screening CT scan at one of the 8 regional American College of Radiology-designated lung cancer screening centers and arrange clinical follow-up as needed.
|
Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable.
Written materials with contact information for the lung cancer screening program navigator are provided.
|
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Экспериментальный: Basic Referral plus Text Messaging
Participants assigned to this arm will receive the basic referral as described in the previous arm.
In addition, they will receive a series of text messages, aimed at generating intention and motivation to get lung cancer screening.
Patients will receive a total of 9 messages.
|
Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable.
Written materials with contact information for the lung cancer screening program navigator are provided.
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
|
|
Активный компаратор: Facilitated Referral
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening.
Rather than the basic referral received in the arms above, a lung cancer screening requisition form will be submitted to the lung cancer screening program on behalf of the participant during their emergency department visit.
|
A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit.
The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.
|
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Экспериментальный: Facilitated Referral plus Text Messaging
Participants assigned to this arm will receive facilitated referral plus the series of text messages described above.
Among these participants, contact with the lung cancer screening program is likely to occur after receipt of the initial text messages but prior to receipt of all text messages.
|
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit.
The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Participants Who Complete Lung Cancer Screening Within 120 Days After Enrollment
Временное ограничение: Up to 120 Days After Enrollment
|
Lung cancer screening uptake is defined as completion of a low dose computed tomography scan for lung cancer screening within 120 days after enrollment.
Screening completion will be confirmed using electronic health record review, lung cancer screening program records, or participant self report obtained during follow up.
The outcome is reported as the proportion of participants who complete screening.
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Up to 120 Days After Enrollment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Participants Who Participate in Shared Decision Making for Lung Cancer Screening Within 120 Days After Enrollment
Временное ограничение: Up to 120 Days After Enrollment
|
Participation in shared decision making is defined as documentation of a shared decision making discussion regarding lung cancer screening or participant self report of completing such a discussion within 120 days after enrollment.
The outcome is reported as the proportion of participants who participate in shared decision making.
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Up to 120 Days After Enrollment
|
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Frequency of Reported Barriers to Lung Cancer Screening at 120 Days
Временное ограничение: 120 Days After Enrollment
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Barriers to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up.
The questionnaire includes items on transportation challenges, cost concerns, scheduling difficulties, and fear of screening results.
The outcome is reported as the number and proportion of participants reporting each barrier.
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120 Days After Enrollment
|
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Acceptability of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
Временное ограничение: Up to 120 Days After Enrollment
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Acceptability is assessed using participant responses to Likert scale questionnaire items evaluating the degree to which participants find the emergency department based lung cancer screening interventions acceptable.
Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater acceptability.
The outcome is reported as summary scores based on participant responses.
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Up to 120 Days After Enrollment
|
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Appropriateness of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
Временное ограничение: 120 Days After Enrollment
|
Appropriateness is assessed using participant responses to Likert scale questionnaire items evaluating the perceived fit and relevance of emergency department based lung cancer screening interventions.
Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater perceived appropriateness.
The outcome is reported as summary scores based on participant responses.
|
120 Days After Enrollment
|
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Frequency of Reported Facilitators to Lung Cancer Screening at 120 Days
Временное ограничение: 120 Days After Enrollment
|
Facilitators to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up.
The questionnaire includes items related to factors such as access to care, health literacy, prior healthcare engagement, and presence of a primary care provider.
The outcome is reported as the number and proportion of participants reporting each facilitator.
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120 Days After Enrollment
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 марта 2027 г.
Первичное завершение (Оцененный)
1 декабря 2030 г.
Завершение исследования (Оцененный)
1 декабря 2031 г.
Даты регистрации исследования
Первый отправленный
27 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
28 апреля 2026 г.
Первый опубликованный (Действительный)
5 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
5 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
28 апреля 2026 г.
Последняя проверка
1 апреля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FP00007604
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Описание плана IPD
Undecided
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .