Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization (CoSMMO)
The goal of this interventional study is to create and test a comprehensive and low burden text message program within existing Community Health Centers (CHC) electronic records system to encourage patients to complete at home colorectal cancer (CRC) screening and to make sure they get follow-up care if their results are abnormal.
First, the investigators will learn from clinic staff and patients what their needs and preferences are in terms of use of technology. This information will be used to design the text messages program.
- Clinic patients will participate in focus groups
- Clinic staff will participate in interviews
Second, the investigators will test a series of different message versions in two batches (experiments):
- Clinic patients with orders for an at-home colorectal cancer screening kit will receive the different message versions.
- In the first batch, the messages that get the most engagement from patients will be selected to be used in the second experiment.
- In the second batch, the investigators will test which messages lead to the most colorectal cancer screening completion.
- This will be rolled-out within the clinics existing electronic record system. The study team will not receive any information that will identify individual patients.
Lastly, the investigators will check again with clinic staff to learn how the program performed, and what would be needed to continue using the text message program in the long run.
-Clinic staff will participate in interviews and surveys.
Обзор исследования
Статус
Условия
Вмешательство/лечение
- Поведенческий: Message Framing Text Message
- Другой: Data Reporting and Visualization System Tools
- Поведенческий: Screening Concerns Text Message
- Поведенческий: Personalized Text Message
- Поведенческий: Live Support Outreach
- Поведенческий: Impediments Support Outreach
- Поведенческий: Autonomy Support Outreach
Подробное описание
This trial is studying optimization of text messages and outreach approaches by community health centers to increase patients' completion of FIT colon cancer screening tests. Text message reminders are a low cost, scalable way to deliver patient reminders that are low burden for staff. The proposed work uses a creative, community-engaged, systems-level approach to improve completion of FIT testing and abnormal follow-up and program sustainment in CHCs.
The study design includes three parts. First, the text messages will be optimized to maximize patient engagement and outreach (Aims 1 & 2). The study will enroll patients from three partnering CHCs to participate in six focus groups to inform message design. The investigators will also conduct key informant interviews with 5-15 staff per CHC regarding the logistics of ensuring seamless integration into routine clinical operations and perspectives on the intervention activities. Then, a factorial experiment will be conducted, assigning 2,000 patients who have received a stool-based screening kit to different reminder messages. Engagement will be measured as replies or use of ≥1 links, to indicate interaction with the message. The experiment will compare: (1) personalization; (2) concern or negative emotions about screening; and (3) gain framing. In the factorial design patients will not be individually enrolled, this intervention will be tested within the workflows of usual practice. All data for the factorial experiment will be de-identified.
With those tools in place, the investigators will optimize outreach strategies for CRC screening completion. In a second factorial experiment with 5,100 patients, the investigators will optimize outreach strategy for primary screening outcomes of home-based stool screening test completion and screening completion by any guideline-recommended CRC screening test. Secondary outcomes include follow-up care for abnormal stool test results. In this factorial experiment, the investigators will test the impact of three outreach conditions on screening completion: increasing patient autonomy, providing information for accessing resources for impediments to care, and provision of live support. As in the first factorial test, for the second factorial test patients will not be individually enrolled, as the intervention will be tested within the workflows of usual practice. All data will be de-identified.
Finally, the study will assess implementation outcomes and sustainment of intervention components and effects. The investigators will conduct staff interviews and surveys to assess organizational capacity for sustaining the intervention elements being tested as well as the acceptability and feasibility of the text messages and screening tools. Sustainment of the text message outreach intervention elements will be assessed at post intervention and two 6-month intervals post-intervention.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Yamila Sierra
- Номер телефона: 303-724-4811
- Электронная почта: yamila.sierra@cuanschutz.edu
Места учебы
-
-
Massachusetts
-
Boston, Massachusetts, Соединенные Штаты, 02114
- Massachusetts General Hospital
-
Контакт:
- Stephanie Martinez, MPH
- Номер телефона: 617-643-4995
- Электронная почта: smartinez7@mgb.org
-
Младший исследователь:
- Adjoa Anyane-Yeboa, MD, MPH
-
Boston, Massachusetts, Соединенные Штаты, 02215
- Dana Farber Cancer Institute
-
Контакт:
- Soumya Mohanty, MBBS, MD, MPH
- Номер телефона: 857-263-9746
- Электронная почта: soumya_mohanty@dfci.harvard.edu
-
Младший исследователь:
- Kasisomayajula Viswanath, PhD
-
Boston, Massachusetts, Соединенные Штаты, 02108
- The Massachusetts League of Community Health Center, Inc.
-
Контакт:
- Susan Dargon-Hart, LICSW
- Номер телефона: 617-877-6535
- Электронная почта: sdargonhart@massleague.org
-
Главный следователь:
- Susan Dargon-Hart
-
-
Texas
-
Dallas, Texas, Соединенные Штаты, 75390
- University of Texas Southwestern Medical Center
-
Контакт:
- Lynn N Ibekwe-Agunanna, PhD, MPH
- Номер телефона: 214-645-2532
- Электронная почта: Lynn.Ibekwe-Agunanna@utsouthwestern.edu
-
Младший исследователь:
- Lynn Ibekwe-Agunanna, MPH, PhD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Eligibility Criteria for CHC Patients Cohorts
Inclusion Criteria (CHC Patients):
- Adults 45-75 years old
- Receive care in partner CHCs
- Are of average risk for colorectal cancer
- Received a stool-based testing order at their CHC
- Have a mobile phone and can receive text messages (Aim 1 quantitative cohort only)
- Fluent in English, Spanish, or another predominant language to be identified by the PI (applicable to patients focus groups cohort only)
Exclusion Criteria (CHC Patients):
- Personal or family history of CRC or colorectal polyps
- History of inflammatory bowel disease
- Heritable conditions that put them at above average risk for colorectal cancer (e.g., familial adenomatous polyposis)
Eligibility Criteria for CHC Staff Cohorts Inclusion Criteria (CHC Staff)
- Adult employees of participating CHCs
- Job responsibilities include activities related to CRC screening
Exclusion Criteria (CHC Staff)
- None
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Standard Message - Gain Frame
No personalization, no concerns/negative emotion, gain-framed message.
|
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
|
|
Экспериментальный: Concern Message - Gain Frame
No personalization, screening concerns/negative emotions, gain-framed message.
|
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Emotional concerns or barriers related to CRC screening.
|
|
Экспериментальный: Concern Message - No Gain Frame
No personalization, screening concerns/negative emotions, no gain-framed message.
|
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Emotional concerns or barriers related to CRC screening.
|
|
Экспериментальный: Standard Message - No Gain Frame
No personalization, no screening concerns/negative emotions, no gain-framed message.
|
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
|
|
Экспериментальный: Personalized Message - Gain Frame
Personalization included, no screening concerns/negative emotions, gain-framed message.
|
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Message includes personalized content.
|
|
Экспериментальный: Personalized Message - No Gain Frame
Personalization included, no screening concerns/negative emotions, no gain-framed message.
|
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Message includes personalized content.
|
|
Экспериментальный: Personalized - Concern Message - Gain Frame
Personalization and screening concerns/negative emotions, gain framed message.
|
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Emotional concerns or barriers related to CRC screening.
|
|
Экспериментальный: Personalized - Concern Message - No Gain Frame
Personalization and screening concerns/negative emotions, no gain-framed message.
|
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Emotional concerns or barriers related to CRC screening.
|
|
Экспериментальный: Basic Outreach Only
No autonomy support, no impediments support, no live support.
|
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
|
|
Экспериментальный: Outreach + Impediments Support
No autonomy support, no live support.
Impediment support.
|
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Include information or resources to help overcome barriers to care.
|
|
Экспериментальный: Outreach + Impediments + Live Support
No autonomy support.
Impediment support and live support included.
|
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
Include information or resources to help overcome barriers to care.
|
|
Экспериментальный: Outreach + Live Support
Live support included.
No autonomy or impediments support.
|
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
|
|
Экспериментальный: Autonomy Outreach Support
Autonomy support included, no impediments or live support.
|
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Provide patients with choices or options to increase sense of control.
|
|
Экспериментальный: Autonomy + Live Support
Autonomy and live support with impediments support.
|
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
Provide patients with choices or options to increase sense of control.
|
|
Экспериментальный: Autonomy + Impediments Support
Autonomy and impediments support included.
No live support included.
|
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Include information or resources to help overcome barriers to care.
Provide patients with choices or options to increase sense of control.
|
|
Экспериментальный: Autonomy + Impediments + Live Support
Autonomy, impediments, and live support included.
|
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
Include information or resources to help overcome barriers to care.
Provide patients with choices or options to increase sense of control.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Text message engagement
Временное ограничение: 14 days after reminder message delivery
|
Proportion of message recipients who interact with CRC screening reminder messages by reply
|
14 days after reminder message delivery
|
|
Stool-based CRC screening completion
Временное ограничение: 3 months after reminder message delivery
|
Proportion of message recipients with stool-based CRC screening tests resulted in electronic health record
|
3 months after reminder message delivery
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time to follow-up care after abnormal stool-based screening test
Временное ограничение: 3 months after date of abnormal result
|
Time (days) to follow-up care after abnormal stool-based screening test
|
3 months after date of abnormal result
|
|
Invalid test results
Временное ограничение: 3 months after reminder message delivery
|
Proportion of message recipients with invalid stool-based screening test result
|
3 months after reminder message delivery
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Gina Kruse, MD, University of Colorado, Denver
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Кишечные заболевания
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Новообразования кишечника
- Заболевания прямой кишки
- Заболевания толстой кишки
- Колоректальные новообразования
- Следственные методы
- Методы
- Research Design
Другие идентификационные номера исследования
- 25-1144.cc
- R01CA293501 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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. .