Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)
17 марта 2022 г. обновлено: Lyle J. Fagnan, Oregon Health and Science University
Increasing Human Papillomavirus (HPV) Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)
The goal of this study is to engage rural primary care clinics and community organizations to test interventions designed to increase HPV vaccinations in both male and female patients aged 9-26 years.
Обзор исследования
Статус
Активный, не рекрутирующий
Условия
Вмешательство/лечение
Подробное описание
The overarching goal of this study is to engage rural primary care clinics and community organizations to test interventions designed to increase HPV vaccinations in both male and female patients aged 9-26 years.
Using a step-wedge randomized controlled trial, we will design and test the effectiveness of multi-component primary care practice-based interventions on the completion of the HPV vaccine series and will explore implementation timing in high and low functioning practices to determine how specific characteristics affect the delivery of the full series.
Additionally, we will design and test the impact of a community organization-based intervention intended to educate the public about HPV and cancer risk and risk reduction via vaccination.
Тип исследования
Интервенционный
Регистрация (Действительный)
22000
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
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Oregon
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Portland, Oregon, Соединенные Штаты, 97239
- ORPRN
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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
От 18 лет до 89 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Oregon family medicine and pediatric clinics located in rural communities that see adequate numbers of patients in the age range we are studying (age 11-17 years).
Exclusion Criteria:
- We will not include neonates, decisionally impaired adults, and prisoners in this study.
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: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Practice Facilitation, Cluster 1
Intervention Cluster 1 is the first intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
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For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
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Экспериментальный: Practice Facilitation, Cluster 2
Intervention Cluster 2 is the second intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
|
For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
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Экспериментальный: Practice Facilitation, Cluster 3
Intervention Cluster 3 is the third intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
|
For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
|
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Экспериментальный: Practice Facilitation, Cluster 4
Intervention Cluster 4 is the fourth intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
|
For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
|
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Экспериментальный: Practice Facilitation, Cluster 5
Intervention Cluster 5 is the final intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
|
For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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HPV vaccine series completion
Временное ограничение: 3 months
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A primary outcome variable is the receipt rate of the full series of HPV vaccine among males and females aged 11-17 years.
Practices will be block randomized in five waves every six months.
Outcomes will be measured every three months in all clusters at every period, so that each cluster provides data points in both the control and intervention conditions.
Practices in each wave will be stratified based on designation of pediatric or family medicine clinic to balance pediatric/family medicine clinics at each wave.
Outcome data collection will be collected from Oregon's ALERT Immunization System beginning in quarter four and up to 17, for 14 longitudinal data collection points per practice.
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3 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Lyle J Fagnan, MD, Oregon Health and Science University
- Главный следователь: Patty Carney, PhD, Oregon Health and Science University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
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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 (Действительный)
1 июня 2019 г.
Первичное завершение (Ожидаемый)
1 декабря 2022 г.
Завершение исследования (Ожидаемый)
1 июня 2023 г.
Даты регистрации исследования
Первый отправленный
11 июля 2018 г.
Впервые представлено, что соответствует критериям контроля качества
19 июля 2018 г.
Первый опубликованный (Действительный)
27 июля 2018 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
31 марта 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
17 марта 2022 г.
Последняя проверка
1 марта 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 18660
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Нет
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. .
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