- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02086565
Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults
Background: Asthma morbidity is high in inner-city minority adults, despite the existence of efficacious therapy. Tailored, patient-centered interventions are needed to improve access to care and patient-provider communication. Access and communication increasingly rely on information technology (IT) as new incentives arise to use the Electronic Health Record (EHR). The EHR patient portal (PP) gives patients web-based communication with providers and practices. How the poor and those with limited educational opportunities can take advantage of these is unclear. In contrast, the investigators have found that home visits (HVs) by community health workers (CHWs) can improve access to care for children and promote caretaker-clinician communication. The investigators also found many inner-city adults have internet access and are willing to learn to use the PP.
Objective: to examine the benefits for adults of using the PP with and without HVs by CHWs who will encourage/facilitate PP use, understand patients' social context, and enhance communication with the medical team. The investigator hypothesize all patients will benefit from PPs, and that the addition of HVs will be particularly helpful for those with low literacy or language barriers. Specific Aims test if the 1-year interventions result in 1) better within-group asthma outcomes, 2) better outcomes in one group over the other, 3) more communication (use of PP) and access (appointments made and kept) which mediate the interventions' effects on asthma outcomes, and 4) effect modification by literacy level, primary language, and convenience of internet access.
Methods: In a randomized controlled trial, 301 adults, predominantly African American and Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods will be assured internet access and taught to use the PP, with and without HVs from a CHW. CHWs will 1) train patients to competency in PP use, 2) enhance care coordination, 3) transmit a view of the complex social circumstances of patients' lives to providers, and 4) make up for differences in patients' health literacy skills.
Patient Outcomes are asthma control, asthma-related quality of life, emergency department (ED) visits, and hospitalizations for asthma or any cause. Together asthma and other health conditions affect patients' ability to perform their daily tasks and care for their families. Potential benefits of the intervention are enhanced patient-clinician communication, access to care, improved health, and ability to use IT.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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-
Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- University of Pennsylvania Health System
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- adults predominantly African American and Hispanic/Latino with uncontrolled asthma recruited from low income urban neighborhoods
Exclusion Criteria:
- severe psychiatric or cognitive problems that would make it impossible to understand and complete the protocol.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Portal training and home visits
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
|
patient portal training and home visits by CHW to coordinate care
|
|
Активный компаратор: portal training
Participants are assured internet access and taught to use the patient portal
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training in use of patient portal
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Score of Asthma Control Questionnaire
Временное ограничение: baseline and over a year
|
This is a validated test with 6 items each with Likert score 0 to 6, reflecting symptoms over the past week.
Lower score is a better outcome.
We measured change in Asthma Control Questionnaire score from baseline to at least 12 months.
|
baseline and over a year
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Asthma-related Quality of Life
Временное ограничение: baseline and over a year
|
Quality of life is a 15-item questionnaire with 7 point response scale (1-7), higher score is better quality of life.
We measured the change from baseline and over a year.
|
baseline and over a year
|
|
Emergency Department Visits
Временное ограничение: one year before baseline to one year after baseline
|
Emergency department visits for asthma from one year before baseline to one year after baseline.
|
one year before baseline to one year after baseline
|
|
Hospitalizations
Временное ограничение: Hospitalizations for asthma in the year before baseline to one year after baseline
|
Hospitalizations for asthma in the year before baseline to one year after baseline.
|
Hospitalizations for asthma in the year before baseline to one year after baseline
|
|
Prednisone Bursts
Временное ограничение: bursts at baseline and at one year
|
new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year.
|
bursts at baseline and at one year
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Andrea J Apter, MD, MSc, MA, University of Pennsylvania
Публикации и полезные ссылки
Общие публикации
- Localio AM, Klusaritz H, Morales KH, Ruggieri DG, Han X, Apter AJ. Primary language and the electronic health record patient portal: Barriers to use among Spanish-speaking adults with asthma. J Asthma. 2022 Oct;59(10):2081-2090. doi: 10.1080/02770903.2021.1989462. Epub 2021 Oct 20.
- Apter AJ, Localio AR, Morales KH, Han X, Perez L, Mullen AN, Rogers M, Klusaritz H, Howell JT, Canales MN, Bryant-Stephens T. Home visits for uncontrolled asthma among low-income adults with patient portal access. J Allergy Clin Immunol. 2019 Sep;144(3):846-853.e11. doi: 10.1016/j.jaci.2019.05.030. Epub 2019 Jun 7.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- R-1307-05218
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. .