- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04496713
Pilot Study of Video and Telephone Primary Care Visits
Pilot Study - Randomized Controlled Trial of Video and Telephone Primary Care Visits
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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-
Maryland
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Baltimore, Maryland, Соединенные Штаты, 21287
- Johns Hopkins Outpatient Center
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Adult patients scheduled for telephone-based visits who are doing so because of a lack of ability to conduct a video visit (i.e. no tablet/laptop; no access to internet) who live in Baltimore City
Exclusion Criteria:
- Patients with significant visual or hearing impairment
- Patients that have legal guardians or who are marked as lacking healthcare decision-making capacity
- Patients that have not selected English as their preferred language
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Telemedicine - Phone
Patients will continue with their telephone-based telemedicine visit as scheduled.
There will be no change to their care.
Patients will receive a survey by mail about the visit.
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|
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Экспериментальный: Telemedicine - Audio/Video
Patients will be given an internet-connected tablet to have their upcoming visit with their physician by audio/video.
A survey can be completed on the tablet.
The devices will be sent back to the research time after their single use.
|
An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating
Временное ограничение: Within 2 weeks of the study visit
|
Provider rating will be assessed with the Consumer Assessment of Healthcare Providers and Systems question on provider rating of 0-10; 0 being worst provider possible and 10 being best provider possible.
|
Within 2 weeks of the study visit
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Satisfaction with telemedicine visit for patient as assessed by a Likert scale
Временное ограничение: Within 2 weeks of the study visit
|
Satisfaction with telemedicine visit for patient will be assessed with Likert-scale questions related to satisfaction. Satisfaction (1=strongly disagree to 5=strongly agree).
Overall score 3 to 15 with higher scores signifying better satisfaction. |
Within 2 weeks of the study visit
|
|
Satisfaction with telemedicine visit for provider as assessed by a Likert scale
Временное ограничение: Within 2 weeks of the study visit
|
Satisfaction with telemedicine visit for provider will be assessed with Likert-scale questions related to satisfaction. [1=Strongly Disagree. 5=Strongly Agree].
Overall score 2 to 10 with higher scores signifying better satisfaction. |
Within 2 weeks of the study visit
|
|
Efficacy of telemedicine visit for provider as assessed by a Likert scale
Временное ограничение: Within 2 weeks of the study visit
|
Efficacy of telemedicine visit for provider will be assessed with Likert-scale questions related to efficacy. [1=Strongly Disagree. 5=Strongly Agree]. b. I was able to understand the patient's explanation of their medical problems well enough. c. In general, this telemedicine visit was effective in improving this patient's medical care d. An in-person visit would likely have provided additional clinically-relevant information e. An in-person visit would likely have led to a change in management |
Within 2 weeks of the study visit
|
|
Provider communication as assessed by yes/no question
Временное ограничение: Within 2 weeks of the study visit
|
The ability of a provider to communicate will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to communication. Did this provider explain things in a way that was easy to understand? Yes/No |
Within 2 weeks of the study visit
|
|
Provider listening as assessed by yes/no question
Временное ограничение: Within 2 weeks of the study visit
|
Provider listening will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to listening. Did this provider listen carefully to you? Yes/No |
Within 2 weeks of the study visit
|
|
Provider respect as assessed by yes/no question
Временное ограничение: Within 2 weeks of the study visit
|
Provider respect will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to respect. Did this provider show respect for what you had to say? Yes/No |
Within 2 weeks of the study visit
|
|
Provider time spent as assessed by yes/no question
Временное ограничение: Within 2 weeks of the study visit
|
Provider time spent will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to time spent during the clinical encounter. Did this provider spend enough time with you? Yes/No |
Within 2 weeks of the study visit
|
|
Patient health rating as assessed by a likert scale
Временное ограничение: Within 2 weeks of the study visit
|
Patient health will be assessed with Likert-scale questions related to patient health. In general, how would you rate your overall health?
In general, how would you rate your overall mental or emotional health?
Overall score 2 to 10 with lower scores signifying better health. |
Within 2 weeks of the study visit
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Jeremy A Epstein, MD, Johns Hopkins University
- Главный следователь: Casey Overby Taylor, PhD, Johns Hopkins University
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 (Действительный)
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
Другие идентификационные номера исследования
- IRB00257994
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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.
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