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Набор по приглашению NCT04357574

Assessing the System for High-Intensity Evaluation During Radiotherapy During Changes in Response to COVID-19

Наблюдательное COVID-19 Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Telehealth.
Кому может быть актуально
Состояния в реестре: COVID-19, Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Assessing the Provider Implementation and Experience of TeleHealth During COVID-19 and Impact on Acute Encounters

Обзор

The primary objective of this research study is to assess Radiation Oncology healthcare providers (i.e. faculty, residents and advanced practice providers (APPs) implementation and perception of telehealth for on treatment patients in lieu of in person on treatment visits during standard of care radiotherapy during COVID-19.

Подробное описание

A secondary aim will be to evaluate the rates of acute care during COVID-19 with telehealth in comparison to the rates during our prior Quality Improvement (QI) project (NCT04277650), considering the risk prediction based on our previously developed ML algorithm. Patient risk during this period will be assessed by the ML algorithm and actual rates of Emergency Department visits and hospitalizations (acute encounters) will be compared to the results of our prior QI project. These data will be used to discern how actual rates of acute care compare to providers' expectations both with and without telehealth implementation. Reasons for acute encounters and associated healthcare costs compared to patients undergoing standard of care assessments in NCT04277650 will be assessed to determine the percentage that are COVID-19 related. Basic demographic, disease, location of acute care, form of clinical assessments (video, in-person, telephone, etc.), and treatment information regarding the patients will also be captured following the completion of the research project for assessment.

These endpoints will establish how our current COVID-19-based precautions impact treatment-related outcomes in patient care.

Вмешательства

  • Другое Telehealth
    patients have virtual visits with Radiation Oncology providers in lieu of in person clinic visits as a necessary response to COVID-19

Первичные конечные точки

  • Radiation Oncology providers perception of of telehealth for on treatment patients in lieu of in person on treatment visits during COVID-19 [Срок оценки: 12 months]
Вторичные конечные точки (3)
  • Number of missed telehealth clinical evaluation visits during COVID-19 [Срок оценки: 12 months]
  • Number of unplanned emergency department visits or hospital admissions during COVID-19 [Срок оценки: 12 months]
  • Number of acute care visits with listed reason as anemia, nutrition (including dehydration), diarrhea, emesis, infectious (including fever, pneumonia, and sepsis), nausea, neutropenia, pain category during COVID-19 [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • started outpatient radiation therapy with or without concurrent systemic therapy at Duke Cancer Center during the COVID-19 outbreak

Критерии исключения

  • undergoing total body radiation therapy for hematopoetic stem cell transplantation
  • undergoing therapy as inpatient
  • completed radiation therapy prior to algorithm execution

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Duke Cancer Center — Durham

Идентификаторы

NCT: NCT04357574 · Pro00105266

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗