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

Duke University

Status: Invitation-only

Conditions: COVID-19; Cancer

Treatments: Other: Telehealth

Study type: Observational

Funder types: Other

Identifiers

NCT04357574

Pro00105266

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

1,000 participants in 1 patient group

Radiation Oncology Providers

Description:

Faculty physicians, residents and advanced practice providers in the Radiation Oncology Department in Duke University Health System (DUHS)

Treatment:

Other: Telehealth