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

Cancer Clinical Trial

— CORONA-SHIELD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04357574
• Other study ID #: Pro00105266
• Status: Enrolling by invitation
• Start date: April 14, 2020
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	Duke Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Oncology providers perception of of telehealth for on treatment patients in lieu of in person on treatment visits during COVID-19	survey assessment scored as strongly agree (positive perception) through strongly disagree (negative perception)	12 months
Secondary	Number of missed telehealth clinical evaluation visits during COVID-19		12 months
Secondary	Number of unplanned emergency department visits or hospital admissions during COVID-19		12 months
Secondary	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		12 months