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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: COVID-19; Cancer
• Intervention / Treatment: Other: Telehealth

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing radiation therapy in the Department of Radiation Oncology at Duke Cancer Center during the COVID-19 outbreak

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radiation Oncology Providers; Faculty physicians, residents and advanced practice providers in the Radiation Oncology Department in Duke University Health System (DUHS)	Other: Telehealth; patients have virtual visits with Radiation Oncology providers in lieu of in person clinic visits as a necessary response to COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of missed telehealth clinical evaluation visits during COVID-19	12 months
Number of unplanned emergency department visits or hospital admissions during COVID-19	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	12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Manisha Palta, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00105266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No