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

• Conditions: COVID-19; Cancer
• Interventions: Other: Telehealth

• Registration Number: NCT04357574
• Lead Sponsor: Duke University

Brief 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.

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 Timeline

• Study Start: 2020-04-14
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Radiation Oncology providers perception of of telehealth for on treatment patients in lieu of in person on treatment visits during COVID-19	12 months	survey assessment scored as strongly agree (positive perception) through strongly disagree (negative perception)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke Cancer Center; 🇺🇸 Durham, North Carolina, United States