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Enrolling by invitation NCT04357574

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

Observational COVID-19 Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telehealth.
Who it may be relevant to
Registry conditions: COVID-19, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Radiation Oncology providers perception of of telehealth for on treatment patients in lieu of in person on treatment visits during COVID-19 [Time frame: 12 months]
Secondary outcome measures (3)
  • Number of missed telehealth clinical evaluation visits during COVID-19 [Time frame: 12 months]
  • Number of unplanned emergency department visits or hospital admissions during COVID-19 [Time frame: 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 [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Duke Cancer Center — Durham

Identifiers

NCT: NCT04357574 · Pro00105266

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗