Clinical trial NCT04357574: Assessing the System for High-Intensity Evaluation During Radiotherapy During Changes in Response to COVID-19
Official title: Assessing the Provider Implementation and Experience of TeleHealth During COVID-19 and Impact on Acute Encounters
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COVID-19
Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2020-04-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Radiation Oncology providers perception of of telehealth for on treatment patients in lieu of in person on treatment visits during COVID-19
timeFrame: 12 months
Secondary outcomes:
measure: Number of missed telehealth clinical evaluation visits during COVID-19
timeFrame: 12 months
measure: Number of unplanned emergency department visits or hospital admissions during COVID-19
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Manisha Palta, MD
role: PRINCIPAL_INVESTIGATOR
References: