Clinical trial NCT06559059: Evaluating the Implementation of a Comprehensive Multilevel Virtual Oncology Program Among Veterans Diagnosed With Lung, Colorectal, Prostate, and Breast Cancers in the US Department of Veterans Affairs
Official title: Evaluating the Implementation of a Comprehensive Multilevel Virtual Oncology Program Among Veterans Diagnosed With Lung, Colorectal, Prostate, and Breast Cancers in the US Department of Veterans Affairs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Diagnosis
Colorectal Cancer (Diagnosis)
Prostate Cancer Diagnosis
Breast Cancer Diagnosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-08-19
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans aged 18 years or older newly diagnosed with lung, colorectal, prostate or breast cancer.

VA health care providers and staff members participating in cancer care at NTO program medical centers, including physicians, nurse practitioners, physicians' assistants and nurses.

Brief summary: The purpose this pragmatic trial to test the effectiveness of an existing, ongoing clinical service, the VA National TeleOncology program (NTO), a multilevel telehealth population health management program. The primary aims are to study the intervention and determine its effectiveness on telehealth engagement, clinical quality, and healthcare cost outcomes across levels of Social Determinants of TeleHealth (SDTH) with the goal of promoting health equity.

Detailed description: Study staff will use the Veterans Health Information Systems and Technology Architecture (VistA), the VA health information technology system, to identify eligible patients at VA sites based on listed inclusion and exclusion criteria. Patient records will be observed of Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a telehealth visit utilizing the VA National TeleOncology Service (NTO).

Eligibility criteria: Patients Inclusion Criteria:

1. A Veteran
2. Aged 18 years or older
3. Newly diagnosed with lung, prostate, breast, or colon cancer within 3 months of telemedicine visit
4. Engaged in an oncology visit during the 36-month analysis period at a Veterans Affairs Medical Center (VAMC) location.

VAMC Providers and Staff Inclusion Criteria:

1. Provider or staff member at one of the VAMC locations including physicians, nurse practitioners, physicians' assistants, and nurses caring for Veterans
2. Providers or staff members having helped provide care for at least 5 Veterans with cancer in the previous 6 months at a VAMC location

Patients Exclusion Criteria:

1. Veterans who have not seen any providers in the VA within the past year
2. Patients previously diagnosed with lung, prostate, breast, or colon cancer
3. Pregnant patients

VAMC Providers and Staff Exclusion Criteria:

1. Providers or staff members who do not help treat Veterans with specified cancers in oncology at the VA

Primary outcomes:
measure: Number of raw telehealth visits
timeFrame: Post-NTO implementation (up to 3 months)
measure: Fraction of patients engaging in at least one telehealth visit
timeFrame: Post-NTO implementation (up to 3 months)
Secondary outcomes:
measure: Change in provider level Quality Oncology Practice Initiative (QOPI) score
timeFrame: Pre-implementation, post-NTO implementation (up to 3 months)
measure: Time of consultation to time of first appointment
timeFrame: Pre-implementation, post-NTO implementation (up to 3 months)
measure: Time of consultation to time of first treatment
timeFrame: Pre-implementation, post-NTO implementation (up to 3 months)
measure: Average total cost for cancer diagnosis, treatment and downstream HealthCare utilization
timeFrame: Post-NTO implementation (up to 3 months)
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: VA New York Harbor Healthcare System - Brooklyn
state: New York
city: Jamaica
country: United States
facility: VA New York Harbor Healthcare System - St. Albans Community Living Center
state: New York
city: New York
country: United States
facility: VA New York Harbor Health Care System - Manhattan
state: New York
city: New York
country: United States
facility: VA New York Harbor Healthcare System - Harlem Community Center
state: New York
city: Staten Island
country: United States
facility: VA New York Harbor Healthcare System - Staten Island Community Clinic
state: New York
Study officials:
affiliation: NYU Langone Health
name: Danil Makarov, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: