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

Recruiting

• Conditions: Colorectal Cancer (Diagnosis); Lung Cancer Diagnosis; Prostate Cancer Diagnosis; Breast Cancer Diagnosis

• Registration Number: NCT06559059
• Lead Sponsor: NYU Langone Health

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).

Study Timeline

• Study Start: 2024-06-18
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-05-31
• Primary Completion: 2027-05-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fraction of patients engaging in at least one telehealth visit	Post-NTO implementation (up to 3 months)	Telehealth utilization among Veterans with cancer will be measured by fraction of patients engaging in at least one telehealth visit.
Number of raw telehealth visits	Post-NTO implementation (up to 3 months)	Telehealth utilization among Veterans with cancer will be measured through raw telehealth visit counts.

Secondary Outcome Measures

Name	Time	Method
Average total cost for cancer diagnosis, treatment and downstream HealthCare utilization	Post-NTO implementation (up to 3 months)
Time of consultation to time of first treatment	Pre-implementation, post-NTO implementation (up to 3 months)	Time to care will be measured through time of consultation to time of first treatment.
Change in provider level Quality Oncology Practice Initiative (QOPI) score	Pre-implementation, post-NTO implementation (up to 3 months)	The quality of care of the intervention will be evaluating utilizing the American Society of Clinical Oncology Practice Initiative (QOPI) performance measures. The scale consists of 26 performance measures assessed at the patient, provider, and facility levels. Each cancer care provider will have his or her patient QOPI measures aggregated together for a provider level QOPI score. Our primary interest is the difference in QOPI score by intervention condition, as estimated by the fixed-effect coefficient for the intervention indicator variable. Scores of 75% or more indicate the standard is met, scores less than 75% indicate the standards have not been met. An increase in the QOPI score indicates improvement.
Time of consultation to time of first appointment	Pre-implementation, post-NTO implementation (up to 3 months)	Time to care will be measured through time of consultation to time of first appointment.

Trial Locations

Locations (5)

VA New York Harbor Healthcare System - Brooklyn; 🇺🇸 Brooklyn, New York, United States

VA New York Harbor Healthcare System - St. Albans Community Living Center; 🇺🇸 Jamaica, New York, United States

VA New York Harbor Health Care System - Manhattan; 🇺🇸 New York, New York, United States

VA New York Harbor Healthcare System - Harlem Community Center; 🇺🇸 New York, New York, United States

VA New York Harbor Healthcare System - Staten Island Community Clinic; 🇺🇸 Staten Island, New York, United States