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
2 other identifiers
interventional
1,800
1 country
5
Brief Summary
The objective of the 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 personal characteristics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2024
CompletedFirst Submitted
Initial submission to the registry
August 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
June 3, 2026
June 1, 2026
3 years
August 15, 2024
June 1, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of raw telehealth visits
Telehealth utilization among Veterans with cancer will be measured through raw telehealth visit counts.
Post-NTO implementation (up to 3 months)
Fraction of patients engaging in at least one telehealth visit
Telehealth utilization among Veterans with cancer will be measured by fraction of patients engaging in at least one telehealth visit.
Post-NTO implementation (up to 3 months)
Secondary Outcomes (4)
Change in provider level Quality Oncology Practice Initiative (QOPI) score
Pre-implementation, post-NTO implementation (up to 3 months)
Time of consultation to time of first appointment
Pre-implementation, post-NTO implementation (up to 3 months)
Time of consultation to time of first treatment
Pre-implementation, post-NTO implementation (up to 3 months)
Average total cost for cancer diagnosis, treatment and downstream HealthCare utilization
Post-NTO implementation (up to 3 months)
Study Arms (2)
VA National TeleOncology Service (NTO)
EXPERIMENTALThis arm will include 1. Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a telehealth visit utilizing the VA National TeleOncology Service (NTO), and 2. VA health care providers and staff members participating in cancer care at NTO program medical centers.
Usual Care
NO INTERVENTIONThis arm will include 1. Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a visit at a VA medical center location that has not implemented NTO, and 2. VA health care providers and staff members participating in cancer care at a medical center where the NTO program has not been implemented.
Interventions
Medical and/or subspecialty oncology care offered via facility-to-facility telehealth as an alternative to usual in-person care at the nearest VA or community oncology care setting offering similar services.
Eligibility Criteria
You may qualify if:
- A Veteran
- Aged 18 years or older
- Newly diagnosed with lung, prostate, breast, or colon cancer within 3 months of telemedicine visit
- Engaged in an oncology visit during the 36-month analysis period at a Veterans Affairs Medical Center (VAMC) location.
- Provider or staff member at one of the VAMC locations including physicians, nurse practitioners, physicians' assistants, and nurses caring for Veterans
- Providers or staff members having helped provide care for at least 5 Veterans with cancer in the previous 6 months at a VAMC location
You may not qualify if:
- Veterans who have not seen any providers in the VA within the past year
- Patients previously diagnosed with lung, prostate, breast, or colon cancer
- Pregnant patients
- \. Providers or staff members who do not help treat Veterans with specified cancers in oncology at the VA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
VA New York Harbor Healthcare System - Brooklyn
Brooklyn, New York, 11209, United States
VA New York Harbor Healthcare System - St. Albans Community Living Center
Jamaica, New York, 11425, United States
VA New York Harbor Health Care System - Manhattan
New York, New York, 10010, United States
VA New York Harbor Healthcare System - Harlem Community Center
New York, New York, 10027, United States
VA New York Harbor Healthcare System - Staten Island Community Clinic
Staten Island, New York, 10314, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danil Makarov, MD, MHS
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2024
First Posted
August 19, 2024
Study Start
June 18, 2024
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to janeth.juarezpadilla@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data for survey and interview participants who have been consented and signed Health Insurance Portability and Accountability Act (HIPAA) waivers will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Per Veterans Health Administration (VHA) policy, the deidentified national data is unable to be shared. Requests may be directed to: janeth.juarezpadilla@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.