Expanding Veteran Sponsorship Initiative+ to Support High-Risk Transitioning Servicemembers and Veterans: A Precision Medicine Approach

Part of paid clinical trials in The Bronx, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT07356492
Status
Recruiting
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Conditions

  • Connectedness
  • Health
  • Reintegration Difficulties
  • Suicidal Ideation and Behaviors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Onward Ops- receive peer sponsor and community support — BEHAVIORAL
    Onward Ops is a nonprofit organization dedicated to supporting U.S. military service members and their families as they transition from active duty to civilian life. It provides a structured, community-based approach to help ease the challenges of reintegration. Participants may engage in either the Onward Ops Solo or Co-Op track. Both tracks provide access to the Onward Ops dashboard- an online platform to manage transition plans, track progress, and explore curated resources. In addition, Co-Op participants are matched to a community-based, peer sponsor \& receive assistance from community partners.
  • VA stepped care services — BEHAVIORAL
    The high-risk TSMVs receive approximately five sessions of VSI+ with optimally two sessions occurring prior to discharge with a TRICARE approved referral. VSI+ is delivered via telehealth video to allow flexibility and to accommodate the fact that TSMVs will be moving after discharge. The topics and tasks associated with each session involve items such as confirming TSMVs completed their VHA registration and VBA service-connected disability application, made contact with their VSI sponsor, submitted their military records to enable them to receive a VHA eligibility group, and directly connecting TSMVs to VHA primary care. Because VSI+ is designed as an adjunctive service and TSMVs may require a broad range of services and resources, the VSI+ social workers ensure ongoing communication with VSI sponsors, community partners, VHA primary care and mental health providers. TSMVs will have seamless access to the NVCC with ability to receive primary and specialty care.

Study Details

Background Young Veterans in the U.S. face a heightened risk of suicide, particularly during the first year after leaving military service-a period often referred to as the "deadly gap." Suicide rates among Veterans aged 18 to 34 have nearly doubled since 2001, and research shows that reintegration challenges during this transition are closely linked to increased suicide risk. The Veteran Sponsorship Initiative (VSI) was developed to address this critical period by connecting Transitioning Servicemembers and Veterans (TSMVs) with trained, VA-certified peer sponsors. These sponsors help TSMVs navigate civilian life and access VA care. Early evaluations show that TSMVs matched with sponsors are more likely to report lower levels of reintegration difficulties, higher levels of social support, engage in VA services and report lower rates of depression and suicide risk. This project enhances VSI by integrating predictive analytics-developed in partnership with Harvard Medical School and the DoW STARRS-LS team-to identify high-risk TSMVs before they leave the military. Those identified receive not only a sponsor but also targeted VA mental and health care services. This hybrid effectiveness-implementation study will evaluate the impact of this enhanced model (VSI+) on mental health outcomes and VA engagement among 2,700 high-risk TSMVs. Method/Design The purpose of this PEI proposal is to evaluate VSI expansion into VSI+ with enrollment occurring on four US Army installations (FY2026-2027). The study employs a pragmatic cluster-randomized trial with embedded mixed-method implementation evaluation to compare three arms: 1. Transition as Usual (TAU) 2. VSI Base= peer sponsorship and community support 3. VSI+= VSI Base plus VA stepped care services The evaluation is guided by the RE-AIM framework to assess: * Reach (enrollment rates) * Effectiveness (reintegration difficulties, depression, anxiety, suicidal ideation/behavior, and VA utilization outcomes) * Adoption (site and staff uptake) * Implementation (fidelity and feasibility) * Maintenance (sustainability) Study Aims 1. Effectiveness: Evaluate the impact of VSI Base and VSI+ on reintegration difficulties, depression, anxiety, suicidal ideation/behavior, and VA utilization outcomes. 2. Implementation: Assess the feasibility and fidelity of implementing VSI Base and VSI+ across multiple sites using a bundled strategy. 3. Economic Impact: Estimate the budget impact of VSI Base and VSI+ on healthcare costs, including inpatient, emergency, and outpatient care.

Key Dates

Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
2,700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Transition as Usual
    Arm 1. Transition as Usual, n=900 * receives no Onward Ops services * receives no VA stepped care services
  • Experimental: Veteran Sponsorship Initiative Base
    Arm 2. VSI Base, n=900 * receives Onward Ops peer sponsor and community services * receives no VA stepped care services
  • Experimental: Veteran Sponsorship Initiative+
    Arm 3. VSI+, n=900 * receives Onward Ops peer sponsor and community services * receives VA stepped care services

Primary Outcome Measure

Military to Civilian Questionnaire (M2C-Q; Sayer et al., 2011) [ Time Frame: Change in baseline scores across 3 timepoints [Time frame: Baseline, 6 months post-military separation, and 12 months post-military separation] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical Center, Bronx, NYThe BronxNew York10468-3904
Marianne S Goodman, MD
[email protected]
718-584-9000
Nicole K Bulanchuk
[email protected]
(929) 384-0584
Emily R Edwards, PhD (PRINCIPAL_INVESTIGATOR)
Joseph C Geraci, PhD (PRINCIPAL_INVESTIGATOR)
Marianne S. Goodman, MD (PRINCIPAL_INVESTIGATOR)

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James J. Peters VA Medical Center, Bronx, NY· The Bronx, NY

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