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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

TSMVs must be 18-years of age or older

Enroll prior to military discharge

Be planning to transition from one of the target military installations' included in the evaluation during an active enrollment window

Disqualifiers

The participants Army STARRS score cannot identify the TSMV as low risk nor as acute high risk for suicide

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

2,700 Participants
are divided into 3 treatment groups
Group A: Transition as UsualNo intervention 0 interventions
Group B: Veteran Sponsorship Initiative BaseExperimental treatment 1 intervention
Group C: Veteran Sponsorship Initiative+Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Military to Civilian Questionnaire (M2C-Q; Sayer et al., 2011)

Reintegration difficulties will be assessed using the Military to Civilian Questionnaire (Primary Outcome; M2C-Q; Sayer et al., 2011), a 16-item measure that assesses reintegration difficulties in (a) interpersonal relationships with family, friends, and peers; (b) productivity at work, in school, or at home, (c) community participation; (d) self-care; (e) leisure, and (f) perceived meaning in life. Items are rated on a 5-point Likert scale ranging from 0 (No difficulty) to 4 (Extreme difficulty). Minimum: 0 (best); Maximum: 4 (worst)

Time frame
Change in baseline scores across 3 timepoints [Time frame: Baseline, 6 months post-military separation, and 12 months post-military separation]

Secondary outcomes

1

Columbia-Suicide Severity Rating Scale (C-SSRS) screener (Posner et al., 2011)

Risk for suicidal ideation and behaviors will be assessed using procedures described by Katz et al. (2019). The VA Intake team will ask questions from the Columbia-Suicide Severity Rating Scale (C-SSRS) screener (Posner et al., 2011) supplemented by questions based on cues provided in the full C-SSRS about suicide attempts ("Have you attempted suicide or done harm to yourself or put yourself in a dangerous situation with the intent of ending your life"), and about injuries ("Did it result in you needing to get medical care with a doctor or hospital"). TSMVs will be placed in hierarchical categories based on their highest level of reported ideation or behavior. Minimum: 0 (best); Maximum: 7 (worst)

Time frame
Change in baseline scores across 2 timepoints [Time Frame: Baseline and 12 months after]
2

Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003)

Depression will be assessed using the Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003), a 2-item self-report measure that has shown strong construct validity, test-retest reliability, and internal reliability across samples (Kroenke et al., 2003). A PHQ-2 score ranges from 0-6. If the score is 3 or greater, major depressive disorder is likely.

Time frame
Change in baseline scores across 3 timepoints [Time Frame: Baseline, 6 months after, and 12 months after]
3

Generalized Anxiety Disorder-2 (GAD-2; Kroenke, K. et al., 2007).

Anxiety will be assessed using the GAD-2, a 2-item self-report measure that has shown strong construct validity, test-retest reliability, and internal reliability across samples (Kroenke et al., 2007). A GAD-2 score ranges from 0-6. If the score is 3 or greater, an anxiety depressive disorder is likely.

Time frame
Change in baseline scores across 3 timepoints [Time Frame: Baseline, 6 months after, and 12 months after]
4

VA Primary Care Utilization

VA primary care utilization serves as a key indicator of access to and continuity of care, reflecting how effectively Veterans are connected to routine, preventive, and chronic disease management services. Higher or sustained primary care utilization is often associated with improved health outcomes, reduced emergency department visits, and better chronic disease management among Veterans. This will be assessed through the VA Corporate Data Warehouse (CDW), which enables us to access data for TSVMs who have enrolled and utilized VA healthcare services

Time frame
Program entry through 12 months post-discharge of the last TSMV to enroll

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

VISN 2 Mental Illness Research, Education, and Clinical Center

Collaborator

VISN 17 Center of Excellence for Research on Returning War Veterans

Collaborator

Department of War Study to Assess Risk & Resilience in Servicemembers - Longitudinal Study

Collaborator

James J. Peters Veterans Affairs Medical Center

Collaborator

Health Economics Resource Center

Collaborator