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

NCT07356492 | Recruiting DMC

• 2 other identifiers: PEX 25-0011I50HX003929-01
• Study Type: interventional
• Target: 2,700
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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
• Effectiveness: Evaluate the impact of VSI Base and VSI+ on reintegration difficulties, depression, anxiety, suicidal ideation/behavior, and VA utilization outcomes.
• Implementation: Assess the feasibility and fidelity of implementing VSI Base and VSI+ across multiple sites using a bundled strategy.
• Economic Impact: Estimate the budget impact of VSI Base and VSI+ on healthcare costs, including inpatient, emergency, and outpatient care.

Conditions

Reintegration Difficulties; Suicidal Ideation and Behaviors; Health; Connectedness

Keywords

Suicide; Reintegration; Social Determinants of Health; Transitioning Servicemember/Veteran; Suicide Prevention; VA Utilization; Community Intervention; Suicidal Behavior

Outcome Measures

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)

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

Secondary Outcomes (11)

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

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

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

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

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

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

• VA Primary Care Utilization

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

• VA healthcare enrollment and utilization

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

Study Arms (3)

Transition as Usual

NO INTERVENTION

Arm 1. Transition as Usual, n=900 * receives no Onward Ops services * receives no VA stepped care services

Veteran Sponsorship Initiative Base

EXPERIMENTAL

Arm 2. VSI Base, n=900 * receives Onward Ops peer sponsor and community services * receives no VA stepped care services

Behavioral: Onward Ops- receive peer sponsor and community support

Veteran Sponsorship Initiative+

EXPERIMENTAL

Arm 3. VSI+, n=900 * receives Onward Ops peer sponsor and community services * receives VA stepped care services

Behavioral: Onward Ops- receive peer sponsor and community support; Behavioral: VA stepped care services

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.

Also known as: ETS Sponsorship

Veteran Sponsorship Initiative Base; Veteran Sponsorship Initiative+

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.

Veteran Sponsorship Initiative+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• James J. Peters Veterans Affairs Medical Center: collaborator
• 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
• Health Economics Resource Center: collaborator

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

RECRUITING

Related Links

• VA Veteran Sponsorship Initiative

MeSH Terms

Conditions

Suicidal Ideation; Behavior; Suicide; Suicide Prevention

Interventions

Community Support

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Community Participation; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joseph C Geraci, PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

• Richard W Seim

  Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

  PRINCIPAL INVESTIGATOR

• Emily R Edwards, PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

• Marianne S. Goodman, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

• Brigid B Connelly, MA

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

• Erin P Finley, PhD MPH

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

• Jean Yoon, PhD MHS

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

• David E Goodrich, EdD MS MA

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph C Geraci, PhD

CONTACT

(718) 584-9000; Joseph.Geraci@va.gov

David E Goodrich, EdD MS MA

CONTACT

David.Goodrich2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Methods: The purpose of this PEI proposal is to evaluate VSI expansion into VSI+ utilizing four III Armored Corps installations (FY2026-2027). The evaluators will use a pragmatic cluster-randomized trial design. This design will allow us to extend implementation support to the maximal number of military installations and enhance our formative evaluation.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)