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临床试验/NCT07356492
NCT07356492招募中不适用

Expanding Veteran Sponsorship Initiative+ to Support High-Risk Transitioning Servicemembers and Veterans: A Precision Medicine Approach (PEC 24-113)

VA Office of Research and Development0 个研究点目标入组 2,700 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
2,700

研究概览

简要总结

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.

详细描述

Young Veterans in the U.S. are experiencing a suicide epidemic, with suicide rates for Veterans aged 18 to 34 years old more than doubling from 2001 (23.6 per 100,000) to 2021 (49.6 per 100,000; VA, 2023). In 2020, the rate of suicide among Veterans of this age group was 1.52 times higher than among older Veterans and 2.61 times higher than among same-aged non-Veterans (VA, 2022a). Notably, the risk for suicide is significantly elevated for young TSMVs during their transition from active-duty military service to civilian life. A VA Office of Mental Health and Suicide Prevention study showed that suicide rates after separation are time-dependent, with the highest suicide rates observed in the first year after discharge. These rates increased over the first 6 months and then generally peaked in the 6 to 12 months after discharge (Ravindran et al., 2020). Given the significant increase in suicide risk during this transitional period, researchers have dubbed the time between discharge and successful reintegration into civilian life as the "deadly gap" (Geraci et al., 2020a; Sokol et al., 2021) and have indicated that preventive interventions for this vulnerable population should begin prior to discharge (Vogt et al., 2020). About 200k TMSVs exit active-duty service yearly (VA, 2018).

To assist, the VSI is the first large-scale implementation of an evidence-based practice that intervenes with TSMVs prior to discharge. It attempts to reduce TSMV suicide risk by decreasing psychological pain often associated with the transition, increasing connectedness and assisting TSMVs to safely store their firearms by pairing of TSMVs with certified, volunteer, community-based sponsors (1-on-1). VSI is based on the DoW's Permanent Change of Station Sponsorship program and recommendations from the DoW's Best Practices Identified for Peer Support Programs (2011). On four III Armored Corps (US Army) military installations, TSMVs have had the opportunity, since FY2020 to complete a US Army Soldier for Life (SFL) application six months prior to their military discharge. SFL is a US Army program, separate from Army Transition Assistance Program, that facilitates access to services provided by the VA, local communities, and Veteran-friendly service organizations. When completing the SFL application, TSMVs have the option to request a VA VSI sponsor.

ETS Sponsorship (2025) is a national nonprofit organization that serves as the national operational partner for VSI, through its Onward Ops program, as part of a VA memorandum of agreement with the VHA Undersecretary for Health and is responsible for managing the process of collecting, securing and storing information provided by TSMVs from the SFL application. Within 14 days of completing the SFL application and requesting a sponsor, TSMVs participate in an intake with an Onward Ops transition coordinator to identify reintegration needs and then are matched with a best fitting sponsor based on geographical location, gender, sexual orientation, interests and desired profession. After matching, sponsors have regular contact with their TSMVs through social media, email, and monthly video or in-person meetings and help TSMVs to identify Specific-Measurable-Achievable-Relevant-Time Bound (SMART) goals related to domains of reintegration and social determinants of health (Geraci et al., 2020b). Contact continues through approximately 6 months post-discharge.

Sponsors are managed by different community partners (e.g., nonprofits, private hospitals, or county veteran service offices) across the country. These community partners are vetted by both the VA's National Center for Healthcare Advancement and Partnerships (2025) and Onward Ops. Primary responsibilities of the community partners include: (a) recruiting volunteer sponsors and ensuring they attend VA certification training (see Geraci et al., 2020b, for more information on the certification training); (b) matching TSMVs with sponsors; (c) managing sponsors' relationships with TSMVs in their local region; (d) submitting referrals to other agencies to assist TSMVs in meeting their goals and (e) accessing and monitoring TSMV progress in the initiative using a common digital dashboard, in partnership with Google Public Sector. Onward Ops attempts to balance the number of TSMVs in its program desiring a sponsor with the number of available sponsors and has shown an ability to recruit and certify the needed number of sponsors with many sponsors volunteering to work with more than one TSMV at a time.

In FY2022, VSI+ was developed by the VA Transitioning Servicemember/Veteran Suicide Prevention Center (TASC), housed at the James J. Peters VAMC and jointly supported by the VISN 2 MIRECC and VISN17 Center of Excellence. TASC, in partnership with Dr. Ronald Kessler, Dr. Brian Marx (VA National Center for PTSD) and the DoD STARRS team. VSI+ added a precision medicine approach to the original VSI, hereafter referred to as "VSI Base". The VSI+ has two key components:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究者

申办方类型
Fed
责任方
Sponsor

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