跳至主要内容
临床试验/NCT05224440
NCT05224440招募中不适用

Partnered Implementation Evaluation of a National Sponsorship Program for Transitioning Service Members ( PEC 20-170)

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2022年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
630
试验地点
2
主要终点
Military to Civilian Questionnaire (M2C-Q; Sayer et al., 2011)

研究概览

简要总结

Background:

The United States is undergoing a suicide epidemic for its youngest Veterans (18-to-34-years-old) as their suicide rate has almost doubled since 2001. Veterans are at the highest risk during their first-year post-discharge, thus creating a "deadly gap" for them. In response, the nation has developed strategies that emphasize a preventive, universal and public health approach and embrace the value of community interventions. The three-step theory of suicide suggests that community interventions that reduce pain from reintegration difficulties and promote connectedness for Veterans as they transition to civilian life have the greatest likelihood of success. Recent research shows that the effectiveness of community interventions can be enhanced when augmented by volunteer and certified sponsors (1-on-1) who actively engage with Veterans, as part of the Veterans Affairs' Transitioning Servicemember/Veteran (TSMV) Sponsorship Initiative.

Method/Design:

The purpose of this trial is to determine how to implement the Veteran Sponsorship Initiative in six cities in Texas in collaboration with the US Department of Defense, VA, Texas government, and local stakeholders. Texas is an optimal location for this large-scale implementation as it has the second largest population of Veterans aged 18-to-34-years-old and is home to the largest US military installation, Fort Hood. The first aim is to further determine the effectiveness of the Sponsorship Initiative, as evidenced by measures of proximal variables (reintegration difficulties, health/psychological distress, VA healthcare utilization and connectedness) and distal variables (suicidal ideation and behaviors). The second aim is to determine how best to implement the Veteran Sponsorship Initiative in Texas with the intent of future expansion in more states. TSMVs (n=630) will be recruited from military installations six months prior to discharge and prior to moving to target cities. The evaluators are utilizing implementation strategies, such as building community partnerships and external facilitation. Evaluation will be conducted through interviews with TSMVs and periodic reflections with key stakeholders to identify barriers, facilitators, and adaptations. Outcome evaluations will be conducted with TSMVs completing surveys and data collection from working with stakeholders.

Discussion:

This evaluation will have important implications for the national implementation of community interventions that address the epidemic of TSMV suicide. Aligned with the Evidence Act, it is the first large-scale implementation of an evidence-based practice that conducts a thorough assessment of TSMVs during the "deadly gap".

详细描述

The United States is undergoing a suicide epidemic for its youngest Veterans (18-to-34-years-old) as their suicide rate has almost doubled from 23.62 suicide deaths per 100,000 in 2001 to 44.44 per 100,000 in 2019. Their current rate is 1.65 times higher than older Veterans and 2.73 times higher than non-Veterans of the same age. The approximately 200k Servicemembers that exit the active-duty military every year are at the highest risk for suicide during their first-year post-discharge as the rate almost triples during this period and remains elevated for up to six years. Therefore, the period between discharge and successfully reintegrating into civilian life is a "deadly gap". Traditional and clinical approaches offered by the VA to address the epidemic have been limited as only 24% of active-duty SMs that exit the military per year enroll in VA healthcare within the first-year post-discharge. And when servicemembers (SMs) and Veterans do seek healthcare services or are assessed for suicide risk, about 70% of them who later attempt suicide deny suicidal ideation in the months leading up to their suicide attempt.

In response, the White House developed a recent strategy that emphasizes a preventive and public health approach and embraces the value of public-private partnerships with community organizations to reduce SM and veteran suicide. Aligned with the White House's strategy, the VA has similarly implemented a public health approach that emphasizes proactive community interventions. Their intent is to implement more universal and preventive interventions that are upstream to address social determinants of health and risk factors for suicide (e.g., lack of connectedness, financial concerns/unemployment, relationship distress). Recent national legislation supports the focus on community interventions as the Commander John Scott Hannon Act will provide $174 million to organizations that provide community interventions which address suicide risk factors and engage with Veterans not participating in VA clinical care.

Klonsky and May's three-step theory of suicide (3ST) provides a theoretical basis for such preventive, universal and public health approaches to suicide that emphasize community interventions for transitioning servicemembers and Veterans (TSMVs). The primary tenants of the 3ST are that (a) suicidal ideation results from a combination of pain, primarily psychological pain, and hopelessness, (b) connectedness is a key protective factor against increasing suicidal ideation, and (c) progression from suicide ideation to attempt occurs when factors create sufficiently high capacity to end one's life.

For TSMVs, psychological pain can be attributed to reintegration difficulties. Sokol and colleagues describe how reintegration difficulties for TSMVs can be a pervasive source of pain that create the first step towards suicidal ideation. Many TSMVs report high levels of reintegration difficulties, particularly related to education/employment, housing, food security, health, relationship challenges and legal involvement. Civilian employment is often cited as a significant concern as 43 percent of SMs are not fully prepared nor career-ready as they exit the military. And as they enter the civilian workforce many TSMVs struggle to translate their military skillsets into a civilian setting with TSMVs changing jobs twice within the first three years of transition.

The reintegration difficulties that TSMVs experience can persist for over 6 years and indeed contribute to increased suicide risk. In fact, Kline and colleagues found that 45% of SMs endorse difficulties post-discharge and that those with the highest number of difficulties are at 5.42 times greater risk of suicidal ideation. Overall, it appears that reducing reintegration difficulties is likely to be a critical component of community interventions that prevent suicide.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
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,
  • be approximately 6 months from military discharge and
  • be planning to transition to one of the target cities included in the evaluation during an active enrollment window for the respective city.

排除标准

  • 未提供

研究组 & 干预措施

Transition as Usual

No Intervention

TSMVs transition to civilian life as usual.

Veteran Sponsorship Initiative

Experimental

TSMV receives a VA certified and volunteer sponsor (1-on-1) approximately 6 months prior to military discharge. Sponsorship continues for approximately 6 months after military discharge.

干预措施: Veteran Sponsorship Initiative (Behavioral)

结局指标

主要结局

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

时间窗: Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after]

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)

次要结局

  • Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006)(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2010)(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • Criminal behaviors(Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after])
  • Income status(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • Maintenance (VA funding)(Change in funding across 2 timepoints for each city [Time Frame: 12 months after initiation of evaluation for each city and 6 months after))
  • Implementation (Quality of delivery)(One timepoint [Time Frame: 12 months after Baseline])
  • Employment/education status(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • Brief Resilience Scale (BRS; Smith et al., 2008)(Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after])
  • Well-Being Signs(Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after])
  • Alcohol Use Disorders Identification Test-Consumption (AUDIT-C; Bush, et al., 1998)(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • Maintenance (number of sponsors)(Change in numbers across 2 timepoints for each city [Time Frame: 12 months after initiation of evaluation for each city and 6 months after))
  • Implementation (Participant responsiveness: Completion of "My Action Plan")(Change in percentages across 4 timepoints for each city [Time Frame: Initiation of evaluation for each city, 4 months after, 8 months after, and 12 months after])
  • VA Homelessness Screening Clinical Reminder (HSCR; Montgomery, 2014)(Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after])
  • U.S. Adult Food Security Survey Module (2012)(Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after])
  • VA healthcare enrollment and utilization(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • 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])
  • Primary Care PTSD 5 (PC-PTSD-5; Prins, et al., 2016)(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • Somatic symptom burden will be assessed by the Somatic Symptom Scale 8 (SSS-8; Gierk, et al., 2014)(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • Medical Outcomes Study Social Support Survey (MOS-SSS; Sherbourne & Stewart, 1991)(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • Reach(Change in baseline percentages across 4 timepoints for each military installation [Time Frame: Initiation of evaluation for each military installation, 4 months after, 8 months after, and 12 months after])
  • Adoption (Sponsors)(Change in baseline percentages across 4 timepoints for each city [Time Frame: Initiation of evaluation for each city, 4 months after, 8 months after, and 12 months after])
  • Maintenance (number of CICs)(Change in numbers across 2 timepoints for each city [Time Frame: 12 months after initiation of evaluation for each city and 6 months after))
  • Maintenance (number of TSMVs)(Change in numbers across 2 timepoints for each city [Time Frame: 12 months after initiation of evaluation for each city and 6 months after))
  • Level of personality functioning will be assessed by the Level of Personality Functioning Scale-Brief Form 2.0 (Weekers et al. 2018)(Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after])
  • Adoption (Community Integration Coordinators)(Change in baseline number across 4 timepoints for each city [Time Frame: Initiation of evaluation for each city, 4 months after, 8 months after, and 12 months after])

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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