Health Clinical Trial
Official title:
Partnered Implementation Evaluation of a National Sponsorship Program for Transitioning Service Members ( PEC 20-170)
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 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 Sponsorship Initiative in Texas with the intent of future expansion in more states. TSMVs (n=628) 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".
Status | Recruiting |
Enrollment | 628 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: N/A |
Country | Name | City | State |
---|---|---|---|
United States | James J. Peters VA Medical Center, Bronx, NY | Bronx | New York |
United States | Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX | Waco | Texas |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Central Texas Veterans Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Employment/education status | Employment/education status will be assessed by asking TSMVs to self-report if they are currently enrolled as a student in any educational institute, and their current work status. If they are not a student nor employed, then the TSMV is asked "What have you been doing in the past 4 weeks to find work?". | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Brief Resilience Scale (BRS; Smith et al., 2008) | Resilience will be assessed using the Brief Resilience Scale (BRS; Smith et al., 2008), a 6-item scale with strong evidence of validity, test-retest reliability, and internal consistency across samples (Windle et al., 2011). One of the questions is: "I tend to bounce back quickly after hard times". Items are rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Minimum:1 (worst); Maximum: 5 (best) | Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after] | |
Secondary | VA Homelessness Screening Clinical Reminder (HSCR; Montgomery, 2014) | Homelessness will be assessed using the VA Homelessness Screening Clinical Reminder (HSCR; Montgomery, 2014), a four-item measure that assesses current homelessness or imminent risk of homelessness among Veterans. The HSCR is considered a standard of care within VA settings to identify and respond to instances of Veteran homelessness. One of the questions is: "In the past two months, have you been living in stable housing that you own, rent, or stay in as part of a household?" A "No" response indicates the TSMV is positive for homelessness. | Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after] | |
Secondary | U.S. Adult Food Security Survey Module (2012) | Food insecurity will be assessed using the U.S. Adult Food Security Survey Module (2012), a three-stage screening measure for assessing food insecurity. An example question is: "Within the past 12 months, the food that I bought just didn't last, and I didn't have money to get more". A response of "often" or "sometimes" is an indication that the TSMV is experiencing food insecurity. | Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after] | |
Secondary | Criminal behaviors | Criminal behaviors are assessed using a series of self-report items, including "Within the last 12 months have you been issued a ticket of any kind for a traffic violation (e.g., speeding, failure to signal)?"; "Within the last 12 months have you been arrested or charged for any type of criminal offense (e.g., DUI, disorderly conduct, drug offense, domestic violence, assault, robbery)?"; and "Within the last 12 months, has a restraining order, no contact agreement, or order of protection been initiated or taken against you?" | Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after] | |
Secondary | Well-Being Signs | Well-Being Signs is a three-item screening measure, based on the work of Vogt et al. (2021) used to assess how TSMVs are doing in their daily lives. It asks TSMVs to rate what percentage of time (from 0 to 100%) that they have been "Fully satisfied with how things are going in these aspects of life?", "Regularly involved in all aspects of life that are important to you?", and "Functioning your best in aspects of life that you do participate in?". Minimum: 0% (worst); Maximum: 100% (best) | Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after] | |
Secondary | VA healthcare enrollment and utilization | VA healthcare enrollment and utilization 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. Vanneman et al. (2015) conducted one of the first studies to identify predictors of VA enrollment and utilization for TSMVs. Importantly, they identified that there was a three-fold increase in VA enrollment and utilization during the first-year post-discharge for TSMVs who engaged in VA healthcare services prior to discharge. Therefore, this evaluation will begin the enrollment process early for TSMVs while they are still within the military. | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006) | Symptoms of anxiety will be assessed using the Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006). The GAD-7 is a 7-item self-report scale routinely used in primary care settings as a psychometrically sound screener for clinically significant anxiety (Jordan et al., 2017). Minimum: 0 (best); Maximum: 21 (worst) | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2010) | Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2010), a 9-item self-report measure that has shown strong construct validity, test-retest reliability, and internal reliability across samples (Kroenke et al., 2010; Corson et al., 2004; Currier et al., 2015). Minimum: 0 (best); Maximum: 27 (worst) | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Primary Care PTSD 5 (PC-PTSD-5; Prins, et al., 2016) | Symptoms of posttraumatic stress will be assessed using the Primary Care PTSD 5 (PC-PTSD-5; Prins, et al., 2016), a brief, self-report scale that shows excellent utility as a psychometrically sound screener for clinically significant posttraumatic stress disorder in military Veterans (Prins et al., 2016). Minimum: 0 (best); Maximum: 5 (worst) | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Alcohol Use Disorders Identification Test-Consumption (AUDIT-C; Bush, et al., 1998) | At-risk drinking behaviors will be assessed using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C; Bush, et al., 1998), a three-item, psychometrically strong, screening measure for alcohol misuse. The AUDIT-C is routinely used within VA settings to screen outpatients for at-risk drinking behaviors. Minimum: 0 (best); Maximum: 12 (worst) | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Somatic symptom burden will be assessed by the Somatic Symptom Scale 8 (SSS-8; Gierk, et al., 2014) | Somatic symptom burden related to stomach problems, back pain, headaches, chest pain, dizziness, energy, and sleep will be assessed by the Somatic Symptom Scale 8 (SSS-8; Gierk, et al., 2014). Previous studies with Veterans demonstrated good item characteristics and excellent reliability, a sound factor structure and significant associations with related constructs like depression, anxiety, pain, quality of life and impairment (Toussaint et al., 2017) | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Medical Outcomes Study Social Support Survey (MOS-SSS; Sherbourne & Stewart, 1991) | Connectedness will be assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS; Sherbourne & Stewart, 1991), a 19-item self-report measure of perceived availability of social support or connectedness that has demonstrated strong psychometric properties in military (Erbes et al., 2017), Veteran (Currier et al., 2013; Tsai et al., 2020), and civilian samples (Sherbourne & Stewart, 1991). Minimum: 1 (worst); Maximum: 5 (best) | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | 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) | Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after] | |
Secondary | Reach | Reach will be assessed by calculating the percent of eligible TSMVs that sign up for the Sponsorship Initiative compared to the total number of eligible TSMVs on respective military installations. | 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] | |
Secondary | Adoption (Sponsors) | Adoption will be assessed by the percent of sponsors who sign up for the Sponsorship Initiative and then become certified. | 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] | |
Secondary | Maintenance (number of sponsors) | Maintenance (number of sponsors) will be evaluated after the implementation phase and operationalized as the number of sponsors engaged with the sponsorship initiative. | Change in numbers across 2 timepoints for each city [Time Frame: 12 months after initiation of evaluation for each city and 6 months after) | |
Secondary | Income status | Income status will be assessed by asking TSMVs to self-report total combined income, including spouse and family, and the amount of money they have set aside in case of an unexpected financial events. | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Maintenance (number of CICs) | Maintenance (number of CICs) will be evaluated after the implementation phase and operationalized as the number of CICs engaged with the sponsorship initiative. | Change in numbers across 2 timepoints for each city [Time Frame: 12 months after initiation of evaluation for each city and 6 months after) | |
Secondary | Maintenance (number of TSMVs) | Maintenance (number of TSMVs) will be evaluated after the implementation phase and operationalized as the number of TSMVs engaged with the sponsorship initiative. | Change in numbers across 2 timepoints for each city [Time Frame: 12 months after initiation of evaluation for each city and 6 months after) | |
Secondary | Maintenance (VA funding) | Maintenance (VA funding) will be evaluated after the implementation phase and operationalized as the amount of funding dedicated to the sustainment and expansion of the sponsorship initiative. | Change in funding across 2 timepoints for each city [Time Frame: 12 months after initiation of evaluation for each city and 6 months after) | |
Secondary | Implementation (Quality of delivery) | Implementation (Quality of delivery). TSMV evaluation of sponsor through the Leader-Behavior-Description-Questionnaire-LBDQ (Halpin, 1957). | One timepoint [Time Frame: 12 months after Baseline] | |
Secondary | Level of personality functioning will be assessed by the Level of Personality Functioning Scale-Brief Form 2.0 (Weekers et al. 2018) | Level of personality functioning will be assessed by the Level of Personality Functioning Scale-Brief Form 2.0 (Weekers et al. 2018), which serves as a quick assessment of personality dysfunction severity as defined by Criterion A of the DSM-5 Alternative Model for Personality Disorders. It captures features of self-pathology, including poor self-worth and affective instability, which have close relationships with self-reported suicidality (Bach et al., 2020). | Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after] | |
Secondary | Implementation (Participant responsiveness: Completion of "My Action Plan") | Implementation (Participant responsiveness: Completion of "My Action Plan"). Will be measured by the percent of the initial "My Action Plan" completed by TSMVs with their sponsors. | 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] | |
Secondary | Adoption (Community Integration Coordinators) | Adoption (Community Integration Coordinators) will be calculated by the number of CICs who become actively involved and sign a VA Memorandum of Agreement. | 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] |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03601715 -
Analysis of Human Tissue Temperature After Application of Therapeutic Modalities.
|
N/A | |
Completed |
NCT02145273 -
Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children
|
N/A | |
Recruiting |
NCT01985152 -
A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT00970398 -
Effect of an Infant Formula on Infant Growth, Health and Immune Functions
|
N/A | |
Completed |
NCT00332137 -
Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
|
Phase 2 | |
Recruiting |
NCT06060379 -
Giochiamo 626 - Gaming for Health and Safety in Workplaces
|
N/A | |
Completed |
NCT04998266 -
Evaluation of Physical Capacities Within the Company and Effect of a Personalized Versus Traditional Training Program on the Quality of Life of Sedentary Employees
|
N/A | |
Completed |
NCT01214278 -
Bioavailability of Different n-3 Fatty Acid Formulations
|
Phase 4 | |
Recruiting |
NCT06157346 -
Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude
|
||
Completed |
NCT01057368 -
The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation
|
N/A | |
Completed |
NCT01216605 -
Oxytocin and Emotion Recognition
|
Phase 4 | |
Completed |
NCT02287441 -
Feasibility Study to Increase Vegetable Consumption
|
N/A | |
Completed |
NCT01762553 -
TEA for Families and Children: A Randomized Intervention Trial
|
N/A | |
Completed |
NCT01123772 -
Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers
|
Phase 1 | |
Completed |
NCT03527654 -
SER Hispano Longitudinal Study
|
||
Recruiting |
NCT02132741 -
Optical Coherence Tomography And NEphropathy: The OCTANE Study
|
||
Completed |
NCT03414346 -
Analysis of the Effects on Human Tissues After Application of Therapeutic Modalities.
|
N/A | |
Completed |
NCT02116283 -
Mobile Sensing of Smoking Behavior
|
N/A | |
Completed |
NCT05104385 -
Hacettepe University COVID-19 Vaccinated's Health Cohort- Students of Health Sciences
|
||
Completed |
NCT00962195 -
The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure
|
N/A |