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| Name | Class |
|---|---|
| White River Junction Veterans Affairs Medical Center | FED |
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The VA is committed to reducing suicide in the U.S. Veteran population. Over 6,000 Veterans die from suicide each year, and this risk is particularly high following a psychiatric hospitalization. This may be due to problems with engagement in care and poor social connectedness. Although the VA has implemented tools to address Veteran suicide risk, suicide after psychiatric discharge remains an ongoing problem. This has highlighted the need to develop new interventions and approaches to post-discharge mental health care within the VA. In response, this project is a randomized control trial of an intervention an intervention called Prevention of suicide: Education, Awareness, Connection, and Engagement (PEACE). This intervention is comprised of two synergistic and promising components to prevent suicide: 1) a mobile mental health app, which aims to improve social connectedness after discharge; and 2) a manual-based intervention called the Veterans Affairs Brief Intervention and Contact Program (VA-BIC), which promotes engagement in care. The overall goal of this study is to determine if the PEACE intervention combined with standard discharge care reduces suicidal ideation as compared to a control group receiving only standard discharge care.
Background: Suicide is a major public health concern in the U.S., and even more so in the Veteran population. Furthermore, the period following psychiatric hospitalization is one of the highest risk periods for suicide. Based on current evidence, some of the most important contributing factors to post-hospitalization suicide risk include problems with engagement in care, fragmented care, and lack of social connectedness. Other studies in civilian populations have also raised similar concerns, highlighting the need to identify novel and effective interventions or approaches to post-discharge mental health care.
Objectives: This project aims to 1) Identify the effect of PEACE on suicidal ideation after psychiatric hospitalization, compared to standard care alone; 2) Identify the effect of PEACE on social connectedness and engagement in care after psychiatric hospitalization, compared to standard care alone; and 3) Compare the effect of PEACE on suicide attempts and suicide deaths after psychiatric hospitalization, compared to standard care alone.
Methods: This is a single-site, assessor-blinded, randomized control trial of PEACE plus standard psychiatric hospital discharge care compared to standard psychiatric hospital discharge care alone. The trial will enroll up to 160 participants aged 18 years and older who are being discharged from the White River Junction VA Medical Center inpatient mental health unit. Participants will be randomized to either the PEACE intervention plus standard psychiatric discharge care or standard psychiatric discharge care alone. Suicidal ideation, hopelessness, social connectedness, engagement in care, suicide attempts, and app engagement (only those randomized to PEACE) will be measured at baseline and one, three, and six months post-discharge. Participants randomized to PEACE will also receive eight additional intervention contacts as part of the VA-BIC protocol.
Hypothesis: Veterans receiving the PEACE intervention will report greater improvements in suicidal thoughts and behaviors, hopelessness, social connectedness, and engagement in care at follow-up contact visits compared to Veterans receiving standard care alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEACE | Experimental | The PEACE intervention will be delivered by a trained mental health staff member, such as a study psychologist, mental health nurse, social worker, or psychiatrist. The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide. Patients in this arm will also continue to receive standard post-discharge psychiatric care. |
|
| Control | Experimental | Those randomized to the control arm will receive standard psychiatric hospital discharge care alone. Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEACE | Behavioral | The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide. |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Scale for Suicide Ideation (BSS) | The BSS is a self-reported questionnaire that assesses severity of suicidal ideation. The BSS measures attitudes, behaviors, and plans to die by suicide. Each item on the BSS is scored on a scale from 0 to 2 and the first 19 of the 21 items are used to calculate a total score ranging from 0 - 38. The BSS has high reliability and is a valid measure of suicidal ideation. There is also evidence that the BSS is measurement invariant across time. The BSS is widely used in clinical trials, is sensitive to clinical change, and unlike most other measures of suicidal ideation, higher scores on the BSS are associated with death by suicide. While there is no established BSS cutoff score to classify suicide risk as high, low, or none, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation. | 1-month, 3-month, and 6- month post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide-Related Coping Scale (SRCS) | This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts. Each item is assessed using a 5-point Likert scale and the measure has been developed based on two studies of suicide prevention strategies conducted within Veteran populations. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. Both subscales have shown good acceptable internal consistency. The two factors are also sensitive to change over time. The score range for the entire scale is 0-68. Higher scores on the scale suggest better coping. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Riblet, MD MPH | White River Junction VA Medical Center, White River Junction, VT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| White River Junction VA Medical Center, White River Junction, VT | White River Junction | Vermont | 05001-3833 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34360101 | Background | Cornelius SL, Berry T, Goodrich AJ, Shiner B, Riblet NB. The Effect of Meteorological, Pollution, and Geographic Exposures on Death by Suicide: A Scoping Review. Int J Environ Res Public Health. 2021 Jul 23;18(15):7809. doi: 10.3390/ijerph18157809. | |
| 34214935 | Background | Riblet NB, Gottlieb DJ, Watts BV, Levis M, Shiner B. Irregular hospital discharge from acute inpatient and residential mental health treatment settings in a large integrated healthcare system. Gen Hosp Psychiatry. 2021 Sep-Oct;72:7-14. doi: 10.1016/j.genhosppsych.2021.06.009. Epub 2021 Jun 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PEACE | The PEACE intervention will be delivered by a trained mental health staff member, such as a study psychologist, mental health nurse, social worker, or psychiatrist. The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide. Patients in this arm will also continue to receive standard post-discharge psychiatric care. |
| FG001 | Control | Those randomized to the control arm will receive standard psychiatric hospital discharge care alone. Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEACE | The PEACE intervention will be delivered by a trained mental health staff member, such as a study psychologist, mental health nurse, social worker, or psychiatrist. The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide. Patients in this arm will also continue to receive standard post-discharge psychiatric care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Beck Scale for Suicide Ideation (BSS) | The BSS is a self-reported questionnaire that assesses severity of suicidal ideation. The BSS measures attitudes, behaviors, and plans to die by suicide. Each item on the BSS is scored on a scale from 0 to 2 and the first 19 of the 21 items are used to calculate a total score ranging from 0 - 38. The BSS has high reliability and is a valid measure of suicidal ideation. There is also evidence that the BSS is measurement invariant across time. The BSS is widely used in clinical trials, is sensitive to clinical change, and unlike most other measures of suicidal ideation, higher scores on the BSS are associated with death by suicide. While there is no established BSS cutoff score to classify suicide risk as high, low, or none, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation. | The number analyzed differs across follow-up periods due to loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | 1-month, 3-month, and 6- month post-discharge |
|
Baseline to end of follow-up, up to 6 months.
Because our study enrolled a high-risk group of patients, it was anticipated that patients would potentially report worsening mental health symptoms and/or problems specific to substance use. We expected that patients may experience suicidal behavior and related outcomes. In some cases, the patients would be expected to be hospitalized or treated in the emergency room for these reasons. Based on local approval from our institutional review board, we treated these events as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEACE | The PEACE intervention will be delivered by a trained mental health staff member, such as a study psychologist, mental health nurse, social worker, or psychiatrist. The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide. Patients in this arm will also continue to receive standard post-discharge psychiatric care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death due to natural causes | General disorders | Non-systematic Assessment | the death was deemed to be due to natural causes by the state medical examiner |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| non-fatal or fatal suicide attempt | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Riblet | White River Junction VA Medical Center | 8022959363 | natalie.riblet@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2021 | Jan 7, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 6, 2025 | Apr 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000092864 | Suicide Prevention |
| D059020 | Suicidal Ideation |
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Participants are assigned to one of two groups in parallel: PEACE plus standard psychiatric discharge care vs. standard psychiatric discharge care alone
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The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.
|
| Standard Psychiatric Hospital Discharge Care | Other | Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy. |
|
|
| 1-month, 3-month, and 6- month post-discharge |
| The Partners in Health Scale (PIH): Self-Management | The Partners in Health Scale measures self-management of chronic health conditions. It is a valid scale that includes 12 items. Each question is measured on a Likert scale of 0-8. Scores range from 0-96. Higher scores reflect improved engagement and self-management of chronic health conditions. | 1-month, 3-months, and 6-months post discharge |
| Beck Hopelessness Scale (BHS) | The BHS is a 20-item self-report scale that assesses hopelessness over the past seven days. Patients comment on feelings about the future, loss of motivation, and future expectations. Total scores range from 0 to 20, with higher scores suggesting more hopelessness. Higher scores on the BHS are associated with increased suicide risk. The BHS has good reliability and validity and is sensitive to change. | 1-month, 3-months and 6- months post-discharge |
| Interpersonal Needs Questionnaire-15 (INQ-15): Thwarted Belongingness | The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale. Items 7, 8, 10, 13, 14, and 15 are reverse coded. Scores on the total scale range from 15-105. The thwarted belongingness subscale includes 9 items and scores range from 9-63 with higher scores indicating worse thwarted belongingness. | 1 month, 3-months, and 6-months post discharge |
| Interpersonal Needs Questionnaire-15 (INQ-15): Perceived Burdensomeness | The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale. Items 7, 8, 10, 13, 14, and 15 are reverse coded. Scores on the total scale range from 15-105. The perceived burdensomeness subscale includes 6 items and scores range from 6-42 with higher scores indicating worse perceived burdensomeness. | 1-month, 3-months, and 6-months post discharge |
| The Multidimensional Scale of Perceived Social Support (MSPSS) | The multidimensional scale of perceived social support is a valid scale that includes 12 items that measure several perceived sources of social support including family, friends, and significant others. The score range is 1-7 with higher scores suggesting greater perceived support. | 1-month, 3-months and 6- months post-discharge |
| App Engagement Scale (AES) for Mobile Applications | The App Engagement Scale (AES) is adapted from the Mobile Application Rating Scale (uMARS) and is a valid scale. All items are rated on a 5-point scale. Scores range from 0-40 and higher scores indicate greater perceived quality of the mobile application. | 6- month post-discharge |
| Continuity of Care | There is some evidence that improved continuity of care may lead to better mental health outcomes. However, a single valid standardized measure of continuity of care for mental health has not been described in the literature. Continuity of care was measured by assessing the total number of VA outpatient mental health visits attended within the three months after discharge. | 3-months post discharge |
| Suicide Attempts: Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS includes a 7-item subscale that assesses for actual and interrupted suicide attempts. It is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors. The C-SSRS subscale was used specifically to assess the number of participants who had an actual fatal or non-fatal suicide attempt within the first 6 months post discharge. | Baseline to 6- months post-discharge |
| 35199662 | Background | Riblet NB, Gottlieb DJ, Watts BV, Levis M, Scott R, Shiner B. Is It Time for the Mental Health Field to Consider Unplanned Discharge a Key Metric of Patient Safety? J Nerv Ment Dis. 2022 Mar 1;210(3):227-230. doi: 10.1097/NMD.0000000000001425. |
| 35202942 | Background | Riblet NB, Kenneally L, Stevens S, Watts BV, Gui J, Forehand J, Cornelius S, Rousseau GS, Schwartz JC, Shiner B. A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting. Gen Hosp Psychiatry. 2022 Mar-Apr;75:68-74. doi: 10.1016/j.genhosppsych.2022.02.002. Epub 2022 Feb 18. |
| 35382976 | Background | Riblet NB, Varela M, Ashby W, Zubkoff L, Shiner B, Pogue J, Stevens SP, Wasserman D, Watts BV. Spreading a Strategy to Prevent Suicide After Psychiatric Hospitalization: Results of a Quality Improvement Spread Initiative. Jt Comm J Qual Patient Saf. 2022 Oct;48(10):503-512. doi: 10.1016/j.jcjq.2022.02.009. Epub 2022 Mar 6. |
| 35958652 | Background | Britton PC, Berrouiguet S, Riblet NB, Zhong BL. Editorial: Brief interventions in suicide prevention across the continuum of care. Front Psychiatry. 2022 Jul 26;13:976855. doi: 10.3389/fpsyt.2022.976855. eCollection 2022. No abstract available. |
| 36383739 | Background | Riblet NB, Matsunaga S, Lee Y, Young-Xu Y, Shiner B, Schnurr PP, Levis M, Watts BV. Tools to Detect Risk of Death by Suicide: A Systematic Review and Meta-Analysis. J Clin Psychiatry. 2022 Nov 16;84(1):21r14385. doi: 10.4088/JCP.21r14385. |
| 36384820 | Background | Riblet NB, Shiner B, Young-Xu Y, Watts BV. Lithium in the prevention of suicide in adults: systematic review and meta-analysis of clinical trials. BJPsych Open. 2022 Nov 17;8(6):e199. doi: 10.1192/bjo.2022.605. |
| 36931135 | Background | Riblet NB, Matsunaga S, Shiner B, Schnurr PP, Watts BV. Are suicide risk scales sensitive to change? A scoping review. J Psychiatr Res. 2023 May;161:170-178. doi: 10.1016/j.jpsychires.2023.03.007. Epub 2023 Mar 9. |
| 36759108 | Background | Riblet NBV, Watts BV. Another Reason to Quit Smoking: Results of a Prospective Study Examining Smoking, COPD, and Suicide. Chest. 2023 Feb;163(2):259-261. doi: 10.1016/j.chest.2022.10.016. No abstract available. |
| 37019069 | Background | Riblet NB, Young-Xu Y, Shiner B, Schnurr PP, Watts BV. The efficacy and safety of buprenorphine for the treatment of depression: A systematic review and meta-analysis. J Psychiatr Res. 2023 May;161:393-401. doi: 10.1016/j.jpsychires.2023.03.037. Epub 2023 Mar 30. |
| 37002596 | Background | Riblet NB, Soncrant C, Mills P, Yackel EE. Analysis of Reported Suicide Safety Events Among Veterans Who Received Treatment Through Department of Veterans Affairs-Contracted Community Care. Mil Med. 2023 Aug 29;188(9-10):e3173-e3181. doi: 10.1093/milmed/usad088. |
| 37167031 | Background | Riblet NB, Gottlieb DJ, Shiner B, Zubkoff L, Rice K, Watts BV, Rusch B. An Analysis of Irregular Discharges From Residential Treatment Programs in the Department of Veterans Affairs Health Care System. Mil Med. 2023 Nov 3;188(11-12):e3657-e3666. doi: 10.1093/milmed/usad131. |
| 37652208 | Background | Kenneally L, Stevens S, Cornelius S, Shiner B, Rice K, Park J, Watts BV, Teja N, Riblet N. Pilot randomized controlled trial of a brief strategy to prevent suicide after discharge from residential addiction treatment. J Subst Use Addict Treat. 2023 Nov;154:209156. doi: 10.1016/j.josat.2023.209156. Epub 2023 Aug 29. |
| BG001 | Control | Those randomized to the control arm will receive standard psychiatric hospital discharge care alone. Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Beck Scale for Suicide Ideation (BSS) | The BSS is a self-reported questionnaire that assesses severity of suicidal ideation. BSS scores range from 0-38. While no established cutoff score exists to delineate risk of suicide, higher scores indicate more severe suicidal ideation. Scores were calculated at baseline. | Mean | Standard Deviation | units on a scale |
|
| The Beck Scale for Hopelessness (BHS) | The BHS measures hopelessness and scores range from 0-20 with higher scores reflecting worse hopelessness. BHS scores were calculated at baseline. | Mean | Standard Deviation | units on a scale |
|
| Partners in Health Scale (PIH): Self-Management | The PIH measures self-management of their chronic health conditions. Scores range from 0-96 with higher scores indicated greater self-management and engagement. PIH scores were calculated at baseline. | Mean | Standard Deviation | units on a scale |
|
| Interpersonal Needs Questionnaire-15 (INQ-15), perceived burdensomeness | The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale. Items 7, 8, 10, 13, 14, and 15 are reverse coded. Scores on the total scale range from 15-105. The perceived burdensomeness subscale includes 6 items and scores range from 6-42 with higher scores indicating worse perceived burdensomeness. Perceived burdensomeness scores were calculated at baseline. | Mean | Standard Deviation | units on a scale |
|
| Interpersonal Needs Questionnaire-15 (INQ-15), thwarted belongingness | The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale. Items 7, 8, 10, 13, 14, and 15 are reverse coded. Scores on the total scale range from 15-105. The thwarted belongingness subscale includes 9 items and scores range from 9-63 with higher scores indicating worse thwarted belongingness. Thwarted belongingness scores were calculated at baseline. | Mean | Standard Deviation | units on a scale |
|
| The Multidimensional Scale of Perceived Social Support (MSPSS) | The MSPSS is a 12-item valid scale that assesses perceived support from family, friends and significant others. The scores on the scale range from 1-7 with higher scores suggesting greater perceived support. MSPSS scores were measured at baseline. | Mean | Standard Deviation | units on a scale |
|
| Suicide Related Coping Scale (SRCS) | The SRCS is a valid scale that includes 17 items that measure a patient's perception of their ability to cope with suicidal thoughts and behaviors. The scale includes a subscale that reports on external coping as well as another subscale that reports on internal coping. The total scores on the SRCS range from 0-68 with higher scores suggesting greater ability to cope with suicidal ideation and behavior. SRCS scores were measured at baseline. | Mean | Standard Deviation | units on a scale |
|
| MINI International Neuropsychiatric Interview: Current mental health conditions | The MINI International Neuropsychiatric Interview is a short, structured diagnostic interview that has been validated against the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders. The MINI was used to assess the sum of current mental health conditions that were present at baseline. | Mean | Standard Deviation | sum of mental health conditions |
|
| OG000 |
| PEACE |
The PEACE intervention will be delivered by a trained mental health staff member, such as a study psychologist, mental health nurse, social worker, or psychiatrist. The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide. Patients in this arm will also continue to receive standard post-discharge psychiatric care. |
| OG001 | Control | Those randomized to the control arm will receive standard psychiatric hospital discharge care alone. Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy. |
|
|
| Secondary | Suicide-Related Coping Scale (SRCS) | This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts. Each item is assessed using a 5-point Likert scale and the measure has been developed based on two studies of suicide prevention strategies conducted within Veteran populations. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. Both subscales have shown good acceptable internal consistency. The two factors are also sensitive to change over time. The score range for the entire scale is 0-68. Higher scores on the scale suggest better coping. | The number analyzed differs across follow-up periods due to loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | 1-month, 3-month, and 6- month post-discharge |
|
|
|
| Secondary | The Partners in Health Scale (PIH): Self-Management | The Partners in Health Scale measures self-management of chronic health conditions. It is a valid scale that includes 12 items. Each question is measured on a Likert scale of 0-8. Scores range from 0-96. Higher scores reflect improved engagement and self-management of chronic health conditions. | The number analyzed differs across follow-up periods due to loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | 1-month, 3-months, and 6-months post discharge |
|
|
|
| Secondary | Beck Hopelessness Scale (BHS) | The BHS is a 20-item self-report scale that assesses hopelessness over the past seven days. Patients comment on feelings about the future, loss of motivation, and future expectations. Total scores range from 0 to 20, with higher scores suggesting more hopelessness. Higher scores on the BHS are associated with increased suicide risk. The BHS has good reliability and validity and is sensitive to change. | The number analyzed differs across follow-up periods due to loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | 1-month, 3-months and 6- months post-discharge |
|
|
|
| Secondary | Interpersonal Needs Questionnaire-15 (INQ-15): Thwarted Belongingness | The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale. Items 7, 8, 10, 13, 14, and 15 are reverse coded. Scores on the total scale range from 15-105. The thwarted belongingness subscale includes 9 items and scores range from 9-63 with higher scores indicating worse thwarted belongingness. | The number analyzed differs across follow-up periods due to loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | 1 month, 3-months, and 6-months post discharge |
|
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| Secondary | Interpersonal Needs Questionnaire-15 (INQ-15): Perceived Burdensomeness | The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale. Items 7, 8, 10, 13, 14, and 15 are reverse coded. Scores on the total scale range from 15-105. The perceived burdensomeness subscale includes 6 items and scores range from 6-42 with higher scores indicating worse perceived burdensomeness. | The number analyzed differs across follow-up periods due to loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | 1-month, 3-months, and 6-months post discharge |
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| Secondary | The Multidimensional Scale of Perceived Social Support (MSPSS) | The multidimensional scale of perceived social support is a valid scale that includes 12 items that measure several perceived sources of social support including family, friends, and significant others. The score range is 1-7 with higher scores suggesting greater perceived support. | The number analyzed differs across follow-up periods due to loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | 1-month, 3-months and 6- months post-discharge |
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| Secondary | App Engagement Scale (AES) for Mobile Applications | The App Engagement Scale (AES) is adapted from the Mobile Application Rating Scale (uMARS) and is a valid scale. All items are rated on a 5-point scale. Scores range from 0-40 and higher scores indicate greater perceived quality of the mobile application. | The app that was planned to be used for this study was available in the public domain when designing the study, but became non-functional during the course of the study. Thus participants were unable to access the app. The participants therefore did not answer the questions on the AES scale because they could not comment on the quality of the mobile application as they did not access the app. | Posted | 6- month post-discharge |
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| Secondary | Continuity of Care | There is some evidence that improved continuity of care may lead to better mental health outcomes. However, a single valid standardized measure of continuity of care for mental health has not been described in the literature. Continuity of care was measured by assessing the total number of VA outpatient mental health visits attended within the three months after discharge. | Posted | Mean | Standard Deviation | mental health visits attended | 3-months post discharge |
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| Secondary | Suicide Attempts: Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS includes a 7-item subscale that assesses for actual and interrupted suicide attempts. It is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors. The C-SSRS subscale was used specifically to assess the number of participants who had an actual fatal or non-fatal suicide attempt within the first 6 months post discharge. | Posted | Count of Participants | Participants | Baseline to 6- months post-discharge |
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| 2 |
| 46 |
| 1 |
| 46 |
| 18 |
| 46 |
| EG001 | Control | Those randomized to the control arm will receive standard psychiatric hospital discharge care alone. Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy. | 0 | 46 | 0 | 46 | 15 | 46 |
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| Suicidal behavior (preparatory or planning behaviors, interrupted attempt, or self-aborted attempt) | Psychiatric disorders | Systematic Assessment |
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| worsening mental health symptoms | Psychiatric disorders | Non-systematic Assessment | worsening mental health symptoms (e.g. anxiety) that were self-reported to study staff (either interventionist or assessor) during the course of the study. |
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Not provided
Not provided
Not provided
| 3 months post discharge |
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| 6 months post discharge |
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| 3 months post discharge |
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| 6 months post discharge |
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| 3 months post discharge |
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| 6 months post discharge |
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| 3 months post discharge |
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| 6 months post discharge |
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| 3 months post discharge |
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| 6 months post discharge |
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| 3 months post discharge |
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| 6 months post discharge |
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