<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04446468</url>
  </required_header>
  <id_info>
    <org_study_id>MHBC-007-19F</org_study_id>
    <nct_id>NCT04446468</nct_id>
  </id_info>
  <brief_title>Suicide Prevention Study of VA-BIC in the Veteran Population</brief_title>
  <acronym>VA-BIC RCT</acronym>
  <official_title>Prevention of Suicide in Veterans Through Brief Intervention and Contact (VA-BIC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>White River Junction Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The VA is committed to reducing suicide in the U.S. Veteran population. Over 6,000 Veterans&#xD;
      die from suicide each year, and this risk is particularly high following a psychiatric&#xD;
      hospitalization. This may be due to problems with engagement in care and poor social&#xD;
      connectedness. Although the VA has implemented tools to address Veteran suicide risk, suicide&#xD;
      after psychiatric discharge remains an ongoing problem. This has highlighted the need to&#xD;
      develop new interventions and approaches to post-discharge mental health care within the VA.&#xD;
      In response, this project is a randomized control trial of an intervention an intervention&#xD;
      called Prevention of suicide: Education, Awareness, Connection, and Engagement (PEACE). This&#xD;
      intervention is comprised of two synergistic and promising components to prevent suicide: 1)&#xD;
      a mobile mental health app, which aims to improve social connectedness after discharge; and&#xD;
      2) a manual-based intervention called the Veterans Affairs Brief Intervention and Contact&#xD;
      Program (VA-BIC), which promotes engagement in care. The overall goal of this study is to&#xD;
      determine if the PEACE intervention combined with standard discharge care reduces suicidal&#xD;
      ideation as compared to a control group receiving only standard discharge care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Suicide is a major public health concern in the U.S., and even more so in the&#xD;
      Veteran population. Furthermore, the period following psychiatric hospitalization is one of&#xD;
      the highest risk periods for suicide. Based on current evidence, some of the most important&#xD;
      contributing factors to post-hospitalization suicide risk include problems with engagement in&#xD;
      care, fragmented care, and lack of social connectedness. Other studies in civilian&#xD;
      populations have also raised similar concerns, highlighting the need to identify novel and&#xD;
      effective interventions or approaches to post-discharge mental health care.&#xD;
&#xD;
      Objectives: This project aims to 1) Identify the effect of PEACE on suicidal ideation after&#xD;
      psychiatric hospitalization, compared to standard care alone; 2) Identify the effect of PEACE&#xD;
      on social connectedness and engagement in care after psychiatric hospitalization, compared to&#xD;
      standard care alone; and 3) Compare the effect of PEACE on suicide attempts and suicide&#xD;
      deaths after psychiatric hospitalization, compared to standard care alone.&#xD;
&#xD;
      Methods: This is a single-site, assessor-blinded, randomized control trial of PEACE plus&#xD;
      standard psychiatric hospital discharge care compared to standard psychiatric hospital&#xD;
      discharge care alone. The trial will enroll up to 160 participants aged 18 years and older&#xD;
      who are being discharged from the White River Junction VA Medical Center inpatient mental&#xD;
      health unit. Participants will be randomized to either the PEACE intervention plus standard&#xD;
      psychiatric discharge care or standard psychiatric discharge care alone. Suicidal ideation,&#xD;
      hopelessness, social connectedness, engagement in care, suicide attempts, and app engagement&#xD;
      (only those randomized to PEACE) will be measured at baseline and one, three, and six months&#xD;
      post-discharge. Participants randomized to PEACE will also receive eight additional&#xD;
      intervention contacts as part of the VA-BIC protocol.&#xD;
&#xD;
      Hypothesis: Veterans receiving the PEACE intervention will report greater improvements in&#xD;
      suicidal thoughts and behaviors, hopelessness, social connectedness, and engagement in care&#xD;
      at follow-up contact visits compared to Veterans receiving standard care alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 19, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are assigned to one of two groups in parallel: PEACE plus standard psychiatric discharge care vs. standard psychiatric discharge care alone</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Beck Scale for Suicidal Ideation (BSS)</measure>
    <time_frame>Baseline to 6 Months Post-Discharge</time_frame>
    <description>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. This will be assessed at Baseline and one, three, and six months post-discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Suicide-Related Coping Scale</measure>
    <time_frame>Baseline to 6 Months Post-Discharge</time_frame>
    <description>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. Higher scores on the scale suggest better coping. This will be assessed at Baseline and one, three, and six months post-discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuity of Care</measure>
    <time_frame>Baseline to 3 Months Post-Discharge</time_frame>
    <description>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. Current literature on Veterans who were discharged from a VA inpatient mental health unit provides sufficient evidence that three aspects of continuity of care after psychiatric hospitalization (regularity of care, continuity of treatment across organizational boundaries, and intensity of treatment) are associated with improvements in overall mental health. This will be assessed at study completion and will include any care received between Baseline and three months post-discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Hopelessness Scale (BHS)</measure>
    <time_frame>Baseline to 6 Months Post-Discharge</time_frame>
    <description>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. This will be assessed at Baseline and one, three, and six months post-discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interpersonal Needs Questionnaire-15 (INQ-15)</measure>
    <time_frame>Baseline to 6 Months Post-Discharge</time_frame>
    <description>This is a 15-item self-report scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The INQ-15 has good reliability and validity in the Veteran population. Higher scores on the INQ-15 have been associated with suicide risk. This will be assessed at Baseline and one, three, and six months post-discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Baseline to 6 Months Post-Discharge</time_frame>
    <description>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. This will be assessed at Baseline and one, three, and six months post-discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>App Engagement Scale (AES)</measure>
    <time_frame>1 Month to 6 Months Post-Discharge</time_frame>
    <description>The AES is adapted from the end-user version of the Mobile Application Rating Scale (uMARS). It has been studied in patients with mental health conditions, has been shown to have good internal reliability, and is strongly related to app engagement. The scale assess four key analytic indicators of app engagement: amount, duration, breadth, and depth. This will be assessed at one, three, and six months post-discharge.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>MINI International Neuropsychiatric Interview</measure>
    <time_frame>Baseline</time_frame>
    <description>The MINI will be used to collect mental health diagnostic information. This scale has been validated against the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM). It is a short, structured diagnostic interview that, on average, takes about 15 minutes to administer. This will be administered at Baseline.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>Suicide Prevention</condition>
  <arm_group>
    <arm_group_label>PEACE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PEACE</intervention_name>
    <description>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.</description>
    <arm_group_label>PEACE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Psychiatric Hospital Discharge Care</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>PEACE</arm_group_label>
    <other_name>Standard Care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Per the unit psychiatrist, hospitalization was due to concerns about acute risk for&#xD;
             self-harm including suicidal ideation, suicide attempt, and/or admitting provider&#xD;
             deemed the patient was at imminent risk for self-harm;&#xD;
&#xD;
          -  Be a Veteran eligible to receive VA services;&#xD;
&#xD;
          -  Be able to speak English;&#xD;
&#xD;
          -  Have access to a smart phone and express willingness to download a mobile app.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent;&#xD;
&#xD;
          -  The investigators do not plan to enroll any potentially vulnerable populations&#xD;
             including prisoners, or involuntarily committed patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Natalie Riblet, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>White River Junction VA Medical Center, White River Junction, VT</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natalie Riblet, MD MPH</last_name>
    <phone>(802) 295-9363</phone>
    <phone_ext>5893</phone_ext>
    <email>Natalie.Riblet@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>White River Junction VA Medical Center, White River Junction, VT</name>
      <address>
        <city>White River Junction</city>
        <state>Vermont</state>
        <zip>05001-3833</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diane L Rivera</last_name>
      <phone>802-295-9363</phone>
      <phone_ext>5373</phone_ext>
      <email>Diana.rivera@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Joseph N Burgess, BS</last_name>
      <phone>(802) 295-9363</phone>
      <phone_ext>5394</phone_ext>
      <email>joseph.burgess@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Natalie Riblet, MD MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>34360101</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>34214935</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>35199662</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>35202942</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>35382976</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>35958652</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>36383739</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>36384820</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>36931135</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>36759108</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mental health education</keyword>
  <keyword>Clinical Trial</keyword>
  <keyword>Suicidal ideation</keyword>
  <keyword>Suicide, attempted</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicide Prevention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04446468
org study id: MHBC-007-19F
nct id: NCT04446468
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to one of two groups in parallel: PEACE plus standard psychiatric discharge care vs. standard psychiatric discharge care alone
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.
measure: Beck Scale for Suicidal Ideation (BSS)
time frame: Baseline to 6 Months Post-Discharge
description: 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. This will be assessed at Baseline and one, three, and six months post-discharge.
measure: Suicide-Related Coping Scale
time frame: Baseline to 6 Months Post-Discharge
description: 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. Higher scores on the scale suggest better coping. This will be assessed at Baseline and one, three, and six months post-discharge.
measure: Continuity of Care
time frame: Baseline to 3 Months Post-Discharge
description: 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. Current literature on Veterans who were discharged from a VA inpatient mental health unit provides sufficient evidence that three aspects of continuity of care after psychiatric hospitalization (regularity of care, continuity of treatment across organizational boundaries, and intensity of treatment) are associated with improvements in overall mental health. This will be assessed at study completion and will include any care received between Baseline and three months post-discharge.
measure: Beck Hopelessness Scale (BHS)
time frame: Baseline to 6 Months Post-Discharge
description: 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. This will be assessed at Baseline and one, three, and six months post-discharge.
measure: Interpersonal Needs Questionnaire-15 (INQ-15)
time frame: Baseline to 6 Months Post-Discharge
description: This is a 15-item self-report scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The INQ-15 has good reliability and validity in the Veteran population. Higher scores on the INQ-15 have been associated with suicide risk. This will be assessed at Baseline and one, three, and six months post-discharge.
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Baseline to 6 Months Post-Discharge
description: 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. This will be assessed at Baseline and one, three, and six months post-discharge.
measure: App Engagement Scale (AES)
time frame: 1 Month to 6 Months Post-Discharge
description: The AES is adapted from the end-user version of the Mobile Application Rating Scale (uMARS). It has been studied in patients with mental health conditions, has been shown to have good internal reliability, and is strongly related to app engagement. The scale assess four key analytic indicators of app engagement: amount, duration, breadth, and depth. This will be assessed at one, three, and six months post-discharge.
measure: MINI International Neuropsychiatric Interview
time frame: Baseline
description: The MINI will be used to collect mental health diagnostic information. This scale has been validated against the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM). It is a short, structured diagnostic interview that, on average, takes about 15 minutes to administer. This will be administered at Baseline.
arm group label: PEACE
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: PEACE
description: 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.
arm group label: PEACE
intervention type: Other
intervention name: Standard Psychiatric Hospital Discharge Care
description: 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.
arm group label: Control
arm group label: PEACE
other name: Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Natalie Riblet, MD MPH
role: Principal Investigator
affiliation: White River Junction VA Medical Center, White River Junction, VT
last name: Natalie Riblet, MD MPH
phone: (802) 295-9363
phone ext: 5893
email: Natalie.Riblet@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
citation: 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.
PMID: 34360101
citation: 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.
PMID: 34214935
citation: 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.
PMID: 35199662
citation: 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.
PMID: 35202942
citation: 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.
PMID: 35382976
citation: 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.
PMID: 35958652
citation: 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.
PMID: 36383739
citation: 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.
PMID: 36384820
citation: 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.
PMID: 36931135
citation: 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.
PMID: 36759108
responsible party type: Sponsor
mesh term: Suicide
mesh term: Suicide Prevention
sharing ipd: No