Trial Outcomes & Findings for Suicide Prevention Study of VA-BIC in the Veteran Population (NCT NCT04446468)
NCT ID: NCT04446468
Last Updated: 2026-01-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
1-month, 3-month, and 6- month post-discharge
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
33
|
35
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suicide Prevention Study of VA-BIC in the Veteran Population
Baseline characteristics by cohort
| Measure |
PEACE
n=46 Participants
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
n=46 Participants
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.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.33 years
STANDARD_DEVIATION 15.66 • n=158 Participants
|
46.52 years
STANDARD_DEVIATION 13.93 • n=157 Participants
|
48.42 years
STANDARD_DEVIATION 14.86 • n=315 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=158 Participants
|
10 Participants
n=157 Participants
|
14 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=158 Participants
|
36 Participants
n=157 Participants
|
78 Participants
n=315 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=158 Participants
|
40 Participants
n=157 Participants
|
83 Participants
n=315 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
5 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=158 Participants
|
43 Participants
n=157 Participants
|
87 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Beck Scale for Suicide Ideation (BSS)
|
13.80 units on a scale
STANDARD_DEVIATION 10.75 • n=158 Participants
|
13.59 units on a scale
STANDARD_DEVIATION 9.44 • n=157 Participants
|
13.70 units on a scale
STANDARD_DEVIATION 10.06 • n=315 Participants
|
|
The Beck Scale for Hopelessness (BHS)
|
10.72 units on a scale
STANDARD_DEVIATION 6.31 • n=158 Participants
|
11.04 units on a scale
STANDARD_DEVIATION 5.79 • n=157 Participants
|
10.88 units on a scale
STANDARD_DEVIATION 6.02 • n=315 Participants
|
|
Partners in Health Scale (PIH): Self-Management
|
60.83 units on a scale
STANDARD_DEVIATION 15.42 • n=158 Participants
|
59.89 units on a scale
STANDARD_DEVIATION 13.26 • n=157 Participants
|
60.36 units on a scale
STANDARD_DEVIATION 14.31 • n=315 Participants
|
|
Interpersonal Needs Questionnaire-15 (INQ-15), perceived burdensomeness
|
20.61 units on a scale
STANDARD_DEVIATION 10.58 • n=158 Participants
|
20.30 units on a scale
STANDARD_DEVIATION 10.50 • n=157 Participants
|
20.46 units on a scale
STANDARD_DEVIATION 10.48 • n=315 Participants
|
|
Interpersonal Needs Questionnaire-15 (INQ-15), thwarted belongingness
|
39.52 units on a scale
STANDARD_DEVIATION 11.40 • n=158 Participants
|
38.04 units on a scale
STANDARD_DEVIATION 12.42 • n=157 Participants
|
38.78 units on a scale
STANDARD_DEVIATION 11.87 • n=315 Participants
|
|
The Multidimensional Scale of Perceived Social Support (MSPSS)
|
4.16 units on a scale
STANDARD_DEVIATION 1.68 • n=158 Participants
|
4.51 units on a scale
STANDARD_DEVIATION 1.52 • n=157 Participants
|
4.33 units on a scale
STANDARD_DEVIATION 1.60 • n=315 Participants
|
|
Suicide Related Coping Scale (SRCS)
|
44.30 units on a scale
STANDARD_DEVIATION 12.62 • n=158 Participants
|
46.48 units on a scale
STANDARD_DEVIATION 11.18 • n=157 Participants
|
45.39 units on a scale
STANDARD_DEVIATION 11.90 • n=315 Participants
|
|
MINI International Neuropsychiatric Interview: Current mental health conditions
|
2.9 sum of mental health conditions
STANDARD_DEVIATION 0.9 • n=158 Participants
|
2.6 sum of mental health conditions
STANDARD_DEVIATION 0.9 • n=157 Participants
|
2.73 sum of mental health conditions
STANDARD_DEVIATION 0.9 • n=315 Participants
|
PRIMARY outcome
Timeframe: 1-month, 3-month, and 6- month post-dischargePopulation: The number analyzed differs across follow-up periods due to loss to follow-up.
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.
Outcome measures
| Measure |
PEACE
n=36 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Beck Scale for Suicide Ideation (BSS)
1 month post discharge
|
7.8 units on a scale
Standard Deviation 8.75
|
7.61 units on a scale
Standard Deviation 9.13
|
|
Beck Scale for Suicide Ideation (BSS)
3 month post discharge
|
9.21 units on a scale
Standard Deviation 8.64
|
6.78 units on a scale
Standard Deviation 8.49
|
|
Beck Scale for Suicide Ideation (BSS)
6 month post discharge
|
8.03 units on a scale
Standard Deviation 9.88
|
5.71 units on a scale
Standard Deviation 8.78
|
SECONDARY outcome
Timeframe: 1-month, 3-month, and 6- month post-dischargePopulation: The number analyzed differs across follow-up periods due to loss to follow-up.
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.
Outcome measures
| Measure |
PEACE
n=36 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Suicide-Related Coping Scale (SRCS)
1 month post discharge
|
52.86 units on a scale
Standard Deviation 9.82
|
53.21 units on a scale
Standard Deviation 9.88
|
|
Suicide-Related Coping Scale (SRCS)
3 months post discharge
|
52.47 units on a scale
Standard Deviation 9.33
|
53.39 units on a scale
Standard Deviation 11.16
|
|
Suicide-Related Coping Scale (SRCS)
6 months post discharge
|
52.94 units on a scale
Standard Deviation 11.82
|
56.44 units on a scale
Standard Deviation 10.25
|
SECONDARY outcome
Timeframe: 1-month, 3-months, and 6-months post dischargePopulation: The number analyzed differs across follow-up periods due to loss to follow-up.
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.
Outcome measures
| Measure |
PEACE
n=36 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
The Partners in Health Scale (PIH): Self-Management
1 month post discharge
|
73.25 units on a scale
Standard Deviation 14.70
|
73.29 units on a scale
Standard Deviation 12.27
|
|
The Partners in Health Scale (PIH): Self-Management
3 months post discharge
|
71.0 units on a scale
Standard Deviation 14.34
|
73.19 units on a scale
Standard Deviation 12.03
|
|
The Partners in Health Scale (PIH): Self-Management
6 months post discharge
|
73.97 units on a scale
Standard Deviation 12.71
|
75.94 units on a scale
Standard Deviation 12.55
|
SECONDARY outcome
Timeframe: 1-month, 3-months and 6- months post-dischargePopulation: The number analyzed differs across follow-up periods due to loss to follow-up.
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.
Outcome measures
| Measure |
PEACE
n=36 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Beck Hopelessness Scale (BHS)
1 month post discharge
|
8.19 units on a scale
Standard Deviation 5.96
|
7.66 units on a scale
Standard Deviation 6.19
|
|
Beck Hopelessness Scale (BHS)
3 months post discharge
|
9.0 units on a scale
Standard Deviation 6.0
|
6.57 units on a scale
Standard Deviation 5.06
|
|
Beck Hopelessness Scale (BHS)
6 months post discharge
|
8.0 units on a scale
Standard Deviation 5.65
|
5.57 units on a scale
Standard Deviation 5.22
|
SECONDARY outcome
Timeframe: 1 month, 3-months, and 6-months post dischargePopulation: The number analyzed differs across follow-up periods due to loss to follow-up.
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.
Outcome measures
| Measure |
PEACE
n=36 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Interpersonal Needs Questionnaire-15 (INQ-15): Thwarted Belongingness
6 months post discharge
|
32.52 units on a scale
Standard Deviation 13.56
|
25.79 units on a scale
Standard Deviation 12.09
|
|
Interpersonal Needs Questionnaire-15 (INQ-15): Thwarted Belongingness
1 month post discharge
|
31.47 units on a scale
Standard Deviation 12.64
|
28.45 units on a scale
Standard Deviation 13.43
|
|
Interpersonal Needs Questionnaire-15 (INQ-15): Thwarted Belongingness
3 months post discharge
|
33.85 units on a scale
Standard Deviation 14.07
|
30.81 units on a scale
Standard Deviation 14.81
|
SECONDARY outcome
Timeframe: 1-month, 3-months, and 6-months post dischargePopulation: The number analyzed differs across follow-up periods due to loss to follow-up.
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.
Outcome measures
| Measure |
PEACE
n=36 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Interpersonal Needs Questionnaire-15 (INQ-15): Perceived Burdensomeness
1 month post discharge
|
15.03 units on a scale
Standard Deviation 9.64
|
13.68 units on a scale
Standard Deviation 8.82
|
|
Interpersonal Needs Questionnaire-15 (INQ-15): Perceived Burdensomeness
3 months post discharge
|
14.53 units on a scale
Standard Deviation 8.20
|
13.78 units on a scale
Standard Deviation 8.82
|
|
Interpersonal Needs Questionnaire-15 (INQ-15): Perceived Burdensomeness
6 months post discharge
|
13.18 units on a scale
Standard Deviation 7.54
|
11.5 units on a scale
Standard Deviation 8.15
|
SECONDARY outcome
Timeframe: 1-month, 3-months and 6- months post-dischargePopulation: The number analyzed differs across follow-up periods due to loss to follow-up.
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.
Outcome measures
| Measure |
PEACE
n=36 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
The Multidimensional Scale of Perceived Social Support (MSPSS)
1 month post discharge
|
4.85 units on a scale
Standard Deviation 1.57
|
5.16 units on a scale
Standard Deviation 1.42
|
|
The Multidimensional Scale of Perceived Social Support (MSPSS)
3 months post discharge
|
4.69 units on a scale
Standard Deviation 1.70
|
4.66 units on a scale
Standard Deviation 2.0
|
|
The Multidimensional Scale of Perceived Social Support (MSPSS)
6 months post discharge
|
4.87 units on a scale
Standard Deviation 1.59
|
5.33 units on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: 6- month post-dischargePopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3-months post dischargeThere 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.
Outcome measures
| Measure |
PEACE
n=46 Participants
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
n=46 Participants
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.
|
|---|---|---|
|
Continuity of Care
|
14.32 mental health visits attended
Standard Deviation 12.14
|
14.15 mental health visits attended
Standard Deviation 10.31
|
SECONDARY outcome
Timeframe: Baseline to 6- months post-dischargeThe 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.
Outcome measures
| Measure |
PEACE
n=46 Participants
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
n=46 Participants
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.
|
|---|---|---|
|
Suicide Attempts: Columbia Suicide Severity Rating Scale (C-SSRS)
|
3 Participants
|
3 Participants
|
Adverse Events
PEACE
Serious events: 1 serious events
Other events: 18 other events
Deaths: 2 deaths
Control
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEACE
n=46 participants at risk
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
n=46 participants at risk
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.
|
|---|---|---|
|
General disorders
death due to natural causes
|
2.2%
1/46 • 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.
|
0.00%
0/46 • 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.
|
Other adverse events
| Measure |
PEACE
n=46 participants at risk
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
n=46 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
non-fatal or fatal suicide attempt
|
6.5%
3/46 • 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.
|
6.5%
3/46 • 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.
|
|
Psychiatric disorders
Suicidal behavior (preparatory or planning behaviors, interrupted attempt, or self-aborted attempt)
|
4.3%
2/46 • 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.
|
6.5%
3/46 • 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.
|
|
Psychiatric disorders
worsening mental health symptoms
|
30.4%
14/46 • 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.
|
23.9%
11/46 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place