Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios
Phase: NA
Conditions: Suicidal and Self-injurious Behavior
Sponsor: White River Junction Veterans Affairs Medical Center

Study Protocol 
Title: Suicide Prevention in Rural Veterans During High-risk Care Transition 
Scenarios 
NCT04054947 
 
Date of Document: 11/06/2019 

1 
Protocol version date: 11/6/2019 
 
 
Research Protocol/Protocol Addendum Template 
 
Title 
Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios 
Investigators  
Brian Shiner, MD, MPH is the Principal Investigator of this study.  
Natalie Riblet, MD, MPH is the project lead. 
Specific Aims/Purpose 
The overall goal of our proposed work is to develop and implement an effective suicide prevention intervention for 
rural VA facilities to decrease suicide risk in veterans living in rural settings. To achieve this goal, we propose to 
study our VA adaptation of the World Health Organization Brief Intervention and Contact Program (WHO BIC) 
(which we will refer to as VA BIC) in rural veterans during high-risk care transition scenarios. Please see the VA 
BIC Manual for a full description of the intervention (Appendix 1). We will study the effectiveness of VA BIC in four 
high-risk care transition scenarios common to rural VA facilities: 1) any patient being discharged from an inpatient 
mental health unit, 2) patients being discharged an inpatient medical unit after receiving a psychiatric consultation, 
3) any patient discharged from a residential substance treatment facility, and 4) patients being discharged from an 
emergency room after presenting with a mental health concern. By evaluating the intervention in each of these 
four scenarios, we will be able to guide rural VA facilities to the target populations most likely to benefit from the 
VA BIC intervention. We are initially requesting approval to conduct the VA BIC clinical trial enrolling patients from 
the first high-risk care transition scenario (any patient being discharged from an inpatient mental health unit). Once 
we reach our enrollment goal, we will submit a protocol amendment for the subsequent high-risk care transition 
scenarios. Because the VA BIC Manual may be adapted throughout the trial to target each transition scenario, 
completing a protocol amendment for each enrollment phase will be most logical and effective. 
In Year 1, we plan to confirm our pilot findings suggesting that VA BIC is effective in reducing suicide risk after 
psychiatric hospitalization by conducting a small, randomized trial of VA BIC plus standard care versus standard 
care alone on the White River Junction (WRJ) VA Medical Center (VAMC) inpatient mental health unit (see 
Preliminary Studies section below). In addition, we plan to further adapt VA BIC for veterans experiencing three 
other high-risk care transition scenarios described above. During Years 2 and 3, we will sequentially conduct  
randomized trials of VA BIC plus standard care versus standard care alone for the other three high-risk care 
transition scenarios. If our findings indicate that VA BIC is an effective intervention in one or more of these high-
risk care transition scenarios, we will spend Year 4 working with three other rural facilities to develop materials for 
dissemination of VA BIC and assisting them with implementation at their sites. These materials would be used for 
broad dissemination in future work. Based on both our pilot work with the VA BIC and the results of the original 
international WHO BIC study, we are highly confident that our intervention will be helpful for rural VA facilities in 
decreasing suicide risk in at least one of the high-risk care transition scenarios. However, we feel that taking the 
preliminary steps in Years 1-3 will result in the most practical and effective program for rural VA facilities in Year 4. 
Because of our promising pilot work,1 we believe it is appropriate to choose suicidal ideation as our primary 
outcome. In our pilot study, which included nine Veterans undergoing the VA BIC intervention, we found a 
greater than five-point improvement in the Beck Scale for Suicidal Ideation (BSS) over the three months 
following inpatient mental health discharge. Five points is a clinically meaningful improvement on the BSS as it 
represents the mean difference in suicidal ideation between ambulatory and hospitalized psychiatric patients.2 
Furthermore, with this sample size and level of improvement, we were able to demonstrate a significant 
difference in improvement in suicidal ideation compared to a matched group of historical controls participating 
in a post-mental health discharge qualitative study.3 Therefore, we believe that we will have sufficient power to 
show a clinically meaningful improvement in suicidal ideation overall and for each of the four high-risk care 
transition scenarios at one and three months after discharge if we enroll a total of 100 veterans (25 per 
transition scenario) over 3 years. We will also assess other important measures of suicide risk including 
hopelessness, connectedness, fatal/non-fatal suicide attempts and treatment engagement.4-7 Please see the 
Assessment Manual for all assessment templates (see Appendix 2). We will assess post-discharge treatment 
engagement by evaluating continuity of care and disruptions of care (including missed appointments). We will 
abstract these data from the electronic medical record. In addition, we will ask veterans to report on any 
treatment they may have received outside of the VA healthcare system. We will use a standardized data 

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Protocol version date: 11/6/2019 
 
collection form to collect information on non-VA treatment. We have already piloted this data collection form in 
our current pilot study. We will include three measures of continuity of care including intensity of treatment, 
regularity of care, and continuity of care across organizational boundaries. These measures of continuity of 
care have been shown to be associated with improved mental health outcomes.8 Because the focus of our 
project is on generating practical clinical results for rural VA facilities rapidly and cost-effectively, we will limit 
our longitudinal assessment to these outcomes. Finally, travel to appointments is a notable concern for 
veterans living in rural areas. We will give patients the choice to participate in VA BIC contact visits in-person, 
by telephone or via VA Video Connect. This approach aligns with the VA’s goal to expand the use of telehealth 
services. 
 
 
Study Objectives 
1) To adapt the VA BIC for use during high-risk care transition scenarios including emergency 
room care, medical hospitalization and acute treatment in a drug dependence rehabilitation 
program. 
2) To confirm that the VA BIC is effective at reducing suicidal ideation and other related 
measures of suicide risk during high-risk care transition scenarios including psychiatric 
hospitalization, emergency room care, medical hospitalization and residential substance 
treatment facility. 
3) To disseminate the VA BIC to other rural VA facilities and assist these facilities with 
implementing VA BIC at their local sites in order to reduce the burden of suicide in rural 
veterans during high-risk transition care scenarios. 
 
Our specific aims and hypotheses are as follows. 
Specific Aim 1: The primary aim of the study is to determine whether the VA BIC program plus standard 
discharge care reduces suicidal ideation after discharge from an acute care setting compared to standard 
discharge care, alone.   
Hypothesis: Based on available evidence, we hypothesize that the VA BIC program plus standard 
discharge care will lead to a significant reduction in suicidal ideation after discharge from an acute care 
setting.  We believe that the effect of VA BIC on suicidal ideation will be the greatest at the three-month 
follow-up because the greatest intensity of follow-up care provided through VA BIC occurs within the 
first three months after discharge.  
  
Specific Aim 2:  The secondary aim of our study is to determine the effect of the VA BIC program on other 
related measures of suicide risk.   
Hypothesis: Based on available evidence, we hypothesize that the VA BIC program plus standard 
discharge care will reduce hopelessness and improve patient engagement and perceived 
connectedness after discharge compared to standard discharge care.   
 
Specific Aim 3 (exploratory): We plan to conduct an exploratory analysis on the number of suicide 
attempts (fatal and non-fatal) that occur after discharge in the VA BIC plus standard discharge care arm 
compared to standard discharge care alone.   
 
Scientific Rationale and Significance  
 
Suicide is a major public health concern.9 U.S. veterans account for a sizable proportion of all U.S. 
suicide deaths, with approximately 14% of suicide deaths in the U.S. each year being attributed to a veteran.10-
11 The rate of suicide in the veteran population is more than two times that of non-Veteran U.S. adults.9,11 The 
average number of suicides in veterans who use VA services has risen from four suicides per day in 2001 to 
six per day in 2015. 9,11 Veterans who live in rural areas may be at even higher risk for suicide than their urban 
counterparts.12-13 For example, McCarthy et al reported that the risk for suicide among veterans in rural areas 
was 22% higher than those in urban areas.13 There is a critical need to develop targeted interventions to 
address suicide risk in veterans in rural areas. 
 
In order to have the greatest impact on suicide in rural veterans, it is important to develop effective 
interventions that target periods of highest risk. Available evidence indicates that suicide risk is most 

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Protocol version date: 11/6/2019 
 
concentrated during high-risk care transition scenarios such as discharge from an inpatient mental health 
unit or emergency room.14-18 For example, in a study of psychiatrically hospitalized male veterans, Britton et al. 
(2017) found that patients who lived in a rural setting were at 20% higher risk of suicide after discharge 
compared to urban patients.17 Similarly, patients who are discharged from an emergency room after presenting 
with suicidal behavior have a high risk for suicide in the months following discharge.18 Yet, despite this known 
risk, patients discharged from an emergency room setting (after suicidal behavior) have very high rates of non-
adherence with post-discharge care (ranging as high as 70%).18 There is also some evidence to suggest that a 
subset of patients are at increased risk for suicide after medical hospitalization.19-24 For example, Riblet et al. 
(2018) found a three-times higher risk of death by suicide among veterans with an against medical advice 
(AMA) discharge from a VA general medical ward, compared to those discharged routinely from the same 
wards.20 This underscores the importance of looking beyond typical mental health settings, as AMA discharges 
from general medical wards occur most frequently among Veterans with substance abuse and mental health 
problems.25 Finally, a substance use disorder is a strong risk for suicide and substance use disorders are 
highly prevalent in the veteran population.26-27 Bohnert et al. (2017) found that male veterans who were 
diagnosed with a substance use disorder were at nearly two times greater risk for suicide, even after adjusting 
for age and medical and psychiatric comorbidity.28 Studies have suggested that engagement in treatment (or 
lack thereof) plays an important role in clinical outcomes in veterans with substance use disorder. In particular, 
poorer continuity of care after discharge from VA residential substance treatment facilities may negatively 
impact patient engagement in care and outcomes.29-30 This observation is particularly important given that rural 
veterans in general face more challenges accessing substance abuse treatment.27 Our own recent review of 
root-cause analysis (RCA) reports of suicides following discharge from a VA residential substance treatment 
facilities (2002 – 2015) found that RCA teams reported contributing factors to suicide after discharge include 
poor engagement in care and fragmented care.31 
 
Several brief interventions have been developed to address the risk for suicide following psychiatric and 
emergency room discharge.32-33 In a meta-analysis of randomized controlled trials (RCTs) of suicide prevention 
strategies, Riblet et al. (2017) identified a single intervention, the World Health Organization Brief Intervention 
and Contact (WHO BIC) Program, that is proven to prevent suicide following psychiatric discharge.32 The WHO 
BIC (1) facilitates patient engagement through educating patients about suicide risk and (2) provides patients 
with regularly- scheduled professional support after discharge by helping patients adhere to their discharge 
care plan through in-person and telephone contact.34 The WHO BIC also aims to ensure continuity of care after 
discharge by facilitating the communication of emergent patient needs and concerns to their outpatient 
providers. Yet, the WHO BIC has not been studied in high-income countries or in U.S. veterans. Our pilot work 
demonstrated that the WHO BIC may address systematic vulnerabilities in the discharge process and align 
with hospitalized veterans’ preferences for treatment.3 
 
Preliminary Studies 
We conducted a pilot study of an adapted version of WHO BIC (called VA BIC) in psychiatrically 
hospitalized veterans at the White River Junction VA Medical Center.1 We found that rural veterans exposed to 
VA BIC experienced significant and clinically meaningful improvements in suicidal ideation at one and three 
months after discharge. We also observed significant improvements in related measures of suicide risk 
including hopelessness and connectedness. Patients had high continuity of care after discharge. To the best of 
our knowledge there have been no studies of targeted interventions for rural Veterans that address suicide risk 
during other high-risk care transition scenarios including discharge from an emergency room, inpatient medical 
stay or residential substance treatment facilities. The VA BIC has also not been pilot tested in these settings. 
Because of our promising pilot work, we believe it is appropriate to choose suicidal ideation as our primary 
outcome. In our pilot study, which included nine Veterans undergoing the VA BIC intervention, we found a 
greater than five-point improvement in the Beck Scale for Suicidal Ideation (BSS) over the three months 
following inpatient mental health discharge. Five points is a clinically meaningful improvement on the BSS as it 
represents the mean difference in suicidal ideation between ambulatory and hospitalized psychiatric patients.2 
Furthermore, with this sample size and level of improvement, we were able to demonstrate a significant 
difference in improvement in suicidal ideation compared to a matched group of historical controls participating 
in a post-mental health discharge qualitative study.1,3 Therefore, we believe that we will have sufficient power 
to show a clinically meaningful improvement in suicidal ideation overall and for each of the four high-risk care 
transition scenarios at one and three months after discharge if we enroll a total of 100 veterans (25 per 

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Protocol version date: 11/6/2019 
 
transition scenario) over 3 years. We will also assess other important measures of suicide risk including 
hopelessness, connectedness, fatal/non-fatal suicide attempts and treatment engagement. 4-7  Please see the 
Assessment Manual for all assessment templates (Appendix 2). We will assess post-discharge treatment 
engagement by evaluating continuity of care and disruptions of care (including missed appointments). We will 
abstract these data from the electronic medical record. In addition, we will ask veterans to report on any 
treatment they may have received outside of the VA healthcare system. We will use a standardized data 
collection form to collect information on non-VA treatment. We have already piloted this data collection form in 
our current pilot study. We will include three measures of continuity of care including intensity of treatment, 
regularity of care, and continuity of care across organizational boundaries). These measures of continuity of 
care have been shown to be associated with improved mental health outcomes.8 Because the focus of our 
project is on generating practical clinical results for rural VA facilities rapidly and cost-effectively, we will limit 
our longitudinal assessment to these outcomes. Finally, travel to appointments is a notable concern for 
veterans living in rural areas. We will give patients the choice to participate in VA BIC contact visits in-person, 
by telephone or via VA Video Connect. This approach aligns with the VA’s goal to expand the use of telehealth 
services. 
 
Our pilot work lends support that VA BIC holds great promise for preventing suicide in a high- 
resource, rural, VA setting. The VA BIC targets key factors that may contribute to suicide risk during high-risk 
care transition scenarios including problems with patient engagement in treatment and fragmented care in the 
post-discharge period.3,18,19,31 As a next step, it is important to confirm the effectiveness of VA BIC in 
addressing suicide risk in psychiatrically hospitalized veterans in rural settings and to determine whether VA 
BIC shows similar effectiveness during other high-risk care transition scenarios in rural veterans such as 
emergency room care, medical hospitalization, and residential substance treatment facilities. Results of our 
work will serve as an important resource for rural VA facilities to draw from in order to develop and implement 
effective programs to mitigate suicide risk in Veterans living in rural settings at their facilities. 
 
Research Design and Methods  
Study Protocol for Patients Recruited 
from Ground East  
As described in the Specific Aims section 
above, the proposed study will occur 
over the course of a total of four years 
with the funding of the study starting 
October 1, 2019. In year one of the 
study, we will first conduct a randomized 
trial of the intervention on Ground East. 
We made this decision because we have 
established experience conducting a 
small pilot of the intervention on the 
same unit. Therefore, it is it reasonable 
to first conduct a full clinical trial in a 
location where we the greatest 
experience and can gain important 
insights that will be helpful when we 
spread the study to other areas of the 
medical facility. Accordingly, we are 
requesting at this time from the IRB/R&D 
to open the study only on Ground East. 
Our plan is in then subsequently over the 
course of the years to submit 
amendments as appropriate to expand 
the study to additional locations with the 
WRJ VAMC as described in the protocol. 
For each additional site, we will modify the protocol and submit relevant consent forms because these will differ 
modestly across locations. The additional sites of interest includes the residential rehabilitation substance 
Figure 1. Flow chart of study procedures 
 
d=days; IC = inclusion criteria; m= months; MH = inpatient mental 
health; w = weeks 

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Protocol version date: 11/6/2019 
 
abuse program (RRC), the medical-surgical unit (specifically patients who were consulted by mental health and 
identified as being at risk for suicide), and the emergency room. 
 
This section outlines the study protocol for the clinical trial of VA BIC on Ground East. 
Overview of the VA BIC Intervention and RCT Design 
As shown in Figure 1 (see previous page), to test the aforementioned hypotheses, we propose to 
conduct a single-site, assessor-blinded RCT at the WRJ VAMC comparing the VA BIC plus standard 
psychiatric hospital discharge care to standard psychiatric hospital discharge care alone. The trial will 
enroll patients 18 years and older who are being discharged from the WRJ VAMC inpatient mental health 
unit.  The primary aim is to determine whether the VA BIC reduces suicidal ideation at one and three 
months after psychiatric hospitalization.  The secondary aim is to evaluate the impact of VA BIC on other 
important measures of suicide risk including hopelessness, connectedness, fatal/non-fatal suicide 
attempts and treatment engagement. 
Baseline Assessment and Randomization: Prior to the start of study enrollment, the statistician will 
independently prepare allocation cards using a permutated block schedule. The statistician will the put these 
cards into sealed, opaque, numbered envelopes. The box of envelopes will be stored in a locked cabinet in the 
study coordinator’s locked office.  
    The study coordinator will meet with each eligible patient in a private room on GE around the time of 
discharge.  The study coordinator will obtain informed consent from the patient and then administer the 
baseline assessments, which are described under the outcome measures (see below).  The baseline visit will 
take approximately 90 minutes to complete.  After obtaining consent and completing the baseline assessment, 
the study coordinator will take the next numbered envelope from the box (described above) and open the 
envelope to determine the patient’s assignment. In the event that the patient has been assigned to the 
intervention, the study coordinator will notify the VA BIC intervention staff in order that the intervention staff can 
initiate the intervention. Otherwise, the patient will be informed that they have been assigned to usual care.  
VA BIC Intervention Description: Patients assigned to the VA BIC intervention will receive the VA BIC plus 
the standard psychiatric hospital discharge care.  The VA BIC is an adaptation of the successful WHO BIC 
intervention and designed to meet the unique needs of Veterans receiving care in the VA medical system (see 
VA BIC Manual, Appendix 1).  VA BIC can be delivered by a trained mental health staff member, such as a 
mental health nurse, social worker, or psychiatrist.  The VA BIC targets the needs of patients who are being 
discharged from a VA inpatient mental health unit after having been admitted because of acute suicide risk.  
The VA BIC incorporates aspects of motivational interviewing (MI).  Since the VA BIC is designed to enhance 
the standard hospital discharge care that patients receive as part of psychiatric hospitalization, patients 
assigned to the VA BIC will continue to have access to standard discharge care (described below).  There are 
no restrictions on the types of treatments that patients may pursue after discharge.  
• 
 Brief Educational Intervention: Patients receive a one-hour, one-on-one, brief educational intervention 
on suicide prevention.  The session is performed by a VA BIC intervention staff member and takes 
place on the inpatient mental health unit around the time of discharge.  We anticipate that, in most 
cases, the patients will receive the intervention the day prior to discharge. The education is designed to 
meet the information needs of Veterans receiving mental health care in the VA and to address patient 
barriers to follow-up.  The education includes a discussion of the patient’s safety plan.  The sessions 
are highly interactive, allowing time for questions and providing patients with written materials that they 
can keep for future reference.  
• 
Regular Contact: The patients will maintain regular contact with the same VA BIC intervention staff 
member for a total of six contacts over the course of the three months after psychiatric hospitalization.  
At each of these contacts, the VA BIC intervention staff member will monitor the patient’s symptoms, 
assess treatment adherence, review the safety plan with the patient, and, if necessary, assist the 
patient with engaging in care.  The contact sessions will be systematic and structured.  The contacts 
are designed to be highly interactive, allowing times for questions and providing patients with written 
materials that they can keep for future reference.  Depending on the patient’s preference, the regular 
contacts will be delivered over the phone (or VA Video Connect) or in-person in a private office on the 
grounds of the WRJ VAMC. These visits last roughly 15-30 minutes. 

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Protocol version date: 11/6/2019 
 
 
Standard Psychiatric Hospital Discharge Care: Patients assigned to the VA BIC intervention as well as the 
control condition will receive the standard VA hospital discharge care that occurs as part of psychiatric 
hospitalization.  VA current standard psychiatric hospital 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 Suicide Prevention Coordinator (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. More recently, this enhanced care was renamed the Suicide Prevention 
Pathway.  The SPC oversees the following elements of the Suicide Prevention Pathway: 1) The SPC reminds 
the mental health provider that the patient should be scheduled to be seen four times within the first 30 days 
following hospitalization; 2) The primary care or mental health provider is expected to tailor the patient’s 
treatment to address his/her unique risk factors for suicide; 3) The SPC places a pop-up flag in the medical 
record to alert providers of the patient’s high-risk status; and 4) The continued need for the patient to remain on 
the High Risk for Suicide List is reassessed by the SPC every three months.  Of note, at the clinical discretion 
of the inpatient treatment team and the SPC, some patients may be assigned to the Suicide Prevention 
Pathway but may not meet criteria for the High Risk for Suicide List.  Per VA policy, SPCs are not required to 
provide clinical care. 
 
Outcome 
Measures: As 
outlined in Table 1, 
we will use several 
standardized 
instruments to 
collect information 
on primary and 
secondary 
outcomes 
throughout the 
study.  Copies of 
the assessment 
tools are available 
in the Assessment 
Manual (App 2).  
 
Baseline Characteristics:  We will collect socio-demographic data from the electronic medical record such 
as age, sex, marital status and service history (e.g., branch, era, combat exposure).  With regards to 
diagnostic information, we will administer the MINI International Neuropsychiatric Interview (MINI) at study 
entry.  The MINI is a short, structured diagnostic interview that takes about 15 minutes to administer.35 It 
has been validated against the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental 
Disorders (DSM).  We will inquire about any history of suicide attempts using the validated Columbia 
Suicide Severity Rating-Scale (C-SSRS).36  The C-SSRS includes a seven-item subscale that assesses for 
actual and interrupted suicide attempts.   
 
Primary Outcome (Suicidal Ideation): The primary outcome will be assessed using the Beck Scale for 
Suicidal Ideation (BSS) (Specific Aim 1).2,37  Patients will be asked about their current suicidal ideation (i.e., 
past week) at baseline and at follow-up assessments.  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. 38  The BSS is widely used in clinical trials, is 
Table 1: Overview of Standardized Assessment Measures and Timing of Assessment 
 
                  Measurement Methods 
Timing of 
Assessment 
Outcome 
Instrument 
Cronbach’s α 
Length 
Time* 
0M 1M 3M 
Suicidal Ideation 
BSS 
0.87 – 0.97 
21 items 
10 
X 
X 
X 
Patient Activation PIH 
0.82 – 0.88 
12 items 
5 
X 
X 
X 
Hopelessness 
BHS 
0.87 – 0.93 
20 Items 
10 
X 
X 
X 
Connectedness 
INQ-15 
0.89 – 0.91  
15 items 
5 
X 
X 
X 
Suicide Attempts 
CSSR-S 
N/A 
7 items 
5-10 
X 
X 
X 
Estimated time (in minutes) to complete assessments 
45 
45 
45 
BHS = Beck Hopelessness Scale; BSS = Beck Scale for Suicidal Ideation; CSSR-
S = Columbia Suicide Severity Rating Scale; INQ-15 = Interpersonal Needs 
Questionnaire-15; M = months; N/A = Not applicable; PIH = Partners in Health;  
*Time is described in minutes  

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Protocol version date: 11/6/2019 
 
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.2,39  There is evidence that an improvement of five points or more on the total BSS scores may be 
clinically relevant. 2   
 
Secondary Outcome (Patient Engagement): We will measure patient engagement in treatment at 
baseline and at follow-up assessments.  Patient engagement is a complex phenomenon to measure.40  The 
term ‘patient engagement’ encompasses various aspects of care related to a patient’s motivation and intent 
to be an active participant in addressing their healthcare needs.40  To date, there is no agreed-upon 
measure in the literature that incorporates all aspects of the experience of ‘patient engagement.40  In the 
field of mental health, there is some notion that ‘patient engagement’ should mean that a patient 
experiences collaborative care, feels supported during their treatment, and adopts ‘good practices’ or 
behaviors that support their overall well-being.40-41  Therefore, only assessing whether a patient attended a 
mental health appointment may not adequately reflect treatment engagement.  There is also evidence that 
symptom severity can preclude patients from engaging in care.42  Pfeiffer et al. found that, despite 
improvements in timely outpatient follow-up after VA psychiatric hospitalization, there were no significant 
changes in readmission or antidepressant treatment.43  In fact, Bernet et al. found that appointment 
intensity was higher in Veterans who reattempted suicide after discharge versus those who did not 
reattempt.44  Thus, we conceptualize that engagement includes continuity of care and activation.  
o Patient activation: Patient activation is defined as “an individual’s knowledge, skill and confidence for 
managing their health and health care.”45-46  Individuals who demonstrate higher degrees of patient 
activation have been found to be more likely to engage in health-promoting behaviors and to 
experience better outcomes.47  We will measure activation using the validated Partners in Health 
(PIH) scale.48  The PIH is a 12-item generic instrument that is used to measure patient self-
management of chronic conditions.48  It includes three domains of self-management including 
knowledge of condition, partnership in treatment, and coping with the condition.  It has good reliability 
and validity in patients with chronic conditions.49-50  The psychometric properties of the PIH in 
Veterans have not been studied. 
o Continuity of care: There is some evidence that improved continuity of care may lead to better 
mental health outcomes.51-52 However, a single, valid, standardized measure of continuity of care for 
mental health has not been described in the literature.  Work by Greenberg et al. in 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.8 We will use the three measures of continuity of care as validated by 
Greenberg et al.  This includes: 
a) Continuity of care: Measure of whether a patient discharged from the inpatient MH unit 
received any MH outpatient treatment in the first month and between 1 – 3 m after 
discharge. 
b) Regularity of care: The number of months in the 3 m after the initial assessment in which 
the patient attended at least 1 MH visit (Range 0 – 3 m), and  
c) Intensity of care: Measure of the total number of MH visits between initial entry into the 
study and the last study assessment).  
In addition, we will also evaluate evidence of disruptions of care including no-show and cancelled 
appointments. We will abstract these measures from the electronic medical record.  Since it is possible 
that some patients may receive portions of their care outside of the VA system, we will also ask patients 
to self-report on non-VA care.   
o Hopelessness: To gather clinical evidence of treatment engagement, we will assess hopelessness 
at baseline and at follow-up assessments using the Beck Hopelessness Scale (BHS).  The BHS is a 
20-item self-report scale that assesses hopelessness over the past seven days.53  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.39  The BHS has good reliability and validity and is sensitive to change.39  

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Protocol version date: 11/6/2019 
 
The psychometrics of the BHS in the Veteran population have not been studied, but the BHS has 
been used in other studies of the Veteran population.54 
o Secondary Outcome (Connectedness):  We will also include a measure of connectedness, the 
Interpersonal Needs Questionnaire-15 (INQ-15).  The INQ-15 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.5  The INQ-15 has 
good reliability and validity in the Veteran population.  Higher scores on the INQ-15 have been 
associated with suicide risk.5-6  
o Secondary Outcome (Suicide Attempts): We will assess for non-fatal and fatal suicide attempts at 
one and three months after discharge using the C-SSRS.36  The C-SSRS 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 scale asks the assessor to 
document the actual and potential lethality of these behaviors.  The C-SSRS is widely used in the 
VA.  The psychometrics of the C-SSRS in Veterans is unknown. 
o Study Design:  As shown in 
Figure 2, patients allocated 
to the VA BIC intervention will 
meet with the VA BIC 
intervention staff prior to 
hospital discharge.  During 
this visit, they will receive a 
brief educational intervention, 
which will be delivered in a 
private office on GE.  After 
hospital discharge, patients 
will participate in six regular 
contacts with the VA BIC 
intervention staff over a 
period of three months.  
Depending on patient 
preference, the regular 
contacts will occur in a 
private office on the WRJ 
VAMC campus or the contacts will occur over the phone (or VA Video Connect).  
o All patients (including patients randomized to VA BIC) will have access to standard psychiatric 
hospital discharge care.  Furthermore, regardless of study assignment, all patients will undergo 
outcome assessment at baseline (0M), one month (1M) and three months (3M). These assessments 
will be conducted by the independent outcome assessor.  The independent outcome assessor will 
conduct the baseline assessment in a private office on GE around the time of discharge.  We 
anticipate that, in most cases, the baseline assessment will occur on the day before discharge.  
Depending on patient preference, the independent outcome assessor will conduct the follow-up 
assessments in a private office on the WRJ VAMC campus or over the phone (or VA Video Connect). 
 The assessor will be blinded to study assignment and the patients will be instructed to not reveal 
their status to the assessor. 
o As the WRJ VAMC is a rural medical center that serves a large geographic area (New Hampshire 
and Vermont), we anticipate that several enrolled patients will prefer phone (or VA Video Connect) 
over in-person follow-up.  Fortunately, the assessment instruments that we selected for this study 
can be administered over the phone or in person.  Furthermore, our decision to allow patients to 
participate in study follow-up by phone (or VA Video Connect) or in person is consistent with the 
study methods of the original WHO BIC trials. 
Summary of Project Work/Deliverables over the 4 year study period 
1) Year 1: We will complete four deliverables during the first year: 
A) Enroll 25 veterans in a randomized trial of VA BIC for patients being 
discharged from an inpatient mental health unit. (As described in the study 
Figure 2. Schedule of Assessments and Interventions 
 
BIC = VA Brief Intervention and Contact Program; dy = days; m = month
MH = Mental health; SDP = Standard psychiatric discharge practices;    
   T0, T0, T1, T2 = assessment time points; wk = weeks 

9 
Protocol version date: 11/6/2019 
 
protocol above for patients recruited from Ground East) 
B) Develop an adapted version of the VA BIC for patients being discharged from 
an inpatient medical/surgical unit after receiving psychiatric consultation.  
C) Pilot an adapted version of VA BIC in 3 veterans being discharged from 
an inpatient Medical/surgical unit after receiving psychiatric consultation. 
(We will submit a study amendment prior to conducting this work) 
D) Develop an adapted version of VA BIC for patients being discharged from a 
residential substance treatment facility 
2) Year 2: We will complete six deliverables during the second year: (We will submit a study 
amendment prior to conducting the work described below) 
A) Clean and analyze data from trial of VA BIC for patients being discharged from 
an inpatient mental health unit. 
B) Finalize VA BIC manual for patients being discharged from an inpatient mental 
health unit based on results. 
C) Enroll 25 veterans in a randomized trial of VA BIC for patients being 
discharged from an inpatient medical/surgical unit after receiving psychiatric 
consultation. 
D) Pilot an adapted version of VA BIC in 3 veterans being discharged from a 
residential substance treatment facility. 
E) Enroll 13 veterans in a randomized trial of VA BIC for patients being 
discharged from a residential substance treatment facility. 
F) Develop an adapted version of VA BIC for patients being discharged from an 
emergency room after presenting with a mental health concern. 
3) Year 3: We will complete seven deliverables during the third year: (We will submit a study 
amendment prior to conducting the work described below) 
A) Clean and analyze data from trial of VA BIC for patients being discharged from 
an inpatient medical/surgical unit after receiving psychiatric consultation. 
B) Finalize VA BIC manual for patients being discharged from an inpatient 
medical/surgical unit after receiving psychiatric consultation based on results. 
C) Enroll 12 veterans in a randomized trial of VA BIC for patients being 
discharged from a residential substance treatment facility. 
D) Clean and analyze data from trial of VA BIC for patients being discharged from a 
residential substance treatment facility. 
E) Finalize VA BIC manual for patients being discharged from a residential 
substance treatment facility. 
F) Pilot an adapted version of VA BIC in 3 veterans following discharge from an 
emergency room after presenting with a mental health concern. 
G) Enroll 25 veterans in a randomized trial of VA BIC for patients being 
discharged from an emergency room after presenting with a mental health 
concern. 
4) Year 4: We will complete ten deliverables during the fourth year: (We will submit a study 
amendment prior to conducting the work described below) 
A) Clean and analyze data from trial of VA BIC for patients being discharged from an 
emergency room after presenting with a mental health concern. 
B) Finalize VA BIC manual for patients being discharged from an emergency 
room after presenting with a mental health concern. 
C) Integrate VA BIC trial data across high-risk care transition scenarios and analyze results. 
D) Develop integrated VA BIC manual including all four high-risk care transition scenarios. 
E) Identify three rural sites interested in implementing VA BIC. 
F) Disseminate VA BIC to 3 rural VA facilities 
G) Work with the three rural sites to adapt materials for their settings and assist 
facilities with implementation. 
H) Track use, success, and challenges of VA BIC implementation at the three rural sites. 

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Protocol version date: 11/6/2019 
 
I) Develop a generalizable VA BIC manual that is adaptable to any rural VA facility. 
J) Propose additional dissemination work to Rural Health Resource Center Eastern Region. 
 
Please see Table 2 below for a study timeline for the 4 year period. 
 
 
Table 2: Gantt Chart Representing Each of the Proposed Project Activities 
 
 
Calendar Year 
 
2019 
 
2020 
 
2021 
 
2022 
Quarter 
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 
Development and testing of VA BIC in 4 High-Risk Care Transition 
Scenarios Transition Scenario 1: Patients Being Discharged from an Inpatient Mental Health Unit 
    Enroll 25 veterans in a RCT of VA BIC 
Clean and analyze data 
Finalize VA BIC manual for mental health discharges 
Transition Scenario 2: Patients Being Discharged from an Inpatient Medical Unit after Receiving Psychiatric Consultation 
Develop adapted version of VA BIC for patients being discharged from an 
inpatient medical unit after receiving psychiatric consultation 
Pilot adapted version of VA BIC in 3 veterans being discharged from an 
inpatient medical unit after receiving psychiatric consultation 
Enroll 25 veterans in an RCT of VA BIC 
Clean and analyze data 
Finalize VA BIC manual for patients being discharged from an 
inpatient medical unit after receiving psychiatric consultation 
Transition Scenario 3: Patients Being Discharged from a Residential Substance Treatment Facility 
Develop adapted version of VA BIC for patients discharged from a RST 
Pilot adapted version of VA BIC in 3 veterans discharged from a RST 
Enroll 25 veterans in an RCT of VA BIC 
Clean and analyze data 
Finalize VA BIC manual for patients discharged from a RST 
Transition Scenario 4: Patients Being from an Emergency Room after Presenting with a Mental Health Concern 
Develop adapted version of VA BIC for patients discharged from an ER 
after presenting with a mental health concern 
Pilot adapted version of VA BIC in 3 veterans discharged from an ER 
after presenting with a mental health concern 
Enroll 25 veterans in an RCT of VA BIC 
Clean and analyze data 
Finalize VA BIC manual for patients discharged from an ER 
after presenting with a mental health concern 
                                   Integration of Findings from VA BIC Use in 4 High-Risk Care Transition Scenarios 
Integrate VA BIC trial data 
Analyze results 
Develop integrated VA BIC manual 
Write up Manuscript of Work 
Dissemination of VA BIC Findings to Rural VA Facilities 
Identify 3 rural VA facilities interested in implementing VA BIC 
Work with 3 rural VA facilities to adapt VA BIC material locally 
Assist 3 rural VA facilities with implementation of VA BIC 
Track use, success, and challenges of VA BIC implementation by facilities 
Develop a generalizable manual that is adaptable to any rural VA facility 
Propose additional dissemination work to RHRCER 
Manual Development and Testing Work 
Integration Work 
Dissemination Work 
Note. ER = Emergency Room; RCT = Randomized controlled trial; RHRCER= Rural Health Resource Center Eastern Region; RST = Residential 
Substance Treatment Facility; VA = Veterans Affairs; VA BIC = VA Brief Intervention and Contact Program 
 
 

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Protocol version date: 11/6/2019 
 
Statistical Considerations 
 
Statistical Analyses: To maintain blinding, the statistician who is otherwise not directly involved in the study 
will conduct the analysis based on the intention-to-treat principle.  Below, we have outlined the specific 
analysis plan for assessing each of the primary and secondary aims of interest of this study.  We will assess 
for statistically significant differences in baseline study characteristics such as age, sex, race, and mental 
health diagnosis, between study arms using t-tests for continuous measures and chi-squared tests for 
dichotomous variables.  We will report these results using 95% confidence intervals (CI) and P-values.  We will 
define statistical significance as a P-value < 0.05.  If we identify any variables for which there are significant 
differences across study arms, we will control for these confounders in the analysis of the aims.  
 
Specific Aim 1:  We will generate descriptive summary statistics (e.g., means and standard errors, 
medians) and graphical displays for the BSS total scores at baseline and at each of the follow-up 
assessments. For each of the four acute care settings included in our study, we will perform simple 
statistical tests. First, we will use a repeated measures analysis of variance (ANOVA) test to assess for 
changes in continuous variables in the first three months after discharge. Second, if the repeated 
measures ANOVA suggested a significant difference in means across time, we will perform a post-hoc, 
pair-wise comparison of means at baseline and one- and three-month follow-up using a two-sample t-test.  
    We will perform a more complex analysis for the entire study sample at the end of the four years 
because we will have adequate power to do so. The following outlines are specific approach: Based on 
available evidence, we hypothesize that the VA BIC program plus standard hospital discharge care will 
lead to a significant reduction in suicidal ideation after discharge from an acute care setting.  We believe 
that the effect of VA BIC on suicidal ideation will be the greatest at the three-month follow-up because the 
greatest intensity of follow-up care provided through VA BIC occurs within the first three months after 
discharge. We will generate descriptive summary statistics (e.g., means and standard errors, medians) 
and graphical displays for the BSS total scores at baseline and at each of the follow-up assessments.  
Because BSS scores are typically over dispersed, it is not appropriate to use standard parametric 
statistics.  Therefore, we will treat the BSS scores as count data and use negative binomial regression.  
Specifically, we will use a generalized linear mixed model.  We will consider allocation of study arm 
(categorical measure) and time (continuous measure) as fixed effects.  Random effect will be used to 
account for correlation that arises from repeated measures of the same individual.  We will assume a linear 
effect and model changes in suicidal ideation over time.  We will calculate 95% CI and P-values and will 
define a P-value of < 0.05 to be statistically significant.  We will use the maximum likelihood ratio to 
account for any missing data. 
 
Specific Aim 2: First, we will perform an analysis to demonstrate whether there are greater improvements in 
patient engagement, hopelessness, and perceived connectedness over time in patients assigned to the VA 
BIC intervention versus control condition at one, three months after discharge.  For continuous variables 
measuring patient engagement (PIH, Hopelessness, Regularity of Care, Continuity of Care across 
Organizational Boundaries, and Intensity of Care) and perceived connectedness (INQ-15), we will generate 
descriptive summary statistics (e.g., means and standard errors, medians) and graphical displays for each 
measure at baseline and at each of the follow-up assessments.  Second, using analysis of covariance 
(ANCOVA), we will calculate mean differences in scores for each of our continuous measures at the one-and 
three-month follow-up, as well as the associated 95% confidence intervals and P-values.  For the categorical 
measure of disruptions in care, we will use chi-squared tests to compare the proportion of patients 
experiencing disruptions in care between the two study arms at one- month and three-months after discharge. 
 
Specific Aim 3: While suicide deaths and suicide attempts are important clinical endpoints, this single-site trial 
will not be powered to detect a statistically significant effect between study arms.  Furthermore, because we 
assume that few events will be observed in either arm, we plan to summarize our findings by providing basic 
descriptive statistics regarding the number of events in each arm at one-and three-month follow-ups.   
 
 
 

12 
Protocol version date: 11/6/2019 
 
Randomization: Prior to the start of study enrollment, the statistician will independently prepare allocation 
cards using a permutated block schedule. The advantage of this approach is that it ensures that an equal 
number of participants are assigned to each arm.56  The statistician will the put these cards into sealed, 
opaque, numbered envelopes. The box of envelopes will be stored in a locked cabinet in the study 
coordinator’s locked office. 
 
Sample Size: Because of our promising pilot work,1 we believe it is appropriate to choose suicidal ideation as 
our primary outcome. In our pilot study, which included nine Veterans undergoing the VA BIC intervention, we 
found a greater than five-point improvement in the Beck Scale for Suicidal Ideation (BSS) over the three 
months following inpatient mental health discharge. Five points is a clinically meaningful improvement on the 
BSS as it represents the mean difference in suicidal ideation between ambulatory and hospitalized psychiatric 
patients.2 Furthermore, with this sample size and level of improvement, we were able to demonstrate a 
significant difference in improvement in suicidal ideation compared to a matched group of historical controls 
participating in a post-mental health discharge qualitative study.1,3 Therefore, we will have sufficient power to 
show a clinically meaningful improvement in suicidal ideation overall and for each of the four high-risk care 
transition scenarios at one and three months after discharge if we enroll a total of 100 veterans (25 per 
transition scenario) over 3 years. 
 
Study Population and Recruitment 
As described in the Specific Aims section, the proposed study will occur over the course of a total of four years 
with the funding of the study starting October 1, 2019. In year one of the study, we will first conduct a 
randomized trial of the intervention on Ground East. We made this decision because we have established 
experience conducting a small pilot of the intervention on the same unit. The first stage of the study will be 
conducted at the WRJ VAMC and will recruit patients hospitalized on Ground East (GE), the facility’s 10-bed 
inpatient mental health unit.  GE staff includes an inpatient psychiatrist and psychologist, nursing staff, a social 
worker, and trainees from these disciplines.  We aim to recruit a total of 25 patients from Ground East. Study 
staff will communicate on a daily basis (Monday-Friday) with the inpatient treatment team in order to identify 
potentially eligible patients who can be approached about study participation. The inpatient team and attending 
psychiatrist will make the determination as to when and whether it is clinically appropriate for study staff to 
approach potentially eligible patients.  After approaching eligible patients, study staff will make them aware of 
the study and determine if they are interested in participating in the study.  If patients are interested in the 
study, study staff will obtain informed consent using a written informed consent document prior to enrolling the 
patient into the study.  Study staff involved in the recruitment and consent process will be blinded at the time of 
study allocation.  During the course of the study, it will be impossible to blind the VA BIC intervention staff or 
patients to treatment allocation; however, the outcome assessor will remain blind to study assignment 
throughout the trial.  Patients will be instructed not to reveal their study assignment to the outcome assessor.  
 
Inclusion Criteria: 
o 
Per the unit psychiatrist, hospitalization was due to concerns about acute risk for self-harm 
including suicidal ideation, suicide attempt, and/or admitting provider deemed the patient was at 
imminent risk for self-harm;  
o 
Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English;  
 
Exclusion Criteria: 
o 
Unable to provide informed consent;  
o 
We do not plan to enroll any potentially vulnerable populations including prisoners, institutionalized 
patients, or involuntarily committed patients.  
 
Informed Consent 
Eligible participants who are interested in participating in this study will complete the informed consent process. 
Study staff will inform the patient about the study and provide them with the informed consent document. 
Patients will have the option to review the document with their doctor, family, and/or friends prior to signing if 
they choose. Upon signing, they will be provided with a photocopy of the document. We do not anticipate a 
waiting period between informing the patient of the study and obtaining informed consent, but participants may 

13 
Protocol version date: 11/6/2019 
 
choose to wait. To ensure understanding of the study purpose and procedures, the patient will be encouraged 
to ask questions if there is anything they do not understand. Additionally, the informed consent document is 
written in easy-to-understand language to facilitate comprehension. 
 
Risks and Side Effects: 
 
Potential Risks  
Since the study population is known to be at high risk for suicide and study endpoints include suicidal ideation, 
suicide attempts, and suicide, these events would be considered anticipated adverse events during the course 
of this study. Similarly, we also consider that psychiatric hospitalizations or emergency room for worsening 
psychiatric symptoms or suicidal behavior are anticipated adverse events.   
 
As described above, it is expected that patients may report worsening suicidal ideation or suicidal behaviors at 
the study assessments (i.e., baseline, one-month, or three-month follow-up) regardless of whether they are 
assigned to the intervention or control condition. It is also possible that patients assigned to the intervention 
arm may report worsening suicidal ideation or suicidal behavior during an intervention visit. It is also possible 
that patients could be seen in the emergency room or be hospitalized because of any of these events. Thus, it 
is expected for the patients to continue with the study unless the patient requests to be removed from the 
study.  Furthermore, as outlined in our safety alert protocol (Appendix 3), study personnel will immediately 
follow the safety alert protocol in response to any reports of worsening suicidal ideation or behaviors. If 
necessary, patients will be connected immediately with required clinical treatment.  All patients will continue to 
have access to standard-of-care treatment during the course of the trial regardless of study assignment.  
Furthermore, all patients may continue any treatments that they were receiving as part of their routine care 
prior to enrolling in the study.   
 
Therapeutic Risks  
During the trial, the research staff will ask patients questions about how they are feeling and their interactions 
with other people.  Patients will be exposed to these therapeutic risks during the baseline and follow-up 
assessments at one- and three-month follow-ups.  In addition, patients assigned to the intervention condition 
will also be exposed to these therapeutic risks at the intervention visits (brief education visit plus six contact 
visits after discharge).  Sometimes, patients can feel embarrassed, nervous, bored, or generally uncomfortable 
when they are asked to answer these types of questions.  However, because there are sufficient safeguards in 
place to mitigate these potential risks, the overall therapeutic risk from this study to enrolled patients is very 
low.   
 
Research Risk  
During the course of the trial, protected health information including name, social security numbers (in order to 
process participant payments), phone numbers (for contact purposes), sociodemographic information (e.g. 
age, race), psychiatric diagnoses (e.g. Alcohol Use Disorder, Substance Use Disorder, Depression), mental 
health treatments received, and psychiatric symptoms (e.g. responses to standardized questionnaires) will be 
collected from all enrolled patients.  Thus, there is some risk that a patient’s confidentiality or protected health 
information could be compromised due to study participation.  As there are sufficient safeguards in place to 
mitigate this risk (see Protection Against Risk below), the overall research risk in this study is very low. 
 
Protection Against Risk  
Study Population Safety Risk  
At each study assessment time point (i.e., baseline, one-month, and three-month follow-up), patients will be 
assessed for symptoms of suicidal ideation and suicidal behavior because these are a priori study endpoints. 
In addition, for patients assigned to the intervention, patients may report worsening suicidal ideation or suicidal 
behavior in the context of the intervention visits.  Regardless of whether the patient is assigned to the 
intervention or control condition, the study staff will be ethically bound to take appropriate action if the patient is 
at imminent risk for self-harm.  The safety alert protocol (Appendix 3) outlines the process that study staff 
members will follow in order to ensure the safety and well-being of all enrolled patients regardless of whether 
they are assigned to the intervention or control condition. In the event that a safety alert is met, the research 

14 
Protocol version date: 11/6/2019 
 
staff member will contact Dr. Natalie Riblet (or the mental health physician covering for her) or, if necessary, 
the patient’s mental health provider.  As part of this risk assessment, the assessing clinician will immediately 
complete a comprehensive risk evaluation and determine the most appropriate next level of care for the 
patient.  The next level of care may include psychiatric admission, emergency room referral, or an urgent 
outpatient appointment with the patient’s healthcare provider.  Please see the safety alert protocol (See 
Appendix 3) for a full description of all safety alerts and required actions by study staff members.   
 
Therapeutic Risk  
Patients will be given ample time to answer questions and complete visits in order to reduce any discomfort 
they may experience.  Patients will also be made aware that if any of the questions make them feel 
uncomfortable, they should feel free to mention this to the study staff member and have this concern 
addressed immediately.  At any point during a visit, a patient can take a break or refuse to answer a question.  
 
Research Risk  
Every effort will be made to ensure that the privacy and confidentiality of the patient is maintained.  All study 
visits will occur in a private office on the WRJ VAMC campus to ensure privacy.  If a visit or assessment is 
done via a phone call, the research staff will conduct the phone call in a private office.  All assessments that 
can be collected electronically will be stored on a secure, password-protected file on a secure, local researcher 
server.  All staff associated with the study will complete required security training prior to the start of the study 
in order to be permitted access to this server.  Furthermore, all study staff will adhere to the required annual 
training (by the WRJ VAMC) necessary to maintain their access to the server.   All paper copies of study-
related data, including consent and HIPAA forms, will be kept in a locked file cabinet, in a locked office, 
dedicated to this study.  Only research staff will have access to this locked cabinet. 
 
Benefits:   
All patients participating in this trial will receive standard of care and will be able to continue all treatments 
and mental health care that they would otherwise have access to outside of the study.  In addition, 
depending on study assignment, some patients may receive the VA BIC intervention.  The VA BIC is 
designed to enhance care that patients receive by helping to connect them with available mental health 
resources and educating them about suicide prevention after psychiatric hospitalization.  Although the VA 
BIC is adapted from a successful suicide prevention strategy (WHO BIC),32,34 it is unknown whether the VA 
BIC significantly reduces suicide risk after psychiatric hospitalization relative to standard discharge 
practices.  The work from this proposed study will be able to more definitively address whether the VA BIC 
intervention is an effective suicide-prevention strategy in patients following a psychiatric hospitalization.  
This is important, given that death by suicide after psychiatric hospitalization remains an important problem 
in the Veteran population despite the VA’s multiple suicide-prevention strategies.  Since the overall risks 
associated with this trial are minimal and the anticipated benefits and knowledge to be gained are clinically 
important, there is sufficient reason to conduct this study. 
 
Protected Health Information: 
We will administer several validated instruments to all enrolled patients at baseline and follow-up (one-and 
three-month follow-ups).  These instruments ask various questions related to self-harming thoughts or 
behavior and social connectedness.  We will also ask patients to report on any non-VA healthcare 
utilization at one- and three-month follow-ups.  Demographic data and other baseline characteristics will be 
collected from the patient’s electronic medical record at baseline.  Information on VA healthcare utilization 
will be collected from the patient’s electronic medical record at one- and three-month follow-ups.  All data 
will be collected solely for the purposes of this study.  All study data will be collected using an electronic 
data-capture system.  These data are stored on a local, secure research server that only study staff will 
have access to. All paper copies of study-related data, including consent and HIPAA forms, will be kept in a 
locked file cabinet, in a locked office, dedicated to this study.  Only research staff will have access to this 
locked cabinet. 
 
Multi-Site Study Concerns   
In Year 4 of the study, we will identify three rural sites interested in implementing VA BIC and work with these 

15 
Protocol version date: 11/6/2019 
 
sites to implement VA BIC locally. Prior to conducting this work, we will submit a study amendment to VINNE. 
 
 
 
Resources Available    
This project will be conducted at WRJ VAMC. For the first phase of the study, recruitment of 25 participants will 
take place on Ground East. Over the next phases of the study, we will be recruiting 25 participants from each of 
the following locations including inpatient medical/surgical services, residential drug treatment program (RRC) and 
the emergency room. Drs. Shiner and Riblet will oversee and lead this project with the help of research staff, 
which includes: 
• 
A VA BIC interventionist (100% Year 1, 2, 3; 50% Year 4) 
• 
A study coordinator (100% all 4 Years) 
• 
A statistician (10%, Year 1, 2, 3; 20% Year 4) 
• 
An independent assessor blinded to study arm (50% in Years 1-3) 
• 
An implementation scientist to aid Drs. Shiner and Riblet to work with 3 rural VA facilities and develop 
generalizable materials to disseminate VA BIC broadly in rural VA facilities through future work. 
 
Subject Compensation:  
We will compensate enrolled patients as follows: baseline: $50; one-month follow-up: $100; three-month 
follow-up: $150.  This schedule ensures that patients are sufficiently reimbursed for their time and effort in the 
study.  Furthermore, the staggered schedule of higher payments over time accounts for the additional burden 
of committing to the study for three months.  Finally, higher payments have been shown improve study 
retention, while not being unreasonably coercive.57-58 
 
Privacy and Confidentiality: 
Please see Protection Against Risk above. 
 
Data and Safety Monitoring Plan 
Monitoring and Interim Analysis Plan: We have formed an independent Data Safety Monitoring Board 
(DSMB) comprised of Peter Mills, PhD (has expertise in ethics and has previously served on a DSMB), Yinong 
Young-Xu, ScD (statistician who has experience serving on the Dartmouth-Hitchcock DSMB), and Bradley V. 
Watts, MD MPH (who has experience in mental health and suicide prevention). The independent DSMB will 
provide independent data and safety monitoring for this study. The DSMB will meets annually. The DSMB will 
focus on ensuring safety and feasibility, including participant accrual and retention, adverse events monitoring, 
and data analyses. Based on these findings, the DSMB may recommend: (1) continued approval 
(unconditionally or with conditions to be addressed); (2) probation; or (3) possibly termination, if there are 
problems with enrollment or safety concerns. We will also ask that the DSMB perform an independent, interim 
statistical analysis on our data on an annual basis. Dr. Young-Xu has experience performing these types of 
analyses. This will allow us to identify whether the treatment has greater benefits or risks than anticipated and 
make necessary changes to the trial including changing the trial or terminating the trial. 
 
Study Safety & Monitoring:  
Enrolled patients will be monitored for any unanticipated problems or adverse events during the course of the 
study. Unanticipated death possibly related to research will be orally reported to VINNE immediately with a 
written report submitted via IRBNet within 5 business days. Possibly study-related unanticipated problems 
involving risk to subjects or others; serious adverse events; and deviations/non-compliance will be reported 
within 5 business days to VINNE. Adverse events will be reported with continuing review. Information security 
or privacy incidents will be reported to the ISO or PO within one hour of discovery. As described above, we 
consider that the following events are anticipated adverse events: suicidal ideation, suicide attempts, suicide, 
and psychiatric hospitalizations or emergency room for worsening psychiatric symptoms or suicidal behavior.   
 
Reasons for stopping assigned treatment and follow-up:  
The following events will be considered reasons to stop assigned treatment and or follow-up of an enrolled 
patient:  (1) death because the patient would no longer be accessible to study staff; or (2) patient requests 
to withdraw from the study.  In the event that the patient is assigned to the intervention, we will ask the 

16 
Protocol version date: 11/6/2019 
 
patient if they are willing to continue with the outcome assessments but respect his/her wishes if he/she 
chooses to withdraw from the study.  
   
Step-by-Step Guidance on Conducting 
the Study 
 
 
 
 
Figure 1. Flow chart of study procedures 
d=days; IC = inclusion criteria; m= months; MH = inpatient mental 
health; w = weeks 
Figure 2. Schedule of Assessments and Interventions 
 
BIC = VA Brief Intervention and Contact Program; dy = days; m = month
MH = Mental health; SDP = Standard psychiatric discharge practices;    
   T0, T0, T1, T2 = assessment time points; wk = weeks 

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Protocol version date: 11/6/2019 
 
References & Literature Cited  
 
 
1. 
Riblet N, Shiner B, Schnurr P, Bruce ML, Wasserman D, Cornelius S, Scott R, Watts BV. A 
Pilot Study of an Intervention to Prevent Suicide following Psychiatric Hospitalization. 
Journal of Nervous and Mental Disease 2019 (in press). 
2. 
Beck AT, Kovacs M, Weissman A. Assessment of suicidal intention: the Scale for Suicide 
Ideation. J Consult Clin Psychol. 1979;47:343 – 52. 
3. 
Riblet N, Shiner B, Scott R, Bruce ML, Wasserman D, Watts BV. Exploring Psychiatric 
Inpatients' Beliefs About the Role of Post-discharge Follow-up Care in Suicide Prevention. 
Military medicine. 2018. 
4. 
Ribeiro, J. D., Huang, X., Fox, K. R., & Franklin, J. C. (2018). Depression and hopelessness 
as risk for suicide ideation, attempts, and death: a meta-analysis of longitudinal studies. Br J 
Psychiatry, 212, 279-286. doi: 10.1192/bjp.2018.27. 
5. 
Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and 
perceived burdensomeness: construct validity and psychometric properties of the 
Interpersonal Needs Questionnaire. Psychol assessment 2012;24(1):197-215. 
6. 
Gutierrez PM, Pease J, Matarazzo BB, et al. Evaluating the psychometric properties of 
the Interpersonal Needs Questionnaire and the Acquired Capability for Suicide Scale in 
military veterans. Psychol assessment 2016;28(12):1684-1694. 
7. 
Magnezi R, Glasser S, Shalev H, Sheiber A, Reuveni H. Patient activation, depression 
and quality of life. Patient Educ Couns. 2014;94(3):432 – 7. 
8. 
Greenberg GA, Rosenheck RA. Continuity of care and clinical outcomes in a national 
health system. Psychiatr Serv. 2005;56:427 – 33. 
9. 
National Institute of Mental Health. Suicide May 2018. 
https://www.nimh.nih.gov/health/statistics/suicide.shtml 
10. 
VHA. VA National Suicide Data Report, 2005 – 2015. Office of Mental Health and Suicide 
Prevention. https://www.mentalhealth.va.gov/docs/data- 
sheets/OMHSP_National_Suicide_Data_Report_2005-2015_06-14-18_508-compliant.pdf. 
11. 
VHA. Suicide among Veterans and Other Americans, 2001 – 2014. Office of Suicide 
Prevention. https://www.mentalhealth.va.gov/docs/2016suicidedatareport.pdf. 
12. 
Rossen LM, Hedegaard H, Khan D, Warner M. County-Level Trends in Suicide Rates in 
the U.S., 2005-2015. American journal of preventive medicine. 2018;55(1):72-79. 
13. 
McCarthy JF, Blow FC, Ignacio RV, Ilgen MA, Austin KL, Valenstein M. Suicide Among 
Patients in the Veterans Affairs Health System: Rural–Urban Differences in Rates, Risks, 
and Methods. American Journal of Public Health. 2012;102(S1):S111-S117. 
14. 
Brenner LA, Barnes SM. Facilitating treatment engagement during high-risk transition 
periods: a potential suicide prevention strategy. Am J Public Health. 2012;102 Suppl 
1:S12-14. 
15. 
Chung DT, Ryan CJ, Hadzi-Pavlovic D, Singh SP, Stanton C, Large MM. Suicide Rates 
After Discharge From Psychiatric Facilities: A Systematic Review and Meta-analysis. 
JAMA psychiatry. 2017;74(7):694-702. 
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