Examining a Strategy to Engage Rural Veteran Patients After Community Care Treatment
Phase: NA
Conditions: Suicide Prevention
Sponsor: White River Junction Veterans Affairs Medical Center

Official Title: Reengaging rural patients in VA mental health care after VA-community care 
network referral 
NCT Number: NCT06139887 
Document Date: 11/27/2023 

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Title 
Reengaging rural patients in VA mental health care after VA-community care network 
referral.  
Investigators  
Natalie Riblet, MD, MPH is the Principal Investigator of this study. 
Specific Aims/Purpose 
Rural patients who receive mental health treatment through VA-Community Care 
Networks (VA-CCN) represent a special population of high-risk patients because they 
have demonstrated an acute mental health need yet are not routinely included in VA 
suicide prevention programming. This is a critical gap in care. We have previously 
developed a suicide prevention intervention to decrease suicide risk in patients during 
high-risk transition scenarios. The intervention is called the VA Brief Intervention and 
Contact Program (VA BIC) and is an adaptation of the successful World Health 
Organization Brief Intervention and Contact Program (WHO BIC). VA BIC aims to prevent 
suicide by educating VA patients around suicide risk, promoting treatment engagement, 
and increasing social connectedness. Our pilot work with VA BIC in VA inpatient and 
outpatient settings suggests that VA BIC may decrease suicidal ideation, reduce 
hopelessness, increase social connectedness, and improve treatment engagement. A 
quality improvement project of BIC at six rural VA facilities also found that on average, 
patients rate BIC as excellent and site staff perceive that BIC is implementable.  
Building off our pilot work with VA BIC, we propose a two-year project arc to address 
current gaps in care by adapting the VA BIC intervention to promote re-engagement in 
VA care for VA-CCN patients and prevent suicide. Our project will consist of three 
phases. In Phase 1, we will develop a reliable method to incorporate our VA BIC 
intervention into care processes for rural patients who are discharged from VA-CCN 
mental health treatment settings. This adaptation will extend VA BIC to the VA-CCN. 
Our adaptation will be called the Building VA Engagement, Self-efficacy, and Social 
Support To Prevent Suicide (BESST) intervention. During Phase 2, we will pilot test the 
BESST intervention in a cohort of patients. Finally, during Phase 3, we will conduct a 
randomized trial of BESST versus usual care to determine whether BESST improves re-
engagement in VA-provided mental health services and suicide-related outcomes in the 
VA-CCN population 
Study Objectives and Specific Aims 
The overall goal of our proposed work is to develop a key resource for rural VA 
facilities to use to keep patients who are referred to (and discharged from) VA-CCN 
mental health treatment settings involved in VA care and to prevent suicide. To achieve 
our overall goal, we intend to pursue the following aims: 
Aim 1: During phase 1, we will determine a reliable method to incorporate our VA BIC 
suicide prevention intervention into care processes for rural patients discharged from 
VA-CCN mental health treatment settings. 
 

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Hypothesis: We will develop a reliable method to incorporate VA BIC into care 
processes for rural patients discharged from VA- CCN mental health treatment 
settings. The adaptation will be called the Building VA Engagement, Self-
efficacy, and Social Support To Prevent Suicide (BESST) intervention. 
Aim 2: During phase 2, we will pilot test the BESST intervention in four to six rural 
patients who are referred to (and discharged from) a VA-CCN mental health treatment 
setting. 
 
Hypothesis: We will obtain data on the feasibility of studying the BESST 
intervention in rural patients who are referred to (and discharged from) a VA-
CCN mental health treatment setting. We will identify any further modifications 
that may be required prior to studying BESST in this population.  
Aim 3: During phase 3, we will conduct a randomized trial of the BESST intervention 
versus usual care in rural patients who are referred to (and discharged from) VA-CCN 
mental health treatment settings. We aim to determine whether the BESST 
intervention can improve suicide-related outcomes in this population.  
Hypothesis: We will determine whether the BESST intervention reduces suicidal 
ideation and hopelessness and improves social connectedness and treatment 
engagement in rural patients who are referred to (and discharged from) VA-CCN 
mental health treatment settings. 
Note:  As show in Table 1, we will develop a reliable method to incorporate our VA BIC 
intervention into care processes for rural patients who are discharged from VA-CCN 
mental health treatment settings.  
Table 1: Proposed phases of study of the BESST intervention in rural patients. 
Phase 
Aim 
Proposed study activities during phase of work 
Phase 
One 
Aim 1 
•
Recruit three rural VA facilities and their affiliated VA-CCN sites.
• Use an interview guide to interview site staff about current VA-CCN
processes of care and to determine a reliable method to incorporate VA
BIC into these processes. The adaptation will be called BESST.
Phase 
Two 
Aim 2 
• Pilot study of BESST in 4 – 6 patients who access VA-CCN care.
• Finalize the BESST manual.
Phase 
Three 
Aim 3 
• Use results of Phase 1 and 2 to inform the design of a pilot, randomized
trial of the BESST intervention for VA-CCN mental health settings. 
BESST = Building VA Engagement, Self-efficacy, and Social Support To Prevent Suicide; VA BIC = 
VA Brief Intervention and Contact Program; VA-CCN = VA Community Care Networks;  
Scientific Rationale and Significance 
     A growing number of rural patients receive portions of their care in VA Community 
Care Network (VA-CCN) settings. In fact, VA researchers have observed that nearly 
40% of recipients of VA-CCN services live in rural areas.1 In Fiscal Year (FY) 2021, the 

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White River Junction VA Medical Center (WRJ VAMC) reported over 300 VA-CCN 
inpatient and residential mental health stays among its patient panel. Growth in VA-
CCN use is concerning because rural patients may experience worse outcomes in 
VA-CCN settings due to problems such as breakdowns in communication.2 
Importantly, this may prompt patients to disengage from VA-delivered care following a 
VA-CCN stay. 
    Rural patients are at the highest risk for suicide following an inpatient or residential 
mental health stay for the treatment of mental health conditions or substance use 
disorders (SUD).3, 4 Several factors may contribute to this finding such as poor social 
support,5 limited engagement in care5 and poor access to care.5, 6 The VA has 
developed a suite of strategies to address suicide risk in patients following a mental 
health discharge.7, 8 The VA suicide prevention program, however, does not extend 
to patients who are treated in VA-CCN mental health treatment settings. In fact, 
there is no evidence-based approach to assist rural patients with re-engaging with VA 
care after a VA-CCN discharge and to mitigate their suicide risk. These findings 
highlight a crucial gap in the VA’s efforts to keep rural patients engaged in VA care and 
to prevent suicide. 
    We developed a suicide prevention strategy called the VA Brief Intervention and 
Contact Program (VA BIC).9-11 A key goal of VA BIC is to mitigate suicide risk by helping 
rural patients to stay engaged in VA care after mental health discharge from a VA 
treatment program.9-11 Our pilot work and testing of VA BIC at the White River Junction 
VA Medical Center suggests that VA BIC may reduce suicidal ideation and 
hopelessness and improve social connectedness and treatment engagement.9-11 Based 
on our positive results, we believe that VA BIC can be adapted to meet the needs of 
rural patients who are referred to (and discharged from) VA-CCN mental health 
settings. Our VA BIC adaptation will be called the Building VA Engagement, Self-
efficacy, and Social Support To Prevent Suicide (BESST) intervention. The BESST 
intervention will aim to increase engagement in VA care among rural patients and to 
decrease their suicide risk. Ultimately, our work will lead to the development of a key 
resource for rural VA facilities to use to keep patients who are referred to (and 
discharged from) VA-CCN mental health settings involved in VA care and to prevent 
death by suicide.  
Preliminary Studies 
      Several brief interventions have been developed to address the risk for suicide 
following psychiatric and emergency room discharge.12 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.12 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.13 The WHO BIC also aims to ensure 
continuity of care after discharge by facilitating the communication of emergent patient 

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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.9-11 
We conducted a pre-post study of an adapted version of WHO BIC (called VA 
BIC) in nine psychiatrically hospitalized Veterans at the White River Junction VA 
Medical Center (WRJ VAMC).10 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 treatment engagement after discharge. Subsequently, we performed a pilot 
RCT of VA BIC in 19 psychiatrically hospitalized Veterans.9 Aligned with the results of 
our pre-post study, we found that VA BIC had a medium or large effect on suicidal 
ideation, hopelessness, social connectedness at one month after discharge. 
Furthermore, the effect on social connectedness remained large at three months. VA 
BIC also had a medium effect on treatment engagement. 
         The study of VA BIC during other high-risk transition scenario settings has also 
yielded promising results. We performed a pilot RCT of VA BIC in 19 Veterans who 
presented to a primary care mental health walk-in clinic for a new mental health intake 
appointment and were at risk for suicide.11 We identified that it was feasible to conduct a 
virtual trial of the intervention in this population. Moreover, the results suggested that 
Veterans assigned to the intervention may experience improvements in suicidal ideation 
as well as higher treatment engagement. We are also currently completing a study of 
the VA BIC in Veterans who are admitted to a VA residential treatment program for the 
management of substance use disorder. We were able to meet our recruitment goal of 
20 Veterans. The results of this study are not yet available. Finally, we collaborated with 
the VA Office of Rural Health, the VA National Center for Patient Safety, and the VA 
Office of Systems Redesign in a quality improvement (QI) project that examined the BIC 
program in six, rural VA facilities.14 The results of the QI work suggested that Veterans 
on average rate the BIC program as excellent and VA providers perceive that BIC is 
implementable. 
      To the best of our knowledge there have been no studies of targeted interventions 
for rural patients that address suicide risk and treatment engagement after discharge 
from VA-CCN mental health treatment settings. The VA BIC (or any related adaptations) 
have also not been tested in these settings. Therefore, as a next step, we propose to 
determine current processes of care for rural patients who are referred to (and 
discharged from) VA-CCN mental health treatment settings. We will then develop, and 
pilot test a VA BIC adaptation (called the BESST intervention) that is optimized to meet 
the needs of rural patients who are referred to (and discharged from) VA-CCN mental 
health treatment settings. 

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Finally, we will conduct a randomized trial of the BESST intervention versus usual care 
in rural patients who are referred to (and discharged from) VA-CCN mental health 
treatment settings. The results of our work will ultimately lead to the development of a 
key resource for rural VA facilities to use to keep patients who are referred to (and 
discharged from) VA-CCN mental health treatment settings involved in VA care and to 
prevent death by suicide. 
Note we report here only on the portion of the protocol that relates to the pilot 
RCT that is registered at clinicaltrials.gov at the number listed on the first page. 
Thus, pages 6-12 are intentionally excluded from the document as they pertain 
only to aims 1 and 2 of the larger project.

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Project Proposal, Phase 3, Aim 3 
To test our hypotheses as described above, we propose to conduct an assessor - blinded RCT 
comparing the BESST intervention plus standard care to standard care alone. We will enroll up 
to 25 patients who are 18 years or older and are being discharged from a VA-CCN mental 
health treatment setting. The primary aim is to determine whether the BESST intervention 
reduces suicidal ideation at one and three months after discharge.  The secondary aim is to 
evaluate the impact of the BESST intervention on other related 
measures of suicide risk including hopelessness, social connectedness, fatal/non-fatal 
suicide attempts and treatment engagement. 
Randomization: Prior to the start of study enrollment, the study team otherwise not involved in 
recruitment will independently prepare allocation cards using a permutated block schedule. The 
same study staff member will then put these prepared allocation cards into sealed, opaque, 
numbered envelopes. After obtaining consent and completing the baseline assessment (see 
description below), the study staff member 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 staff will notify the 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.  
Baseline Assessment 
    The study assessor will meet with each eligible patient as close to the time of discharge as 
possible. The study assessor will conduct the visit by phone or VA Video-Connect (VVC). The 
study assessor 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.    

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BESST Intervention Description: Patients assigned to the BESST intervention will receive the 
BESST Intervention plus the standard care.  The BESST intervention is an adaptation of the VA 
BIC intervention and designed to meet the unique needs of Veterans receiving care in a VA-
CCN mental health treatment setting (see BESST Manual).9-11 BESST can be delivered by a 
trained mental health staff member, such as a mental health nurse, social worker, psychologist, 
or psychiatrist.  The intervention targets the needs of patients who are being discharged from a 
higher-level care setting (e.g., acute inpatient, residential).  The intervention incorporates 
aspects of motivational interviewing (MI) techniques.  Because the intervention is intended to 
complement and enhance standard care, patients assigned to the BESST intervention will 
continue to have access to care (described below).  There are no restrictions on the types of 
treatments that patients may pursue after discharge from the VA-CCN mental health treatment 
setting.  
Brief Educational Intervention: Patients receive a one-hour, one-on-one, brief educational 
intervention on suicide prevention.  The session is performed by a intervention staff member. 
The intervention will be delivered virtually either by telephone or VVC. We expect that this visit 
will occur approximately within 1-2 weeks after study entry. Because the intervention staff 
member will not be able to visit with the patient in person because patients may be admitted to 
VA-CCN units across several states (e.g., NH, MA, ME, and CT), the staff member will send the 
patient any associated educational handouts as shown in the manual by U.S. mail. In addition, 
the handout will also be available to the patient through a Qualtrics survey link (web-based) 
which the intervention staff member will give to the patient at the time of the session. The 
Qualtrics survey platform is being used for the sole purpose of making sure that the patient can 
see the educational materials while the intervention staff member walks through them. The 
patient will not answer any questions on the survey link (i.e., the link contains no questions). 
The patient will not put in any personal information on the website (i.e., the link contains no 
mechanism to enter personal data or information). The Qualtrics survey link only contains 
uploaded educational materials that are generic to the prevention of suicide in a Veteran 
population. The survey link does not contain any PHI.  
The educational session is designed to meet the information needs of Veterans receiving VA-
CCN mental health care 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 intervention staff member 
for a total of seven contacts over the course of the three months after discharge.  At each of 
these contacts, the 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 contacts are designed to be highly interactive, allowing time 
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. 
Standard Care:  Regardless of study assignment, all patients will have access to standard 
care. This includes recommendations for mental health follow-up as deemed appropriate by the 
discharging treatment team. Patients may also be offered specific treatments to address their 
mental health symptoms after discharge. It is also conceivable that a patient may be on the High 
Risk for Suicide List. Patients on the High Risk for Suicide List receive enhanced oversight as 

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outlined in VA policy. This includes a requirement that the treating provider schedule the patient 
to be seen four times within the first 30 days following discharge. The primary care or mental 
health provider is also expected to tailor the patient’s treatment to address his/her unique risk 
factors for suicide. The suicide prevention coordinator places a pop-up flag in the medical 
record to alert providers of the patient’s high-risk status. The continued need for the patient to 
remain on the High Risk for Suicide List is reassessed by the suicide prevention coordinator. 
Finally, the treating provider is expected to complete a safety plan with the patient.  
Outcome Measures: As outlined in Table 2, 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.  
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). We will also collect diagnostic information using either the MINI 
International Neuropsychiatric Interview (MINI), which has been validated against the 
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 
(DSM). The MINI is a short, structured diagnostic interview that, on average, takes about 15 
minutes to administer.25 We will ask about any history of suicide attempts using the validated 
Columbia Suicide Severity Rating-Scale (C-SSRS).26  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).27-29  Patients will be asked about their current 
suicidal ideation (i.e., past week) at baseline and at the one-month and three-month follow-up 
Table 2: 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 
Hopelessness 
BHS 
0.87 – 0.93 
20 Items 
10 
X 
X 
X 
Self-Efficacy 
GSE 
0.76  - 0.90 
10 items 
3 
X 
X 
X 
Connectedness 
INQ-15 
0.89 – 0.91 
15 items 
5 
X 
X 
X 
Connectedness 
MSPSS 
12 items 
5 
X 
X 
X 
Engagement 
SRCS 
0.89 
17 items 
5 
X 
X 
X 
Suicide Attempts CSSR-S 
N/A 
7 items 
5 
X 
X 
X 
Substance Use 
TLFB 
N/A 
6 items 
2 
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; GSE = General Self-Efficacy Scale; 
INQ-15 = Interpersonal Needs Questionnaire-15; M = months; MSPSS: 
Multidimensional Scale of Perceived Social Support; N/A = Not applicable; SRCS: 
The Suicide-Related Coping Scale; TLFB = Timeline follow-back  
*Time is described in minutes

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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. The BSS may be a measure of risk of suicide.30 There is evidence that the BSS is 
measurement invariant across time.29  
Secondary Outcome (Patient Engagement): We will measure patient engagement in 
treatment at baseline and at follow-up assessments in two ways. First, we will examine 
healthcare utilization in the first three months after discharge. We will look at the amount of 
contact with mental health providers as well as the time to first mental health appointment 
after discharge. We will also evaluate evidence of disruptions of care such as 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.  To gather data 
regarding the patient’s sense of self-efficacy around managing their suicide risk after 
discharge, we will administer the validated Suicide-Related Coping Scale (SRCS).31 This 
SRCS includes 17 questions related to a patient’s perception of their ability to cope with 
suicidal thoughts. Each item is assessed using a 5-point Likert scale and the measure has 
been developed based on two studies of suicide prevention strategies conducted within 
Veteran populations. The scale includes two subscales including an External Coping 
subscale and an Internal Coping Subscale. Both subscales have shown good acceptable 
internal consistency. The two factors are also sensitive to change over time. Higher scores 
on the scale suggest better coping. In addition to the SRCS, we will also measure the 
patient’s general sense of self-efficacy using the General Self-Efficacy Scale (GSE).32 This is 
a valid scale of self-efficacy that is designed for the general population (12 years or older) 
and it has been tested in various countries.  
Secondary Outcome (Hopelessness):  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,33  Patients report 
on feelings about the future, loss of motivation, and future expectations.  Total scores range 
from 0 to 20, with higher scores suggesting more hopelessness. The BHS has good 
reliability and validity and is sensitive to change.28 There is some evidence that the BHS 
may be a measure of risk of suicide.28  
Secondary Outcome (Connectedness):  We will measure social connectedness using 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.34  The 
INQ-15 may be a measure of risk of suicide.35 In addition, we will add also administer the 
Multidimensional Scale of Perceived Social Support (MSPSS).36 The MSPSS is a 12-item self-
reported scale that is designed to ask about support from several sources including friends, 
family and significant other. The scale has been shown to have good internal and test-retest 
reliability as well as good validity. 
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.26  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 

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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.  
Secondary Outcome (Substance use): We will assess substance use at baseline and follow-
up assessments using a timeline follow-back approach. This method is commonly used in 
research studies to assess substance use patterns.37 
Study Design:  As shown in Figure 3 below, patients allocated to the BESST intervention will 
meet with the intervention staff around the time of discharge.  During this visit, the patients will 
receive a brief educational intervention. Depending on patient preference, this visit will occur 
over the phone (or VA Video Connect). 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).  
All patients (including patients randomized to the intervention) will have access to standard  
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. We anticipate that, in most cases, 
the baseline assessment will occur around the time of discharge. However, because 
patients will be recruited remotely, we anticipate that the baseline assessments may in 
some cases happen a few weeks after discharge.   Depending on patient preference, the 
independent outcome assessor will conduct the follow-up assessments in a private office on 
the WRJ VAMC campus, over the phone, or using VA Video Connect.  The assessors will 
be blinded to study assignment and the patients will be instructed to not reveal their status 
to the assessor. 
Because we are recruiting patients from a large geographic area (New Hampshire, Maine 
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.   
Statistical Analyses: We 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 
Figure 3. Schedule of Assessments and Interventions. 
Study 
Timeline 
D/C 
2 dy 
2wk 
1m 
6wk 
2m 
10wk 
3m 
Assessments 
A1 
A2 
A3 
Randomized 
Intervention + 
Standard Care 
Brief 
Educational 
Intervention
   Inter-
vention 
contact 
Inter-
vention 
contact 
Inter-
vention 
contact 
Inter-
vention 
contact 
Inter-
vention 
contact 
Inter-
vention 
contact 
Inter-
vention 
contact 
Randomized  
Standard Care 
Discharge 
planning 
per local 
policy 
Outpatient MH treatment as deemed clinically appropriate by the 
patient’s outpatient MH providers. 
BIC= VA Brief Intervention and Contact Program; D/C = discharge; dy = days; m = 
months; MH = Mental Health; T0, T1, T2 = assessment time points; wk = weeks 

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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.   
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. In the case of the pilot study of the BESST intervention in up to 
six patients, 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 at each follow-up 
using a two-sample t-test.  
    With regards to the RCT of the BESST intervention, we will use a generalized linear 
mixed model to assess for changes in continuous variables in the first three months after 
discharge. 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. Based on available evidence, 
we hypothesize that the BESST intervention plus standard care will lead to a significant 
reduction in suicidal ideation after discharge.  
Specific Aim 2: We will generate descriptive summary statistics (e.g., means and standard 
errors, medians) and graphical displays for our secondary outcomes of interest at baseline and 
at each of the follow-up assessments. In the case of the pilot study of the BESST intervention in 
up to six patients, 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 at each follow-up using a 
two-sample t-test.  
    With regards to the RCT of the BESST intervention, we will use a generalized linear mixed 
model to assess for changes in continuous variables in the first three months after discharge. 
We will calculate the associated 95% confidence intervals and P-values.  As with the BSS, 
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 define a P-value of < 0.05 to be statistically 
significant.  We will use the maximum likelihood ratio to account for any missing data. 
Based on available evidence, we hypothesize that the BESST intervention plus standard 
care will lead to a significant reduction in our secondary outcomes after discharge.  
    For the categorical measure of healthcare utilization, we will use chi-squared tests to 
compare findings between study arms. 
Specific Aim 3: We will not be powered to detect a statistically significant difference between 
study arms with regards to suicide deaths and suicide attempts. These events are very difficult 
to examine in a clinical trial. A study would need to recruit well over 1,000 patients. Because we 
assume that few events will be observed in either arm, we plan to summarize our results by 

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providing basic descriptive statistics regarding the number of events in each arm at one-and 
three-month follow-ups.   
 
Sample Size: Based on our prior work,9-11 we believe it is useful to choose suicidal ideation as 
our primary outcome. In our pilot study of VA BIC, 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, in our 
pilot RCT of VA BIC on a VA inpatient unit we were also able to detect a statistically significant 
difference in BSS scores in a sample of 19 enrolled Veterans. Therefore, we will have sufficient 
power in this current pilot RCT to show a significant improvement in suicidal ideation if we enroll 
up to 25 patients.  
 
Study Population and Recruitment 
We will coordinate with staff at the WRJ, Togus or Manchester VAMCs to gain lists of patients 
referred to or discharged from VA-CCN mental health treatment settings. Acquiring these lists is 
the most comprehensive and effective way to garner this group of patients. We may also 
coordinate with staff at the sites mentioned in staff meetings such as interdisciplinary rounds 
(IDR) to learn of eligible patients for our study. Once a patient has been identified, we will then 
go into the patient’s medical record to confirm eligibility criteria are met and to obtain contact 
information including telephone numbers and street addresses. In addition, if feasible, the staff 
may also inform the patient about our study and ask the patient’s permission for our study team 
to contact the patient to provide further information about the study. In this case, if permission is 
obtained, the staff member will document this information in the patient’s medical record. 
 
We will request a HIPAA waiver for screening purposes. For patients identified via medical 
records, study staff will mail them a brief letter explaining the study. We will then follow-up via 
phone approximately one week after mailing the letter. If patients are interested in the study, 
study staff will read a consent document to the patient, and the patient will decide whether they 
would like to participate. If they agree to participate, verbal consent will be obtained and 
recorded on the telephone consent document. For patients who are referred to us by treating 
mental health providers, we will call the patient to further discuss the study. The VA staff will 
document in the medical record that the patient has given permission for the study staff to 
contact the patient and to provide further information about the study. If the patients are 
interested in participating, study staff will complete the consent process via telephone or VVC. 
   In the case of the RCT, 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 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: 
• 
The patient was recently discharged from a VA-CCN mental health treatment setting  
• 
The patient is at risk for self-harm based on expressed symptoms such as suicidal 
ideation of any severity, suicide attempt, or self-harm or the patient has been 
diagnosed with a mental health condition that is a known risk factor for suicidal 
behavior (e.g., depression, substance use disorder). 
• 
Be a patient connected to the WRJ VAMC, the Togus VAMC, or the  
        Manchester VAMC;  

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• 
Be a Veteran; 
• 
Be 18 years or older;  
• 
Be able to speak English;  
 
Exclusion Criteria  
• 
Unable to provide informed consent;  
• 
We do not plan to enroll any potentially vulnerable populations including prisoners, 
institutionalized patients, or involuntarily committed patients.  
• 
Study physician deems the patient not clinically appropriate (e.g., patient is 
acutely, medically unstable). Note it is possible that a patient’s clinical status 
could improve to the point where a patient could be approached about the study. 
This decision will be left to the clinical discretion of the study PI.  
 
 
Informed Consent 
We are requesting an alteration of consent. Because we are recruiting patients from VA-CCNs 
that are located across several states (many of which are located at a sufficient distance from 
the WRJ VAMC), it is not feasible for us to recruit patients in person to obtain their written 
consent. Furthermore, we wish to mitigate potential delays in recruiting patients because the 
goal of the intervention is to address the needs of patients around the time of discharge. 
Therefore, we will only be able to recruit patients virtually and conduct the consenting process 
virtually. Because this is a minimal risk intervention, it is appropriate to obtain a telephone 
consent or consent via VA-Video Connect (VVC) from the patient, with plans to send them a 
copy of the consent form by U.S. mail. This approach also reduces the burden on the patient, 
especially if they do not have access to technology and could otherwise not participate in the 
study because they can’t sign a form electronically.  
 
Risks and Side Effects 
 
Potential Risks  
Because the study population is known to be at high risk for suicide and the study outcomes 
include suicidal ideation, suicide attempts, and suicide, we will treat these events as anticipated 
adverse events during the course of this study. We will also consider hospitalizations or 
emergency room for worsening psychiatric symptoms or suicidal behavior as anticipated 
adverse events.   
 
We fully expect that patients may report worsening suicidal ideation or suicidal behaviors at the 
study assessments (i.e., baseline, one-month, or three-month,) regardless of whether they are 
assigned to the intervention or control condition. In addition, patients who receive the 
intervention may report worsening suicidal ideation or suicidal behavior during an intervention 
visit. We also expect that patients could be seen in the emergency room or be hospitalized 
because of any of the aforementioned events. Thus, we anticipate for the patients to continue 
with the study unless the patient requests to be removed from the study. In addition, as 
described in our Safety Alert Protocol, the study staff will immediately follow the safety alert 
protocol in response to any reports of worsening suicidal ideation or behaviors. If deemed 
clinical necessary, the patient will be connected immediately with required clinical treatment.  All 
patients will continue to have access to standard-of-care of treatment during the study 
irrespective of their study assignment.  Furthermore, all patients may continue any treatments 
that they were getting as part of their routine care prior to enrolling in this study.   

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Additionally, the population that we will recruit for this study are also at higher risk for substance 
misuse because these are very common conditions among patients who are treated in acute 
inpatient or residential treatment settings. Therefore, we will treat substance misuse (e.g., 
alcohol use disorder) as well as admission to a detox facility as anticipated adverse events. 
Related to these concerns, we also expect that patients may be incarcerated, especially due to 
drug use, while participating in the study. We will capture this as an adverse event, and we will 
consider it to be anticipated, particularly if related to drug or alcohol use. No study-related 
procedures will be conducted while a patient is incarcerated. Participants may choose to 
continue with the study upon their release, under the discretion of Dr. Riblet. Dr. Riblet will 
determine together with the study staff whether the patient needs to be reconsented prior to 
continuing in the study. If any study visits occurs when the patient is incarcerated, the visit will 
be captured as “missed” (i.e., that particular visit will be skipped).     
Therapeutic Risks  
During the study, 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 each follow-up assessment.  In addition, patients who receive the intervention 
condition will also be exposed to these therapeutic risks at the intervention visits (brief education 
visit plus seven contact visits after discharge).  In some cases, patients can feel embarrassed, 
nervous, bored, or generally uncomfortable when they are asked to answer these types of 
questions.  However, because we have sufficient safeguards in place to mitigate these potential 
risks, we believe that the overall therapeutic risk from this study to enrolled patients is very low.   
Research Risk  
During the course of the study, we will collect from enrolled patients 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).  
Therefore, there is some risk that a patient’s confidentiality or protected health information could 
be compromised due to study participation.  As we have sufficient safeguards in place to 
mitigate this risk (see Protection Against Risk below), we believe the overall research risk in this 
study is very low. We will also make every effort to conduct study-related procedures in a 
private setting.  
Protection Against Risk  
Study Population Safety Risk  
At each study assessment time point (i.e., baseline and 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 receiving the intervention, patients may 
report worsening suicidal ideation or suicidal behavior in the context of the intervention visits.  
Regardless of whether the patient is receiving the intervention or is assigned to usual care 
alone, 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 outlines the process that study staff 
members will take in order to ensure the safety and well-being of all enrolled patients regardless 
of whether they are receiving the intervention or usual care alone. In the case that a safety alert 
is met, the research 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 evaluation of 

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the patient’s risk and determine the most appropriate next level of care for the enrolled patient.  
The next level of care may include psychiatric admission, emergency room referral, or an 
outpatient follow-up with the patient’s healthcare provider.  Please see the Safety Alert 
Protocol for a full description of all safety alerts and required actions by study staff members.   
Therapeutic Risk  
Patients will be given sufficient time to answer questions and complete visits in order to reduce 
any discomfort they may experience as part of being enrolled in the study.  Patients will also be 
made aware that if any of the questions make them feel uncomfortable, they should feel free to 
report this to the study staff member and have this concern addressed immediately.  At any 
point during a study visit, a patient can take a break or refuse to answer a question.  
Research Risk  
Every effort will be made to ensure that we maintain the privacy and confidentiality of the 
patient.  All in-person, 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 the research staff will have 
access to this locked cabinet.  
Benefits:   
All of the patients who participate in this study 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, some patients may receive the intervention in addition to 
standard care.  The intervention 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 discharge.  Although the intervention is adapted from a successful 
suicide prevention strategy (WHO BIC) and has also been studied in VA treatment settings,
it is unknown whether the intervention significantly reduces suicide risk after discharge 
relative to standard discharge practices in patients who access VA-contracted community 
care inpatient or residential treatment. The work from this proposed study will be able to 
more definitively address whether the intervention is an effective suicide-prevention strategy 
in patients who access VA-contracted community care inpatient or residential treatment.  
This is important, given that suicide remains an important problem in the Veteran population. 
Because the overall risks associated with this study are minimal and the anticipated benefits 
and knowledge to be gained are clinically relevant, there is sufficient reason to conduct this 
proposed 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 

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collected from the patient’s electronic medical record at three-month follow-up.  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 be able to access this locked cabinet. 
 
Multi-Site Study Concerns This project will be conducted at WRJ VAMC. All study procedures 
will be conducted by staff affiliated with the WRJ VAMC. While staff at the Togus VAMC or the 
Manchester VAMC may inform us of potential study subjects, these sites are not engaged in 
research per VA Policy No. 151-806.  The three VA facilities are also all members of the VA 
Institutional Review Board of Northern New England (VINNE). Therefore, we do not foresee any 
issues in conducting this phase of the work. 
 
Resources Available    
Dr. Riblet will oversee and lead this project with the help of research staff, which includes: 
• An interventionist (75% Year 2) 
• A research coordinator (50% Year 2) 
• A study assessor (75% Year 2) 
• Administrative support (25% Year 2) 
 
Subject Compensation:  
We will compensate enrolled patients as follows: baseline: $100; one-month follow-up: $100; 
and three-month follow-up: $100. We chose this payment schedule so that patients are 
sufficiently reimbursed for their time and effort in the study.  We will make every effort to 
compensate participants, however, if a participant refuses payment or does not provide the 
required information for payment purposes, study staff will pursue the following process:  In the 
event that the patient has completed all assessments and/or interventions, and still has not 
provided the required information to pay them, the study staff will make reasonable efforts to 
obtain the information from the patient. If the patient still does not provide the required 
information to be paid, we will classify this patient as “unable to be paid”. 
 
Privacy and Confidentiality: 
Please see Protection Against Risk above. 
 
Data and Safety Monitoring Plan 
Monitoring and Interim Analysis Plan: We will seek oversight for the RCT portion of our 
proposal. Specifically, we will request that the Dartmouth Data Monitoring Committee (DSMB). 
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. 
 
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. 

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Adverse events will be reported with continuing review. Information security or privacy incidents 
will be reported to the ISSO 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, hospitalizations or emergency room for worsening psychiatric symptoms or 
suicidal behavior, drug or alcohol relapse or admission to a detox facility, or imprisonment.   
 
Reasons for stopping assigned treatment and follow-up:  
We will consider that he following events are 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 patient if they are willing to continue 
with the outcome assessments but respect his/her wishes if he/she chooses to withdraw 
entirely from the study. 
 
 
 
References & Literature Cited  
 
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Yehia BR, Greenstone CL, Hosenfeld CB, Matthews KL, Zephyrin LC. The Role 
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Mattocks KM, Mengeling M, Sadler A, Baldor R, Bastian L. The Veterans Choice 
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