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Keywords: Objective: Patients who die by suicide are often seen in primary care settings in the weeks leading to their death.
Brief educational intervention There has been little study of brief interventions to prevent suicide in these settings.
Suicide prevention Method: We conducted a virtual, pilot, randomized controlled trial of a brief suicide prevention strategy called
Integrated care
Veterans Affairs Brief Intervention and Contact Program (VA BIC) in patients who presented to a primary care
Veteran
mental health walk-in clinic for a new mental health intake appointment and were at risk for suicide. Our pri
Remote research
mary aim was to assess feasibility. We measured our ability to recruit 20 patients. We measured the proportion of
enrolled patients who completed all study assessments. We assessed adherence among patients assigned to VA
BIC.
Results: Twenty patients were enrolled and 95% (N = 19) completed all study assessments. Among the 10 patients
assigned to VA BIC, 90% (N = 9) of patients completed all required intervention visits, and 100% (N = 10)
completed ≥70% of the required interventions visits.
Conclusion: It is feasible to conduct a virtual trial of VA BIC in an integrated care setting. Future research should
clarify the role of VA BIC as a suicide prevention strategy in integrated care settings using an adequately powered
design.
Clinical Trial Registration: NCT04054947.
1. Introduction death, and many of these were primary care (21%) or medical specialty
care (25%) contacts [3]. There is a critical need to identify effective
Suicide is the 10th leading cause of death for people of all ages in the strategies to prevent death by suicide in patients who have limited direct
United States (US) [1]. It is well-established that patients are at espe contact with the mental health care system.
cially high risk for suicide following an acute psychiatric hospitalization There have been two primary approaches to mitigate suicide risk in
[2]. However, there is also evidence to support that many patients who primary care settings. First, healthcare systems have focused on
die by suicide are seen in non-mental health settings such as primary educating primary care providers about suicide prevention, and
care in the weeks preceding their death [3,4]. Ahmedani et al. (2014) empowering these providers to address suicide risk [5,6]. Second,
found in an analysis of 4988 suicide deaths in patients enrolled in a healthcare systems have implemented collaborative care or integrated
Health Maintenance Organization (HMO) plan that almost 50% (2844) care models in the hopes that that these models will improve the man
of decedents had a health care contact in the four weeks prior to their agement of mental health symptoms and thereby, reduce suicide risk
* Corresponding author at: Veterans Affairs, Building 9, 215 North Main Street, White River Junction, VT 05009, United States of America.
E-mail address: Natalie.Riblet@dartmouth.edu (N.B. Riblet).
https://doi.org/10.1016/j.genhosppsych.2022.02.002
Received 22 December 2021; Received in revised form 14 February 2022; Accepted 15 February 2022
Available online 18 February 2022
0163-8343/Published by Elsevier Inc.
N.B. Riblet et al. General Hospital Psychiatry 75 (2022) 68–74
[5,7–11]. In a study of 20 primary care practices enrolled in the Pre evaluate new referrals using virtual care modalities including video and
vention of Suicide in Primary Care Elderly: Collaborative Trial (PROS telephone visits in response to the SARS-COV-2 pandemic physical
PECT), Bruce et al. (2004) found that depression treatment guidelines in distancing requirements. The policy remained in effect throughout the
conjunction with case management resulted in a significantly greater course of our study.
reduction in suicidal ideation compared with usual care [8]. The in The study was approved by our local Institutional Review Board and
vestigators, however, were unable to assess the impact of the interven was registered at ClinicalTrials.gov (Trial no. NCT04054947).
tion on suicide deaths because of the low event rate during the 24-month
follow-up [7]. In general, there is conflicting evidence about whether 2.2. Study design
educational interventions or collaborative/integrated care models are
effective at preventing suicide [6,9,12–14]. There are substantial bar Similar to other studies of VA BIC [22,23], we intended to use a
riers to bringing these approaches to scale because of time constraints combination of in-person and virtual methods to carry out this study.
[15,16] and limited or no access to mental health resources [17]. These However, consistent with clinical care, in-person research at our facility
concerns point to the need to identify feasible interventions that can be was put on hold due to the SARS-COV-2 pandemic. Therefore, we con
implemented in primary care settings to prevent suicide [5]. verted all study procedures including informed consent to a virtual
Surprisingly, unlike inpatient and emergency room settings [12,14], platform with approval from our local IRB. Patients were compensated
brief interventions to prevent suicide in primary care or integrated care for their participation.
settings have not been widely studied [18–20]. Dueweke (2019) con Patients were eligible for study inclusion if they were seen in the PC-
ducted a pre-post pilot study of a crisis planning intervention in 22 pa MHI clinic for a new mental health intake appointment, were at least 18
tients who presented with risk for suicide in an integrated care setting years old, English speaking, eligible to receive VA services, and were
[20]. They found that at four-month follow-up the intervention was currently at risk for suicidal behavior. We based our determination of
associated with lower suicidal intent, improved hope, and greater risk on the results of a formal suicide assessment scale (i.e., clinical
coping efficacy [20]. The World Health Organization Brief Intervention version of Columbia Suicide Severity Rating-Scale, C-SSRS) and clinician
and Contact (WHO BIC) program is a similarly promising suicide pre follow up questions of C-SSRS results documented in the intake note. We
vention strategy that has not been studied in primary care or integrated also allowed entry for patients when the clinician documented infor
care settings [21]. WHO BIC targets patients being discharged from an mation in their intake note to support that the patient may be at risk for
emergency room or psychiatric hospital after a suicide attempt (SA) and suicidal behavior. We relied on clinician interpretation of suicide risk
prevents suicide in this group [14,21]. The intervention begins at based on scale responses and other questioning rather than a set score
discharge with an educational session about suicide facts and suicide because of no clear cut off score criteria in the literature [27,28]. We
risk, motivation for treatment, and emphasis on self-efficacy and patient excluded patients who were unable to provide informed consent or
responsibility. It is followed by regularly scheduled telephone or in- imprisoned.
person contacts over 18 months [21]. An adapted version of WHO BIC The study staff screened new intake appointments in the PC-MHI
(called the Veterans Affairs Brief Intervention and Contact Program, VA daily to identify eligible patients. Patients who met inclusion criteria
BIC) has been developed for US veterans, and has shown promise in were sent a letter describing the study, and then received a follow-up
reducing suicide risk after psychiatric hospitalization [22,23]. VA BIC phone call to confirm study eligibility and to assess interest in partici
could be useful in primary care or integrated care settings because it pation. If interested, the study staff obtained informed consent
targets factors implicated in suicide risk during care transitions, telephonically.
including poor treatment engagement and social connectedness Using fixed block randomization, patients were randomly assigned to
[22–26]. VA BIC plus standard care or standard care alone. Study personnel who
In order to gather preliminary information on the role of VA BIC as a were not otherwise involved in recruitment or assessment indepen
suicide prevention strategy in primary care or integrated care settings, dently prepared allocation cards using sealed, opaque, sequentially
we conducted a pilot randomized controlled trial (RCT) of the VA BIC in numbered envelopes. It was impossible to blind either the interven
patients who presented to an integrated care setting for a new mental tionist or the patient to treatment allocation. However, the assessor
health evaluation. Our primary objective was to assess feasibility in the remained blinded to study assignment throughout the trial, and patients
integrated care setting. Our secondary objective was to collect pre were instructed not to reveal their assignment to the assessor.
liminary estimates of effect sizes. After obtaining consent, a trained assessor met with the patient to
conduct the baseline assessment. The assessor then conducted two
2. Method follow-up assessments at one- and three- months after the baseline
assessment. Because the research involves a high-risk population [29],
2.1. Sample patients received further evaluation by a study psychiatrist if their re
sponses met pre-defined criteria on a standardized safety protocol.
We conducted a pilot, single-site, assessor-blinded, RCT comparing
VA BIC plus standard care to standard care alone at the White River 2.3. Sample size
Junction Veterans Affairs Medical Center between August 2020 and May
2021. Patients were recruited from a collocated, collaborative care The primary aim of our pilot study was to determine the feasibility of
clinic, referred to as the Primary Care-Mental Health Integration Clinic conducting research on VA BIC in the integrated care setting. While an
(PC-MHI), located in the primary care clinic. The clinic is staffed by adaptation of WHO BIC was previously studied in VA populations at risk
prescribing clinicians including psychiatrists and advanced practice for suicide, those populations were exclusively inpatient samples
nurses as well as psychotherapists including psychologists and social [22,23]. Moreover, there was no prior literature in the VA or elsewhere
workers. PC-MHI providers work closely with primary care providers to on adapting WHO BIC to an entirely virtual format. There is a lack of
manage patients with a full spectrum of mental health conditions. In consensus about the optimal approach to determine a sample size for
most cases, patients are referred to the PC-MHI clinic for a same day, such a pilot study. Several strategies, however, have been proposed
one-time mental health consult. Patients then return to primary care for [30]. We followed guidance from the National Center for Complemen
ongoing care. tary Integrative Health at the National Institute of Health (NIH), which
Prior to the SARS-COV-2 pandemic, PC-MHI providers typically recommends against the use of a power analysis to determine a sample
evaluated new referrals in-person. However, in March 2020, the facility size for a pilot study, and suggests a researcher should select a sample
instituted a new policy whereby PC-MHI providers were expected to size that is both reasonable and feasible to achieve the stated objectives
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N.B. Riblet et al. General Hospital Psychiatry 75 (2022) 68–74
[31]. We set our target recruitment goal at 20 patients (i.e., 10 subjects the required intervention visits (i.e., brief education plus 4 or more
per group) because this sample size would provide us with reasonable contact visits). Finally, we reported any unanticipated challenges that
insights on the feasibility of studying VA BIC in an integrated care we observed in conducting research in patients at risk for suicide.
setting, and meet the budgetary constraints set by our funder. We also collected preliminary outcome data. We assessed suicidal
ideation using the Beck Scale for Suicidal Ideation (BSS) [34], and SAs
2.4. VA BIC intervention using the research version of the C-SSRS [35]. We assessed hopelessness
using the Beck Hopelessness Scale (BHS) [36]. We assessed social
Unlike the original WHO BIC, VA BIC is a manualized intervention connectedness in two ways. First, we used the validated Interpersonal
that includes conversation guides to facilitate the session [22,23]. VA Needs Questionnaire-15 (INQ-15) scale that measures thwarted
BIC was shortened to 3 months. These adaptations were made to help belongingness (TB) and perceived burdensomeness (PB) [37]. Second,
bring the program to scale in a clinical setting. we used the validated Multidimensional Scale of Perceived Social Sup
VA BIC aims to educate patients about suicide prevention, bolster port (MSPSS) [38]. The MSPSS assesses for overall support, and support
self-efficacy, and treatment engagement. A primary focus of the inter from a significant other, family, and friends [38].
vention is to encourage and facilitate treatment engagement and social We evaluated treatment engagement using a multidimensional
connection. It incorporates aspects of motivational interviewing. It can framework. First, we assessed self-management using the validated
be delivered by a trained mental health provider such as a psychologist, Partners in Health (PIH) scale [39]. Second, we measured the patient’s
social worker or mental health nurse [22,23]. The role of the interven ability to cope with suicidal behavior using the validated Suicide-
tionist can be best defined as that of a coach whose goal is to help pa Related Coping Measure (SRCM) scale [40]. The SRCM measures over
tients stay connected to their treatment. The sessions do not include all coping ability as well as external and internal coping ability. Third,
mental health interventions such medication management or psycho we measured intensity of treatment, defined as the total number of
therapy, rather it uses a standardized approach to encourage connection mental health and primary care visits between baseline assessment and
between the patient and the primary treatment team. the last study assessment. We abstracted utilization data from the VA
Once randomized to VA BIC, the patient was contacted by the electronic medical record and asked patients about use of non-VA care
interventionist by phone to briefly introduce them to VA BIC, and to using a standardized form.
schedule the brief education visit. A packet of printed educational ma
terials was mailed out to the patient in anticipation of the visit. The 2.7. Analysis
patients then received a one-hour, one-on-one educational intervention
on suicide prevention either over phone or video. As part of this session, We summarized baseline characteristics and measures of feasibility
the interventionist also introduced patients to safety planning. Patients using descriptive statistics. Using the intention-to-treat principle, we
then received six additional contacts with the interventionist over the developed a linear mixed-effects model to assess for differences in scores
course of three months. These visits occurred over phone or video. between study arms and across time, including one- and three-months
During these sessions, the interventionist checked on the patient’s well- post baseline assessment. We included treatment, time, and treatment-
being, encouraged self-monitoring of symptoms, affirmed progress, time interaction in the model. This approach allowed us to account for
reviewed the safety plan, assessed adherence with treatment, and any missing follow-up data, and adjust for any baseline differences in
continued to build the patient’s sense of self-efficacy and motivation for measures between study arms [41]. We compared health care utilization
treatment engagement. data across study arms using two sample t-tests. We conducted all ana
By design, the BIC program requires relatively little training [21]. lyses in R.
Prior to the start of the study, the interventionist (Dr. Susan Stevens), a We calculated preliminary effect sizes at each follow-up assessment.
clinical psychologist by training, was formally trained in the delivery of To account for the between-group design, we used a t-statistic to
VA BIC through didactics and video demonstrations. She completed calculate a Cohen’s ds as well as a Hedges’ gs [42]. We defined an effect
multiple practice cases to ensure competency. During the trial, she met size of 0.2 or less as small, 0.5 as medium, and 0.8 or greater as large.
with an expert in VA BIC (Dr. Natalie Riblet) on a regular basis to review
cases, and to receive ongoing supervision and mentoring. 3. Results
2.5. Standard care As shown in Supplementary Fig. 1, we were able to recruit 20 pa
tients into our study. This was 65% of available, eligible patients (N =
Regardless of assignment, all patients received the standard mental 31). Among the enrolled patients, 95% (N = 19) completed all study
health care that is offered to all patients who are seen for a new mental assessments. Furthermore, among the 10 patients who were assigned to
health evaluation in the PC-MHI clinic. This includes meeting with a VA BIC, 90% (N = 9) of patients completed all required intervention
mental health provider and completing a clinical assessment. The pro visits, and 100% (N = 10) completed 70% or more of the required in
vider works in collaboration with the patient to determine the appro terventions visits. One patient assigned to VA BIC was lost to follow-up
priate treatment regimen. Patients are usually referred to primary care after the fifth VA BIC contact visit, and therefore, missed the last VA BIC
for ongoing treatment. visit.
At study entry, patients on average reported mild symptoms of sui
2.6. Study measures cidal ideation and hopelessness as well as mild problems with social
connectedness and engagement (see Table 1). Patients assigned to VA
We collected socio-demographic data from participants using a BIC generally shared similar characteristics with patients assigned to
standardized intake form. We assessed baseline psychiatric diagnosis standard care. However, there were a few important differences.
using the MINI International Neuropsychiatric Interview (MINI) Compared to patients assigned to VA BIC, patients assigned to standard
[32,33]. We assessed feasibility in several ways. First, we measured our care were more often female (50% versus 20%), younger (mean age
ability to recruit 20 patients into the study. Second, we measured the 48.1 years (Standard Deviation, SD: 17.6) versus 54.9 years (SD: 17.1)),
proportion of enrolled patients who completed the baseline and two and had a lifetime history of a SA (50% versus 20%). Conversely, pa
follow-up study assessments. Third, we assessed adherence among pa tients assigned to VA BIC reported higher mean suicide-related coping
tients who were assigned to VA BIC. We measured both the proportion of scores than those assigned to standard care (mean 59.5(SD 21.9) vs 50.3
patients who completed all required intervention visits (i.e., brief edu (SD 12.7). Of note, the majority of patients reported a history of SA via
cation plus six contact visits), and those who completed 70% or more of overdose (e.g., aspirin). No SAs occurred within the three months prior
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N.B. Riblet et al. General Hospital Psychiatry 75 (2022) 68–74
Table 1 Table 2
Key characteristics of enrolled population*. A description of extra study contacts and related co-interventions that occurred
VA BIC Cohort (N Standard care (N =
among patients randomized to receive the VA BIC plus standard care or standard
= 10) 10) care alone.
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N.B. Riblet et al. General Hospital Psychiatry 75 (2022) 68–74
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N.B. Riblet et al. General Hospital Psychiatry 75 (2022) 68–74
contact with the study team outside of a priori scheduled study visits. assess the effect of VA BIC on suicidal behaviors, and to determine
Based on research safety standards such as alerting clinicians to whether baseline suicide risk modifies this effect. It is possible that
increasing scores on standardized assessments of suicidality, these pa primary care settings may benefit from selective prevention strategies
tients triggered the study safety protocol resulting in the patients that can target a broader population of at-risk patients Finally, we
receiving a set of interventions that were in addition to the typical observed that there were some important differences in patient char
standard of care. In most cases these interventions were greater intensity acteristics between VA BIC and standard care. For example, more
than VA BIC intervention. Specifically, the staff psychiatrist helped the women were in the standard care arm. There may be multiple unfore
patient with treatment engagement and notified providers of acute seen interactions between VA BIC, measures of social connectedness and
concerns. The providers implemented further interventions to address engagement, and gender. However, our study was not designed to
the patient’s acute symptoms, and these factors may have contaminated explore these hypotheses.
our results. Aligned with this concern, our study was conducted during
the SARS-COV-2 pandemic, and its related physical distancing re
strictions. It is possible that patients in the standard care arm may have 4.2. Conclusion
experienced unintended therapeutic benefit from the study assessments,
especially during times of social isolation. Several patients shared with It is feasible to conduct a virtual trial of VA BIC in an integrated care
study staff how much they appreciated speaking with the assessor even clinic. The intervention can be easily administered using a virtual plat
though our independent outcomes assessments were not designed to form. Future research should further clarify the role of VA BIC as a
have a therapeutic benefit. suicide prevention strategy in integrated care settings using an
Experts have emphasized that researchers face unique challenges in adequately powered design.
conducting suicide research [29]. Importantly, investigators must strike
a balance between the need for frequent assessments to ensure safety, Grant support and role of funder
and the risk that these frequent assessments may have unintended
therapeutic effects [29]. Certainly, an investigator must intervene in the This work was funded by the VA National Center for Patient Safety
case of acute suicide risk or other safety concerns [29]. Mental health Center of Inquiry Program, Ann Arbor, MI (PSCI-WRJ-Dr Shiner) and the
researchers may face additional challenges in studying behavioral VA Office of Rural Health, Veterans Rural Health Resource Center,
change interventions such as ours. There is concern that behavioral White River Junction VT (ORH 15532). Dr. Riblet has support from the
change interventions and assessments may interact and bias results [43]. Department of Veterans Affairs Clinical Science Research & Develop
Experts have found that assessments can be used to facilitate therapeutic ment Career Development Award Program (MHBC-007-19F). The sup
change [44]. These observations suggest that suicide researchers may porters had no role in the design, analysis, interpretation, or publication
need to consider alternative strategies that can effectively manage sui of this study. The views expressed in this article do not necessarily
cide risk during the course of a study, while also ensuring the integrity of represent the views of the Department of Veterans Affairs or of the
the research results. For example, one consideration may be decreasing United States Government.
the frequency of the assessment visits, or further standardizing the
management of patients who trigger safety protocols for concerning
CRediT authorship contribution statement
responses.
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N.B. Riblet et al. General Hospital Psychiatry 75 (2022) 68–74
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