A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting

Abstract

Objective:

Patients who die by suicide are often seen in primary care settings in the weeks leading to their death. There has been little study of brief interventions to prevent suicide in these settings.

Method:

We conducted a virtual, pilot, randomized controlled trial of a brief suicide prevention strategy called Veterans Affairs Brief Intervention and Contact Program (VA BIC) in patients who presented to a primary care mental health walk-in clinic for a new mental health intake appointment and were at risk for suicide. Our primary 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

Suicide is the 10th leading cause of death for people of all ages in the United States (US) [1]. It is well-established that patients are at especially high risk for suicide following an acute psychiatric hospitalization [2]. However, there is also evidence to support that many patients who die by suicide are seen in non-mental health settings such as primary care in the weeks preceding their death [3,4]. Ahmedani et al. (2014) found in an analysis of 4988 suicide deaths in patients enrolled in a Health Maintenance Organization (HMO) plan that almost 50% (2844) of decedents had a health care contact in the four weeks prior to their death, and many of these were primary care (21%) or medical specialty care (25%) contacts [3]. There is a critical need to identify effective strategies to prevent death by suicide in patients who have limited direct contact with the mental health care system.

There have been two primary approaches to mitigate suicide risk in primary care settings. First, healthcare systems have focused on educating primary care providers about suicide prevention, and empowering these providers to address suicide risk [5,6]. Second, healthcare systems have implemented collaborative care or integrated care models in the hopes that that these models will improve the management of mental health symptoms and thereby, reduce suicide risk [5,7–11]. In a study of 20 primary care practices enrolled in the Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT), Bruce et al. (2004) found that depression treatment guidelines in conjunction with case management resulted in a significantly greater reduction in suicidal ideation compared with usual care [8]. The investigators, however, were unable to assess the impact of the intervention on suicide deaths because of the low event rate during the 24-month follow-up [7]. In general, there is conflicting evidence about whether educational interventions or collaborative/integrated care models are effective at preventing suicide [6,9,12–14]. There are substantial barriers to bringing these approaches to scale because of time constraints [15,16] and limited or no access to mental health resources [17]. These concerns point to the need to identify feasible interventions that can be implemented in primary care settings to prevent suicide [5].

Surprisingly, unlike inpatient and emergency room settings [12,14], brief interventions to prevent suicide in primary care or integrated care settings have not been widely studied [18–20]. Dueweke (2019) conducted a pre-post pilot study of a crisis planning intervention in 22 patients who presented with risk for suicide in an integrated care setting [20]. They found that at four-month follow-up the intervention was associated with lower suicidal intent, improved hope, and greater coping efficacy [20]. The World Health Organization Brief Intervention and Contact (WHO BIC) program is a similarly promising suicide prevention strategy that has not been studied in primary care or integrated care settings [21]. WHO BIC targets patients being discharged from an emergency room or psychiatric hospital after a suicide attempt (SA) and prevents suicide in this group [14,21]. The intervention begins at discharge with an educational session about suicide facts and suicide risk, motivation for treatment, and emphasis on self-efficacy and patient responsibility. It is followed by regularly scheduled telephone or in-person contacts over 18 months [21]. An adapted version of WHO BIC (called the Veterans Affairs Brief Intervention and Contact Program, VA BIC) has been developed for US veterans, and has shown promise in reducing suicide risk after psychiatric hospitalization [22,23]. VA BIC could be useful in primary care or integrated care settings because it targets factors implicated in suicide risk during care transitions, including poor treatment engagement and social connectedness [22–26].

In order to gather preliminary information on the role of VA BIC as a suicide prevention strategy in primary care or integrated care settings, we conducted a pilot randomized controlled trial (RCT) of the VA BIC in patients who presented to an integrated care setting for a new mental health evaluation. Our primary objective was to assess feasibility in the integrated care setting. Our secondary objective was to collect preliminary estimates of effect sizes.

2. Method

2.1. Sample

We conducted a pilot, single-site, assessor-blinded, RCT comparing VA BIC plus standard care to standard care alone at the White River Junction Veterans Affairs Medical Center between August 2020 and May 2021. Patients were recruited from a collocated, collaborative care clinic, referred to as the Primary Care-Mental Health Integration Clinic (PC-MHI), located in the primary care clinic. The clinic is staffed by prescribing clinicians including psychiatrists and advanced practice nurses as well as psychotherapists including psychologists and social workers. PC-MHI providers work closely with primary care providers to manage patients with a full spectrum of mental health conditions. In most cases, patients are referred to the PC-MHI clinic for a same day, one-time mental health consult. Patients then return to primary care for ongoing care.

Prior to the SARS-COV-2 pandemic, PC-MHI providers typically evaluated new referrals in-person. However, in March 2020, the facility instituted a new policy whereby PC-MHI providers were expected to evaluate new referrals using virtual care modalities including video and telephone visits in response to the SARS-COV-2 pandemic physical distancing requirements. The policy remained in effect throughout the course of our study.

The study was approved by our local Institutional Review Board and was registered at ClinicalTrials.gov (Trial no. NCT04054947).

2.2. Study design

Similar to other studies of VA BIC [22,23], we intended to use a combination of in-person and virtual methods to carry out this study. However, consistent with clinical care, in-person research at our facility was put on hold due to the SARS-COV-2 pandemic. Therefore, we converted all study procedures including informed consent to a virtual platform with approval from our local IRB. Patients were compensated for their participation.

Patients were eligible for study inclusion if they were seen in the PC-MHI clinic for a new mental health intake appointment, were at least 18 years old, English speaking, eligible to receive VA services, and were currently at risk for suicidal behavior. We based our determination of risk on the results of a formal suicide assessment scale (i.e., clinical version of Columbia Suicide Severity Rating-Scale, C-SSRS) and clinician follow up questions of C-SSRS results documented in the intake note. We also allowed entry for patients when the clinician documented information in their intake note to support that the patient may be at risk for suicidal behavior. We relied on clinician interpretation of suicide risk based on scale responses and other questioning rather than a set score because of no clear cut off score criteria in the literature [27,28]. We excluded patients who were unable to provide informed consent or imprisoned.

The study staff screened new intake appointments in the PC-MHI daily to identify eligible patients. Patients who met inclusion criteria were sent a letter describing the study, and then received a follow-up phone call to confirm study eligibility and to assess interest in participation. If interested, the study staff obtained informed consent telephonically.

Using fixed block randomization, patients were randomly assigned to VA BIC plus standard care or standard care alone. Study personnel who were not otherwise involved in recruitment or assessment independently prepared allocation cards using sealed, opaque, sequentially numbered envelopes. It was impossible to blind either the interventionist or the patient to treatment allocation. However, the assessor remained blinded to study assignment throughout the trial, and patients were instructed not to reveal their assignment to the assessor.

After obtaining consent, a trained assessor met with the patient to conduct the baseline assessment. The assessor then conducted two follow-up assessments at one- and three- months after the baseline assessment. Because the research involves a high-risk population [29], patients received further evaluation by a study psychiatrist if their responses met pre-defined criteria on a standardized safety protocol.

2.3. Sample size

The primary aim of our pilot study was to determine the feasibility of conducting research on VA BIC in the integrated care setting. While an adaptation of WHO BIC was previously studied in VA populations at risk for suicide, those populations were exclusively inpatient samples [22,23]. Moreover, there was no prior literature in the VA or elsewhere on adapting WHO BIC to an entirely virtual format. There is a lack of consensus about the optimal approach to determine a sample size for such a pilot study. Several strategies, however, have been proposed [30]. We followed guidance from the National Center for Complementary Integrative Health at the National Institute of Health (NIH), which recommends against the use of a power analysis to determine a sample size for a pilot study, and suggests a researcher should select a sample size that is both reasonable and feasible to achieve the stated objectives [31]. We set our target recruitment goal at 20 patients (i.e., 10 subjects per group) because this sample size would provide us with reasonable insights on the feasibility of studying VA BIC in an integrated care setting, and meet the budgetary constraints set by our funder.

2.4. VA BIC intervention

Unlike the original WHO BIC, VA BIC is a manualized intervention that includes conversation guides to facilitate the session [22,23]. VA BIC was shortened to 3 months. These adaptations were made to help bring the program to scale in a clinical setting.

VA BIC aims to educate patients about suicide prevention, bolster self-efficacy, and treatment engagement. A primary focus of the intervention is to encourage and facilitate treatment engagement and social connection. It incorporates aspects of motivational interviewing. It can be delivered by a trained mental health provider such as a psychologist, social worker or mental health nurse [22,23]. The role of the interventionist can be best defined as that of a coach whose goal is to help patients stay connected to their treatment. The sessions do not include mental health interventions such medication management or psychotherapy, rather it uses a standardized approach to encourage connection between the patient and the primary treatment team.

Once randomized to VA BIC, the patient was contacted by the interventionist by phone to briefly introduce them to VA BIC, and to schedule the brief education visit. A packet of printed educational materials was mailed out to the patient in anticipation of the visit. The patients then received a one-hour, one-on-one educational intervention on suicide prevention either over phone or video. As part of this session, the interventionist also introduced patients to safety planning. Patients then received six additional contacts with the interventionist over the course of three months. These visits occurred over phone or video. During these sessions, the interventionist checked on the patient’s wellbeing, encouraged self-monitoring of symptoms, affirmed progress, reviewed the safety plan, assessed adherence with treatment, and continued to build the patient’s sense of self-efficacy and motivation for treatment engagement.

By design, the BIC program requires relatively little training [21]. Prior to the start of the study, the interventionist (Dr. Susan Stevens), a clinical psychologist by training, was formally trained in the delivery of VA BIC through didactics and video demonstrations. She completed multiple practice cases to ensure competency. During the trial, she met with an expert in VA BIC (Dr. Natalie Riblet) on a regular basis to review cases, and to receive ongoing supervision and mentoring.

2.5. Standard care

Regardless of assignment, all patients received the standard mental health care that is offered to all patients who are seen for a new mental health evaluation in the PC-MHI clinic. This includes meeting with a mental health provider and completing a clinical assessment. The provider works in collaboration with the patient to determine the appropriate treatment regimen. Patients are usually referred to primary care for ongoing treatment.

2.6. Study measures

We collected socio-demographic data from participants using a standardized intake form. We assessed baseline psychiatric diagnosis using the MINI International Neuropsychiatric Interview (MINI) [32,33]. We assessed feasibility in several ways. First, we measured our ability to recruit 20 patients into the study. Second, we measured the proportion of enrolled patients who completed the baseline and two follow-up study assessments. Third, we assessed adherence among patients who were assigned to VA BIC. We measured both the proportion of patients who completed all required intervention visits (i.e., brief education plus six contact visits), and those who completed 70% or more of the required intervention visits (i.e., brief education plus 4 or more contact visits). Finally, we reported any unanticipated challenges that we observed in conducting research in patients at risk for suicide.

We also collected preliminary outcome data. We assessed suicidal ideation using the Beck Scale for Suicidal Ideation (BSS) [34], and SAs using the research version of the C-SSRS [35]. We assessed hopelessness using the Beck Hopelessness Scale (BHS) [36]. We assessed social connectedness in two ways. First, we used the validated Interpersonal Needs Questionnaire-15 (INQ-15) scale that measures thwarted belongingness (TB) and perceived burdensomeness (PB) [37]. Second, we used the validated Multidimensional Scale of Perceived Social Support (MSPSS) [38]. The MSPSS assesses for overall support, and support from a significant other, family, and friends [38].

We evaluated treatment engagement using a multidimensional framework. First, we assessed self-management using the validated Partners in Health (PIH) scale [39]. Second, we measured the patient’s ability to cope with suicidal behavior using the validated Suicide-Related Coping Measure (SRCM) scale [40]. The SRCM measures overall coping ability as well as external and internal coping ability. Third, we measured intensity of treatment, defined as the total number of mental health and primary care visits between baseline assessment and the last study assessment. We abstracted utilization data from the VA electronic medical record and asked patients about use of non-VA care using a standardized form.

2.7. Analysis

We summarized baseline characteristics and measures of feasibility using descriptive statistics. Using the intention-to-treat principle, we developed a linear mixed-effects model to assess for differences in scores between study arms and across time, including one- and three-months post baseline assessment. We included treatment, time, and treatment-time interaction in the model. This approach allowed us to account for any missing follow-up data, and adjust for any baseline differences in measures between study arms [41]. We compared health care utilization data across study arms using two sample t-tests. We conducted all analyses in R.

We calculated preliminary effect sizes at each follow-up assessment. To account for the between-group design, we used a t-statistic to calculate a Cohen’s d_s as well as a Hedges’ g_s [42]. We defined an effect size of 0.2 or less as small, 0.5 as medium, and 0.8 or greater as large.

3. Results

As shown in Supplementary Fig. 1, we were able to recruit 20 patients into our study. This was 65% of available, eligible patients (N = 31). Among the enrolled patients, 95% (N = 19) completed all study assessments. Furthermore, among the 10 patients who were assigned to VA BIC, 90% (N = 9) of patients completed all required intervention visits, and 100% (N = 10) completed 70% or more of the required interventions visits. One patient assigned to VA BIC was lost to follow-up after the fifth VA BIC contact visit, and therefore, missed the last VA BIC visit.

At study entry, patients on average reported mild symptoms of suicidal ideation and hopelessness as well as mild problems with social connectedness and engagement (see Table 1). Patients assigned to VA BIC generally shared similar characteristics with patients assigned to standard care. However, there were a few important differences. Compared to patients assigned to VA BIC, patients assigned to standard care were more often female (50% versus 20%), younger (mean age 48.1 years (Standard Deviation, SD: 17.6) versus 54.9 years (SD: 17.1)), and had a lifetime history of a SA (50% versus 20%). Conversely, patients assigned to VA BIC reported higher mean suicide-related coping scores than those assigned to standard care (mean 59.5(SD 21.9) vs 50.3 (SD 12.7). Of note, the majority of patients reported a history of SA via overdose (e.g., aspirin). No SAs occurred within the three months prior to study entry. In a few cases, the SA occurred ≥20 years ago.

Table 1.

Key characteristics of enrolled population*.

	VA BIC Cohort (N = 10)	Standard care (N = 10)
	N (%)	N (%)
Gender, female	2 (20.0)	5 (50.0)
Mean age (y, SD)	54.9 (17.1)	48.1 (17.6)
Demographic Variables
Race and Ethnicity
Black, Non-Hispanic	0 (0.0)	1 (10.0)
White, Non-Hispanic	1 (100.0)	7 (70.0)
White, Hispanic	0 (0.0)	1 (10.0)
Multiracial	0 (0.0)	1 (10.0)
Marital Status
Single	2 (20.0)	1 (10.0)
Divorced/Widowed/Separated	2 (20.0)	2 (20.0)
Married	5 (50.0)	5 (50.0)
Other	1 (10.0)	2 (20.0)
Baseline Clinical Characteristics
Number of Mental Health Conditions a
0–1 Mental Health Conditions	5 (50.0)	4 (40.0)
2–3 Mental Health Conditions	3 (30.0)	3 (30.0)
4+ Mental Health Conditions	2 (20.0)	3 (30.0)
Type of Mental Health Conditions
Depressive Disorders	6 (60.0)	8 (80.0)
Bipolar and Related Disorders	1 (10.0)	0 (0.0)
Anxiety Disorders	3 (30.0)	6 (60.0)
Trauma and Stressor Related Disorders	0 (0.0)	1 (10.0)
Obsessive Compulsive and Related Disorders	0 (0.0)	2 (20.0)
Substance Related and Addictive Disorders	1 (10.0)	1 (10.0)
History of Suicidal Behavior
Lifetime history of one or more SA, % (n)	2 (20.0)	5 (50.0)

Note: N = Number; % = percent; SA = Suicide Attempt; SD = Standard Deviation; VA BIC = Veterans Affairs Brief Intervention and Contact Program; y = year.

^aAs measured on the MINI International Neuropsychiatric Interview.

At follow-up, two out of the 10 patients assigned to standard care had extra contacts with the study personnel outside of the a priori study contacts (see Table 2). These contacts occurred because the patient’s responses to the study assessment triggered the study safety protocol. Patients received a range of co-interventions. Conversely, no patients assigned to VA BIC required extra contact with the study personnel at follow-up.

Table 2.

A description of extra study contacts and related co-interventions that occurred among patients randomized to receive the VA BIC plus standard care or standard care alone.

	VA BIC Cohort (N = 10)	Standard care (N = 10)
	N (%)	N (%)
Total patients	10 (100.0)	10 (100.0)
Patients with extra study contacts due to acute safety concernsa
Baseline assessmentb	1 (10.0)	0 (0.0)
First follow-up assessment	0 (0.0)	2 (20.0)
Second follow-up assessment	0 (0.0)	1 (10.0)
Co-interventions resulting from extra study contactsc
Total number of extra study contacts	1 (100.0)	3 (100.0)
Outpatient provider(s) notified of safety alert	1 (100.0)	3 (100.0)
Outpatient provider(s) scheduled a same-day or next-day visit with the patient	0 (0.0)	3 (100.0)
Outpatient provider referred the patient back to PC-MHI for further evaluation.	0 (0.0)	1 (33.3)
Patient was referred for ongoing psychiatric care in the mental health clinic	0 (0.0)	1 (33.3)
Patient was psychiatrically hospitalized	0 (0.0)	1 (33.3)

Note: N = Number; % = percent; PC-MHI = Primary Care - Mental Health Integration Clinic (PC-MHI), VA BIC = Veterans Affairs Brief Intervention and Contact Program.

^aThe study made use of standardized safety protocol. If the patient’s responses to the study assessments met pre-defined criteria, the patient had extra contact with study staff outside of the a priori study visits.

^bExtra study contacts occurred prior to randomization.

^cPatients were assessed by a study psychiatrist and additional steps were taken as necessary by the staff psychiatrist and outpatient provider to ensure the safety and well-being of the patient.

Data trends suggested that symptoms of suicidal ideation and hopelessness improved at one- and three-month assessment among the VA BIC group (see Table 3). The largest reduction occurred at three-months where scores fell by four points. At this level of improvement, patients denied suicidal ideation and hopelessness. The corresponding effect sizes for VA BIC were in the medium to large range for suicidal ideation (g_s = 0.71) and hopelessness (g_s = 0.60) (see Table 4). There was a medium effect on treatment engagement as measured by the number of non-VA BIC health care visits (mental health visits g_s = 0.43; primary care visits g_s = 0.55). No SA occurred during the study.

Table 3.

Outcomes at one and three-month follow-up among patients randomized to receive the VA BIC intervention plus standard care or standard care alone.

	VA BIC (N = 10)	Control (N = 10)	Between group differences
Outcome measures	Mean (SD)	Mean (SD)	Estimate
Suicidal Ideation (BSS)
Baseline	4.6 (11.7)	3.3 (6.7)	1.3
Follow-up (1 M)	1.2 (17.8)	2.0 (10.3)	−0.8
Follow-up (3 M)	0.7 (17.9)	3.5 (10.3)	−2.8
Hopelessness (BHS)
Baseline	6.6 (9.8)	6.5 (5.6)	0.1
Follow-up (1 M)	3.1 (13.8)	3.7 (8.0)	−0.6
Follow-up (3 M)	2.3 (13.9)	4.7 (8.0)	−2.4
Perceived Burdensomeness (INQ-15, PB)
Baseline	13.0 (17.1)	12.2 (9.9)	0.8
Follow-up (1 M)	9.8 (26.8)	10.8 (15.4)	−1.0
Follow-up (3 M)	11.9 (26.9)	9.1 (15.4)	2.8
Thwarted Belongingness (INQ, TB)
Baseline	28.6 (27.9)	35.2 (16.1)	−6.6
Follow-up (1 M)	24.2 (36.5)	26.9 (21.1)	−2.7
Follow-up (3 M)	22.4 (36.7)	24.4 (21.1)	−2.0
Self-Engagement (PIH)
Baseline	75.0 (29.9)	69.7 (17.3)	5.3
Follow-up (1 M)	82.1 (39.7)	81.0 (22.9)	1.1
Follow-up (3 M)	80.4 (40.0)	77.9 (22.9)	2.5
Overall Social Support (MSPSS)
Baseline	4.6 (3.5)	4.4 (2.0)	0.2
Follow-up (1 M)	5.4 (4.4)	5.2 (2.6)	0.2
Follow-up (3 M)	5.9 (4.5)	5.3 (2.6)	0.6
Support from Significant Other
Baseline	5.1 (3.9)	5.1 (2.2)	0.0
Follow-up (1 M)	6.2 (5.4)	5.8 (3.1)	0.4
Follow-up (3 M)	6.5 (5.5)	6.0 (3.1)	0.5
Support from Family
Baseline	4.7 (4.8)	3.5 (2.8)	1.2
Follow-up (1 M)	5.1 (5.6)	4.4 (3.2)	0.7
Follow-up (3 M)	5.8 (5.6)	4.3 (3.2)	1.6
Support from Friends
Baseline	4.0 (4.4)	4.7 (2.5)	−0.7
Follow-up (1 M)	5.0 (5.9)	5.4 (3.4)	−0.4
Follow-up (3 M)	5.3 (5.9)	5.5 (3.4)	−0.2
Overall Suicide-Related Coping (SRCM)
Baseline	59.5 (21.9)	50.3 (12.7)	9.2
Follow-up (1 M)	60.6 (29.6)	56.4 (17.1)	4.2
Follow-up (3 M)	63.6 (29.7)	58.2 (17.1)	5.4
External Suicide-Related Coping
Baseline	24.6 (9.9)	21.0 (5.7)	3.6
Follow-up (1 M)	24.8 (14.7)	24.1 (8.5)	0.7
Follow-up (3 M)	26.4 (14.8)	25.3 (8.5)	1.1
Internal Suicide-Related Coping
Baseline	24.4 (10.7)	20.7 (6.2)	3.7
Follow-up (1 M)	25.2 (13.6)	23.1 (7.9)	2.1
Follow-up (3 M)	25.8 (13.7)	22.6 (7.9)	3.2
Healthcare utilization over three- month assessment period
Total MH visits per patient	7.0 (5.6)	4.6 (5.3)	2.4
Total PCP visits per patient	3.3 (4.1)	1.6 (1.6)	1.7

Note: BHS = Beck Hopelessness Scale; BSS = Beck Scale for Suicidal Ideation; INQ = Interpersonal Needs Questionnaire; M = Month; MH = Mental Health; MSPSS = Multidimensional Scale of Perceived Social Support; N = Number; PB = Perceived Burdensomeness; PCP = Primary Care Provider; PIH = Partners in Health Scale; SD = Standard Deviation; SRCM = Suicide-Related Coping Measure; TB = Thwarted Belongingness; VA BIC = Veterans Affairs Brief Intervention and Contact Program.

Table 4.

Calculated effect sizes for VA BIC intervention plus standard care versus standard care alone.

Outcome measure	t-statistic	Cohen’s ds	Hedges’ gs	Favor VA BIC arm
Suicidal Ideation (BSS)
Assessment (1 M)	−0.86	−0.38	−0.0.37	Yesa
Assessment (3 M)	−1.65	−0.74	−0.71	Yesc
Hopelessness (BHS)
Assessment (1 M)	−0.39	−0.18	−0.17	Yesa
Assessment (3 M)	−1.39	−0.62	−0.60	Yesb
Perceived Burdensomeness (INQ-PB)
Assessment (1 M)	−0.48	−0.21	−0.21	Yesa
Assessment (3 M)	0.52	0.23	0.22	No
Thwarted Belongingness (INQ-TB)
Assessment (1 M)	0.91	0.41	0.39	No
Assessment (3 M)	1.06	0.48	0.46	No
Self-Management (PIH)
Assessment (1 M)	−0.88	−0.39	−0.38	No
Assessment (3 M)	−0.57	−0.26	−0.25	No
Overall Support (MSPSS)
Assessment (1 M)	0.13	0.06	0.06	Yesa
Assessment (3 M)	0.83	0.37	0.36	Yesa
Support from Significant Other
Assessment (1 M)	0.54	0.24	0.23	Yesa
Assessment (3 M)	0.64	0.29	0.28	Yesa
Support from Family
Assessment (1 M)	−1.05	−0.47	−0.45	No
Assessment (3 M)	0.65	0.29	0.28	Yesa
Support from Friends
Assessment (1 M)	0.49	0.22	0.21	Yesa
Assessment (3 M)	0.66	0.29	0.28	Yesa
Overall Coping with Suicidal Behavior (SRCM)
Assessment (1 M)	−1.38	−0.62	−0.59	No
Assessment (3 M)	−1.04	−0.47	−0.45	No
External Coping with Suicidal Behavior
Assessment (1 M)	−1.46	−0.65	−0.63	No
Assessment (3 M)	−1.24	−0.55	−0.53	No
Internal Coping with Suicidal Behavior
Assessment (1 M)	−1.04	−0.46	−0.44	No
Assessment (3 M)	−0.31	−0.14	−0.13	No
Healthcare utilization over three- month assessment periodd
Total MH visits per patient	−0.99	0.44	0.42	Yesa
Total PCP visits per patient	−1.23	0.55	0.52	Yesb

Note: BHS = Beck Hopelessness Scale; BSS = Beck Scale for Suicidal Ideation; INQ = Interpersonal Needs Questionnaire; M = Month; MH = Mental Health; MSPSS = Multidimensional Scale of Perceived Social Support; PB = Perceived Burdensomeness; PCP = Primary care provider; PIH = Partners in Health Scale; SRCM = Suicide-Related Coping Measure; TB = Thwarted Belongingness; VA BIC = Veterans Affairs Brief Intervention and Contact Program.

^aSmall effect.

^bMedium effect.

^cNearly large effect.

^dt-statistic calculated based on results from independent two-sample t-test.

Although other outcomes improved, the effects were generally less pronounced, and did not uniformly favor VA BIC. For example, patients assigned to standard care reported greater improvements in coping and thwarted belongingness than the VA BIC arm at three-month assessment.

4. Discussion

Our pilot work demonstrates that it is feasible to conduct a virtual trial of VA BIC in patients who present to an integrated care clinic for an initial evaluation of a mental health concern. Our experience suggest that VA BIC could either be implemented or studied in a formal research study in this setting using an entirely virtual format. Patient who are assigned to VA BIC appear to adhere to the intervention regimen consisting of one telehealth educational visit followed by six telehealth contact visits. VA BIC may benefit patients in integrated care settings by reducing suicidal ideation and decreasing hopelessness. These results, however, must be considered preliminary because of the limited samples size of this pilot study. Future research is needed to study the impact of VA BIC on suicide-related and other mental health outcomes in integrated care settings.

There have been several clinical trials of WHO BIC in low- and middle-income countries [14]. In addition, there have been several small studies of an adaptation of WHO BIC (i.e., VA BIC) in US veterans discharged from an inpatient mental health unit [22,23]. Together, these studies have suggested that the BIC program may be useful in reducing suicide risk after psychiatric discharge. There has been no study, however, of the BIC program in an integrated care setting. Unlike prior studies [14,22,23], our study enrolled patients with comparably milder symptom burden, and substantially less risk of suicidal behavior. Nevertheless, our preliminary findings suggested that in this population VA BIC may be associated with improvements in suicidal ideation and hopelessness. These results align with the limited body of research on brief suicide prevention strategies among patients at risk for suicide in primary care settings [19,20]. In a pre-post analysis of a crisis response planning intervention in patients assessed for moderate suicide risk in an integrated care setting, Dueweke (2019) also found that patients experienced some improvement in suicidal intent, hopelessness, and coping efficacy over a four-month period [20].

Overall, our findings suggested that it is feasible to study the VA BIC program in an integrated care setting. It is noteworthy, however, that 20% of patients in the control arm receiving standard care arm had extra contact with the study team outside of a priori scheduled study visits. Based on research safety standards such as alerting clinicians to increasing scores on standardized assessments of suicidality, these patients triggered the study safety protocol resulting in the patients receiving a set of interventions that were in addition to the typical standard of care. In most cases these interventions were greater intensity than VA BIC intervention. Specifically, the staff psychiatrist helped the patient with treatment engagement and notified providers of acute concerns. The providers implemented further interventions to address the patient’s acute symptoms, and these factors may have contaminated our results. Aligned with this concern, our study was conducted during the SARS-COV-2 pandemic, and its related physical distancing restrictions. It is possible that patients in the standard care arm may have experienced unintended therapeutic benefit from the study assessments, especially during times of social isolation. Several patients shared with study staff how much they appreciated speaking with the assessor even though our independent outcomes assessments were not designed to have a therapeutic benefit.

Experts have emphasized that researchers face unique challenges in conducting suicide research [29]. Importantly, investigators must strike a balance between the need for frequent assessments to ensure safety, and the risk that these frequent assessments may have unintended therapeutic effects [29]. Certainly, an investigator must intervene in the case of acute suicide risk or other safety concerns [29]. Mental health researchers may face additional challenges in studying behavioral change interventions such as ours. There is concern that behavioral change interventions and assessments may interact and bias results [43]. Experts have found that assessments can be used to facilitate therapeutic change [44]. These observations suggest that suicide researchers may need to consider alternative strategies that can effectively manage suicide risk during the course of a study, while also ensuring the integrity of the research results. For example, one consideration may be decreasing the frequency of the assessment visits, or further standardizing the management of patients who trigger safety protocols for concerning responses.

4.1. Strengths and limitations

We studied a highly promising brief suicide prevention strategy (VA BIC) in an integrated care setting. Although this population is at risk for suicide, little research has been done to understand the role of suicide prevention strategies in this setting. The virtual aspect of VA BIC may increase its applicability and scalability in primary care or integrated care settings. Concerns have been raised about the potential challenges posed by remote research during the SARS-COV-2 pandemic, but we had exceptional study retention and relatively good recruitment [45]. Although one patient assigned to VA BIC was lost to follow-up, the patient received more than 80% of the intervention components.

Our study has several limitations. First, we had a small sample size. As such, the study was not powered to detect statistically significant difference, and we cannot draw conclusions regarding whether VA BIC has any positive benefit on suicidal ideation or hopelessness in patients who are seen in an integrated care setting. Our study included veterans who access VA care. Because of the VA’s investment in mental health services, patients who access VA care may have better access to mental health treatment as compared to their civilian counterparts [46]. Second, most patients were of white race. While there were a few patients from underrepresented minority groups, these patients were all allocated to standard care. Third, we included a broad population of patients at risk for suicide, and the symptom acuity of enrolled patients was markedly lower than that of a comparable inpatient sample [23]. While this approach increased the generalizability of our findings, it made it more difficult to demonstrate meaningful differences in outcomes in such a small sample. Yet, despite this limitation, we did find that VA BIC was associated with medium to large effects on suicidal ideation. It may be useful in the future to conduct an adequately powered trial that can assess the effect of VA BIC on suicidal behaviors, and to determine whether baseline suicide risk modifies this effect. It is possible that primary care settings may benefit from selective prevention strategies that can target a broader population of at-risk patients Finally, we observed that there were some important differences in patient characteristics between VA BIC and standard care. For example, more women were in the standard care arm. There may be multiple unforeseen interactions between VA BIC, measures of social connectedness and engagement, and gender. However, our study was not designed to explore these hypotheses.

4.2. Conclusion

It is feasible to conduct a virtual trial of VA BIC in an integrated care clinic. The intervention can be easily administered using a virtual platform. Future research should further clarify the role of VA BIC as a suicide prevention strategy in integrated care settings using an adequately powered design.