Background
According to the World Health Organization, mental health and substance use disorders will surpass all physical diseases as a major cause of disability worldwide by 2020 [
1]. In the United States, the annual total estimated societal cost of substance use disorders is $510.8 billion [
2]. The negative outcomes and costs associated with substance use are not exclusive to any specific substance. For example, alcohol use is linked to significant economic and health costs on a global scale [
3]. It is often a contributing factor in homicides, suicides, crimes (violent, including homicide, and non-violent), motor vehicle collisions (non-fatal and fatal), and unintentional injuries to the drinker and others in his/her environment [
4]. Heavy drinking can lead to a pattern of abuse and/or dependence that is often associated with other harmful behaviors such as cigarette smoking, unsafe sex, and illicit drug use [
5]. Even lower levels of drinking, while potentially asymptomatic, are associated with health risks [
6].
In addition, despite a steady decline in smoking rates among the general population over the past several decades, tobacco use remains the primary known preventable cause of morbidity and mortality in the United States, resulting in an estimated 480,000 deaths annually from tobacco-attributable diseases [
7]. Quitting smoking has a greater impact on cardiovascular risk than changes in blood pressure, weight, physical activity, or lipids [
8]. Finally, and of particular relevance to the national public health and medical infrastructure in the United States, the rate of non-medical prescription pain reliever use reported in 2014 by US residents between the ages of 18–25 was 2.8% [
9]. Further, between 2004 and 2009, emergency department visits increased 98.4% in the US related to non-medical use of prescription drugs [
10]. These data have meaningful implications for the US healthcare system. Over 36.5 million adults are admitted annually to acute care hospitals in the US [
11]. In such settings, approximately one-third of adult patients screen positive for high-risk drinking or drug use [
12].
One promising public health response to this problem is screening, brief intervention, and referral to treatment (SBIRT), which is a comprehensive, integrated approach to the delivery of early intervention and referral to treatment services for persons at risk for or with substance use disorders and/or tobacco use and dependence [
13]. Rather than a specific, individual service, SBIRT is a patient care framework based on identifying risk via validated screening tools, intervening on that risk in a manner that is clinically appropriate, and referring to specialty treatment when the risk cannot be managed on-site [
14]. Data from a large cross-site evaluation from diverse healthcare sites (n = 754,525) indicate that most patients who screen positive are recommended for a brief intervention (BI 68.8%), followed by brief treatment (BT 14.0%) and referral to specialty treatment (RT 17.2%) [
15]. However, SBIRT screening in hospital settings tends to identify both a higher frequency of positive screens for alcohol and increased severity level of those screening scores, relative to outpatient primary care, indicating greater likelihood of patients needing referral [
16,
17].
The evidence basis for SBIRT is complex and varies considerably by type of substance, activity, and severity of use. Brief interventions (BI) for unhealthy alcohol use (‘misuse’) are supported by a systematic reviews [
18‐
20] as well as the largest SBIRT evaluation study to date [
15]. Alcohol BIs have also demonstrated efficacy for underage drinkers in the ED [
21]. However, alcohol BI does not appear to be efficacious for very heavy or dependent users [
22]. Further, a recent meta-analysis found no evidence that BI, naturally results in engagement with alcohol-related care [
23], though other researchers have disputed this claim [
24]. Few SBIRT studies focus specifically on outcomes from referral to treatment (RT) for alcohol [
25], sometimes due to difficulty disentangling the type of service provided [
26], though the cross-site evaluation from SAMHSA’s SBIRT initiative reported a moderate/large effect for RT [
15]. Due to this deficit in the literature, one research team recently conducted a proof-of-concept study for their alcohol RT, yielding promising results for patient engagement with treatment post-SBIRT [
27].
SBIRT for tobacco use provides a variety of intervention types ranging from minimal interventions (brochures) to BIs, nicotine replacement therapy (e.g., nicotine patches), and quit line referral. Evidence for these components has generally supported moderate effects on tobacco abstinence, especially for BI or BI with nicotine replacement [
7,
28‐
33]. Some of the research indicates that even minimal tobacco-centric interaction (less than a BI) may have an effect on abstinence [
29]. The specific effects of any given component or mixture of components continue to be under investigation, such as in a recent (2018) 16-arm factorial study protocol of tobacco SBIRT focusing on BI, nicotine replacement, quit line referral, and smoke-free text messaging [
34].
However, extant evidence supporting SBIRT for other substances is less well established. Some studies and reviews support SBIRT for other substances [
14,
35‐
39]. However, other recent studies found no evidence of efficacy for BI for other substances [
40‐
43], no evidence that BI for other substances reduces negative consequences of drug use [
44], and no evidence that BI [
43,
45] or RT [
42] for other substances increases receipt of treatment. A recent meta-analysis on this subject concluded that the current evidence basis is generally insufficient to make a determination [
46]. However, DiClemente’s review of reviews did find support of motivational interviewing (MI) for marijuana, while retaining the perspective of insufficient evidence for other substances (e.g., methamphetamine and opiates) [
18]. A recent, innovative modification of SBIRT, called STIRT (screening, treatment initiation, and referral to treatment), included revised protocols and medication-assisted treatment for opioid dependent patients. In a randomized trial, the authors reported increased engagement in opioid treatment and abstinence at 30 days compared to traditional SBIRT and control groups [
47].
The SBIRT process is a complex clinical process encompassing multiple components and activities, each of which are often not documented thoroughly, resulting in a body of literature that can be difficult to interpret. O’Donnell and colleagues identified a variety of papers pointing to a ‘lack of training or suitable intervention materials’ as one of several implementation-level barriers to SBIRT [
48]. Findings in the SBIRT literature are also mixed, and differentials in implementation strategies may also account for some of the variance in SBIRT trial outcomes [
18,
46]. One clear conclusion that can be drawn is that there is a need for randomized trials that thoroughly describe and test specific implementation methods. As a result, this proposed study will examine the impact SBIRT implementation on processes of care across rural, community and urban acute-care hospitals
In particular, this project challenges and seeks to shift current clinical practice paradigms within hospitals by examining the process outcomes associated with a standardized SBIRT process and workforce training toolkit for hospital nurses. Recent research has supported SBIRT training for nurses both as part of academic curricula [
49,
50] and as part of quality improvement [
51]. The extant patient flow within the hospital system selected for this trial has been responsive to the 2006 Institute of Medicine recommendation to coordinate mental health and substance use services with general health care [
52]. But even though hospitalized patients are asked about their substance use on admission, validated screening tools are rarely used, brief interventions are often not conducted, and referrals for treatment are not completed. A hospital admission offers an opportunity for nurses to identify and intervene with patients who are currently using substances at a time when they are already seeking professional care. The health system is therefore ideal for a cluster randomized mixed method approach testing the effectiveness of a toolkit on implementation of SBIRT.
Our prospective study is innovative and promising on multiple levels. It is likely that results will provide information that will support the standardization of both the SBIRT processes and mechanisms of workforce training to address a significant behavioral health problem (substance use) that can be deployed across the health system. This includes both the consistency of inpatient hospital screening and brief intervention and advancing community partnerships for referral to treatment and assessing long-term outcomes. As observed in prior literature, many complexities in interpreting current SBIRT literature result from non-standardized implementation and effectiveness efforts. Therefore, studying implementation is a crucial aspect of the protocol. This approach: (1) utilizes a conceptual framework that maximizes facility engagement in the adoption and implementation of SBIRT; (2) creates buy-in from key stakeholders through the use of a train-the-trainer approach; (3) generates outcome data to facilitate future innovations in practice; (4) produces a SBIRT toolkit with procedures, tools, instruments, implementation guide, and resources to disseminate and sustain SBIRT use; (5) employs an interprofessional team of researchers, educators, and clinicians; and (6) facilitates the adoption of SBIRT across the health system.
Our proposed study partners with a large health system in Indiana and aligns with the State of Indiana Substance Abuse Prevention and Mental Health Promotion Strategic Plan (2012–2017) [
53] by implementing SBIRT to improve the identification of people with at risk drug, alcohol or tobacco use, brief interventions and referral to treatment (when indicated). The short-term goal is to inform SBIRT implementation methods for use across rural, community and urban settings. The long-term goal is to develop an SBIRT toolkit with procedures, tools, instruments, implementation guide, and resources to disseminate and sustain SBIRT use to improve access to quality care and outcomes for people that use tobacco, non-prescription drugs, and/or drink an unhealthy amount of alcohol.
The purpose of this study is to examine SBIRT implementation methods across rural, community and urban acute hospital settings. The first aim is to test if implementation of SBIRT improves care delivery and referral of hospital inpatients currently using tobacco, alcohol or non-prescription drugs. The second aim is to evaluate the cost of SBIRT implementation and delivery for the healthcare system.
In US acute care settings, an estimated 1.8 million annual inpatient stays are primarily due to a behavioral health or substance use disorder [
54], despite concerted national efforts to reduce the prevalence and incidence of these risky behaviors. There remains an urgent need to advance behavioral health care practices using sophisticated and deliberative approaches to implementation. As this section has demonstrated, the phased cluster randomized approach of SBIRT described here is the next step to advance knowledge about how best to implement SBIRT and if implementation improves use of the SBIRT process moving forward.
Discussion
There are a number of strengths and limitations of this study related to the design, methods, and primary endpoints/outcomes. In terms of strengths, the use of a cluster randomized phased approach allows comparison of an intervention and control group, as well as within hospital differences before and after implementation of the intervention. It also allows both groups to participate in the intervention and implementation (providing data from 14 hospital unites to inform implementation guides for future use). Using a mixed method approach will provide data from multiple sources including observations, survey, interviews and secondary data from EMRs to inform the evaluation. The collection of organizational and implementation assessments will inform lessons from successful and ailed strategies with a specific focus on nurse barriers identified by Désy et al. [
68]. It is also important to note that this study is being conducted at a time when the opioid epidemic is a major public health priority and health systems are seeking better processes to identify and treat people with risky substance use.
Despite these strengths there are a number of limitations of the study including use of process endpoints instead of patient outcomes, the implementation process time/skill/resource demand, and use of the EMR data. The absence of patient clinical outcomes precludes the ability to evaluate if the intervention resulted in lower substance use, treatment success or patient experience. Given the current lack of strong evidence for SBIRT on such outcomes for all substances that are being targeted (e.g., drugs), a study linking SBIRT in medical units is needed. This study provides the first step toward studies of clinical outcomes by evaluating if this evidence-based practice is usable, implementable and if patients actually receive the care they should- and how to implement the intervention. Another limitation is the time demand in learning how to use and implement SBIRT given multiple priorities for clinical nurses. While projected time estimates were shared with nurse executives, and release time from clinical duties planned and budgeted in the grant were estimated, there is a learning curve and nurse staffing can vary day to day.
Use of medical record documentation to assess SBIRT consequences may also present a threat to study validity. Compliance with processes of care captured in EMR documentation is typically used to evaluate the quality of services rendered. There is a possibility that at baseline there may be nothing documented beyond the initial screening for substance use. Even after the education, implementation may require additional time and it may take longer than 6 months for practice to change. A nurse self-report of SBIRT use on the last admitted patient on randomly selected days will be included, providing data that can be used to correlate with the EMR data.
Authors’ contributions
RN, MJ, AG, GB, MF, DM, MJ, and RS made substantial contributions to conception and design. RN, MJ, JA, GB, MF, RS, and KT were involved in drafting the manuscript or revising it critically for important intellectual content. All authors gave final approval of the version to be published, and agreed to be accountable for all aspects of the work ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors read and approved the final manuscript.