Adolescents with a chronic medical condition (A-CMC) are more likely to misuse and initiate alcohol and other drugs (AOD) at younger ages compared to adolescents without CMCs. A-CMCs account for the majority of pediatric inpatient hospitalizations as A-CMCs are often admitted for an acute inpatient stay following an emergency department visit for an exacerbation of their disease. However, A-CMCs are not routinely screened for alcohol use in pediatric inpatient settings. Thus, the pediatric inpatient setting provides clinicians a critical, but missed, opportunity to universally screen for alcohol use among A-CMCs once medical concerns are stabilized. The current study addresses this gap in the care cascade by examining the workflow processes in an urban pediatric hospital's inpatient units, adapting Screening, Brief Intervention, and Referral to Treatment (SBIRT) to the population and setting, and identifying SBIRT implementation strategies to pilot in a single arm hybrid type III effectiveness-implementation trial. This research is attained via three Specific Aims. In Aim 1, the candidate will observe inpatient workflows and collaborate with a Partner Steering Committee (PSC) composed of hospital staff (e.g., clinicians, administrators, information technology), A-CMCs, and parents to adapt SBIRT delivery and intervention components for the inpatient setting and population. Aim 2 will involve continued partnership with the PSC, to select, specify, and prioritize a set of SBIRT implementation strategies ideally suited for the inpatient setting and population. Aim 3 will consist of a single arm pilot hybrid type III effectiveness-implementation trial that simultaneously tests the set of implementation strategies selected in Aim 2 (primary outcome) and the SBIRT intervention adapted in Aim 1 (secondary outcome). To conduct this research, the candidate, Dr. Summersett Williams, requires training in three key areas: 1) expert knowledge and application of intermediate and advanced IS methods, including implementation strategy selection and evaluation of implementation outcomes; 2) application of human- and equity-centered design methods, including intervention adaptation and usability testing; and 3) expert application of the learning health system model to improve the health of A-CMCs who engage in risky drinking through enhanced healthcare system performance. These training aims will be supported by Ann \& Robert H. Lurie Children's Hospital of Chicago and by the candidate's mentorship team. The mentorship team will be led by Primary Mentor Dr. Sara Becker, an expert in implementing SBIRT targeting risky drinking in pediatric health settings. The proposal will also be supported by Drs. Robert Garofalo, Lisa Kuhns, and Patricia Franklin, experts in intervention adaptation, human- and equity-centered design methods, and the learning health system model, respectively. Taken together, this research and career development plan will advance a significant public health issue by advancing access to evidence-based alcohol health services for a vulnerable pediatric population while launching Dr. Summersett William's career as an independent implementation scientist.
APPROACH Overview. This study has three specific aims. Aim 1a involves observations of the inpatient units' clinical workflows to conduct mixed-methods assessments focused on integration of SBIRT into EHR documentation procedures. Aim 1b involves HCD/ECD methodology, including Partner Steering Committee (PSC) assembly and ideation sessions. These sessions will focus on iterative co-creation of SBIRT adaption to the inpatient setting and pediatric population, and two interactive rounds of initial implementation field testing with end users in one inpatient unit. Aim 2 includes a partner-driven method to collaboratively identify, select, and prioritize SBIRT implementation strategies to test in a pilot trial. Aim 3 is a single arm pilot hybrid type III SBIRT effectiveness-implementation trial in which two inpatient units will receive the optimized strategies to integrate SBIRT into their treatment workflow. Specific Aims 1a and 1b: Months 1-18 Aim1a: Observations of Inpatient Workflows (Aim 1a: Months 1-6). The research team and I will complete 4 months of observations on two inpatient units (i.e., Division of Pulmonary and Sleep Medicine and Division of Nephrology) that identified as units of high need for SBIRT during my K12 project. Understanding clinical workflows is a crucial first step to improve the quality, safety, and efficiency of patient care delivery. Observations of clinical workflows enable quality improvement processes, provide a basis to compare and quantify workflow improvements through mixed-methods analysis, and promote a LHS by assessing a variety of clinical and real-world data. Under the guidance of Dr. Franklin, my research team and I will observe current clinical procedures for recording AOD screening data in the EHR to determine areas where SBIRT can be integrated into standard EHR documentation procedures. The research team and I will use the Clinical Workflow Analysis Tool (CWAT) during workflow observation. CWAT interfaces with the EHR by identifying workflow patterns, bottlenecks, and context of current AOD use screening. The investigators will access the CWAT through a department issued tablet to maintain logs of qualitative and quantitative data such as the timing, location, and duration of AOD use screening, clinicians providing the screening (attending physicians, nurse practitioners, social workers, physician assistants, or residents) and type of information logged in the EHR. The research team and I will also use components of the Health Equity Implementation Framework (HEIF) as an observation guide focusing on interactions between patients and clinicians (clinical encounters), current AOD use screening questions (current intervention) and the setting (context) to identify areas to strengthen accessibility and inclusion in the clinical workflow. Four trained research assistants will observe daily clinical procedures and meetings (e.g., patient intakes, rounds, history \& physical exams, case conferences etc.) in pairs for 5 hours three times weekly during high peak times in the units (9 - 2pm or 2pm - 7pm) for 16 weeks (240 hours per unit for a total of 480 hours). During months 4 and 5 Dr. Danny Wu and I will use the CWAT to take these data and generate interactive visualizations to help identify and interpret workflow patterns. The visualization design will follow Munzner's nested model53 and generate four visual analytic components, including task analysis, sequential pattern analysis, location analysis, and task-location analysis. This aim will culminate in a visual workflow map and narrative of key observations to inform discussion with the PSC in Aim 1b. Aim 1b: Collaborate with hospital partners using HCD/ECD methods to optimize SBIRT's fit for the inpatient setting (Aim 1b; Months 7-18). Building upon Aim1a, I will employ HCD/ECD methods to ensure fit between the intervention, population, and system (e.g., workflow processes and clinical context) in which SBIRT will be delivered (). This optimization process consists of two steps that will take 12 months. Step 1 involves assembling an interdisciplinary Partner Steering Committee (PSC, months 7-8) and step 2 includes ideation sessions (months 9-18) with the PSC. Each month, PSC members will meet for two hours. Step 1: Assembling an Interdisciplinary PSC (Months 7-8). I will assemble a PSC (N=18) that includes pediatricians (N= 1 attending, 1 resident), mental health clinicians (N= 1 psychiatrist, 1 psychologist), clinical administrators (N=2), social workers (N=2), nurses (N=2), and information technology (IT) EHR specialists (N=2) working in the inpatient setting as well as A-CMCs (N=3) and caregivers of A-CMCs (N=3) recruited from Lurie Children's Hospital. Potentially eligible hospital staff will be identified by reviewing an organizational chart at Lurie Children's Hospital to identify appropriate candidates based on position in the patient workflow and level of responsibility in the hospital. A-CMCs and caregivers of A-CMCs will be recruited via flyers posted in inpatient clinics, outpatient centers, surgical centers, and primary care locations (see Recruitment and Retention Plan). Drs. Becker, Kuhns, and Garofalo often recruit hospital patients, staff, caregivers, administrators, and clinicians, and the proposed numbers are highly feasible within the time allotted. Pediatricians, nurses, mental health clinicians, and social workers will be eligible to participate if they provide inpatient treatment to A-CMCs, whereas administrators and IT specialists must either oversee or be engaged in a workflow in which SBIRT is likely to be embedded: all inpatient clinicians, administrators, and staff must have been employed at Lurie Children's Hospital for at least one year. A-CMCs must be a) ages 12 - 18; b) have a history of inpatient hospitalization at Lurie Children's Hospital for a chronic medical condition (e.g., asthma, chronic kidney disease, etc); and c) speak primarily English. Caregiver inclusion criteria include: 1) legal guardian of an adolescent patient meeting the aforementioned criteria; 2) able to speak/read English; and 3) willing and able to provide informed consent/assent. There are no exclusion criteria to enhance generalizability and capture a diverse range of partner perspectives and preferences. In two initial meetings, I will provide the PSC with an overview of the risk of drinking among A-CMCs, visual depiction of the workflow map created in Aim 1a, and project specifics. Partners will be introduced to SBIRT via a brief video, a graphic representation, and demonstration. The video will emphasize evidence-based components of SBIRT: screening (S), brief intervention (BI), and referral to treatment (RT). I will describe the adaptable delivery elements of SBIRT that can be customized to the needs of the pediatric hospital setting (e.g., who delivers each element, when each element is delivered, how each element is delivered, how these elements are recorded and tracked in the EHR) and the pediatric population (e.g., what information to include in the BI specific to the population): these elements are elaborated in the sections below. Potential Adaptations. The "S" component of SBIRT will include the Screening to Brief Intervention Tool (S2BI), a core intervention component. The S2BI is a validated screening for youth which assesses past year use of drinking, marijuana, and nicotine: adolescents who report past year use of any of these three substances are asked their frequency of use of four additional substances. This screening tool has a reported sensitivity of 90% and specificity of 94% detecting any AOD use disorder. Adaptable elements for screening hospitalized pediatric patients include identifying when to screen (e.g., during admission or clinician-patient encounters during the inpatient hospitalization) and how to incorporate screening results in patients' BI, discharge, and follow-up plans with sensitivity to patient confidentiality. Furthermore, screening methods such as self-administration vs. clinician-administration, electronic linkage to patients' medical records through the EHR vs. manually entered by clinical staff, are adaptable elements that will be discussed during the ideation sessions. The investigators will also discuss other useful adjunctive clinical screenings (e.g., blood alcohol concentration, breathalyzer, and urine screen) to potentially adapt to the pediatric inpatient setting in routine practice. Lastly, the investigators will identify unit clinicians who will facilitate screening and determine communication channels among clinicians, staff, and families about AOD use screening results most appropriate for the population and the clinical setting. Under typical conditions, the "BI" is delivered to patients with a positive AOD screen56 and is a discussion using motivational interviewing (MI) principles that can range from 5 to 15 minutes depending on the severity of AOD use.56 The BI also typically follows a structured format to increase speed and efficiency. Potential adaptations to the BI may include 1) integrating BI scripts in the EHR for standardization in delivery and tracking, 2) identifying a clinician(s) on the unit (e.g., nurse, social worker, attending or resident pediatrician, psychologist, etc.) to deliver the BI, 3) creating tailored AOD use educational materials specific to the interplay between CMCs and AOD use. "RT" typically includes linkage to AOD use specific treatment. Refinements may include linkage to follow-up discussions about AOD use with the patient's primary care team in ambulatory treatment (i.e., the patient's medical home in outpatient settings). Furthermore, refinements specific to A-CMCs reporting mild-moderate and severe use on the S2BI may also include referrals to community clinics providing targeted AOD use treatment and specialized services (e.g., vocational support) relevant for A-CMCs. The goal of the initial semi-structured discussions with the PSC is to build a common understanding of SBIRT's core intervention components, not subject to adaptation, and components that may be refined. Initial discussions will also build a sense of collaboration among the cross-disciplinary PSC to set the stage for future ideation sessions. Feedback will be recorded and synthesized through thematic content analysis to present back to the PSC in subsequent ideation sessions. Thematic content analysis will consist of two independent coders (candidate and trained RA) using Dedoose software, to identify emergent themes regarding PSC suggestions and preferences for SBIRT adaptation. Coders will meet weekly to evaluate inter-rater reliability and consensus regarding coding discrepancies. Step 2: Ideation Sessions (Months 9-18). The PSC will then participate in 2 rounds of brainstorming, prototyping, and field testing possible SBIRT adaptation elements. Brainstorming Sessions (Months 9-11). The goal for these sessions is to generate a high quantity of ideas, characterized by flexibility and speed to create adapted SBIRT screening (S), brief intervention (BI), and referral to treatment (RT) prototypes. The PSC will review the visual workflow map created from the observations in Aim 1a and discuss their ideal workflows for SBIRT. During early prototype brainstorming, idea generation activities will include sketching, movement between ideas posted around a room, and creation of and interaction with rough physical prototypes to boost creativity and generate a large quantity of ideas (e.g., 10 ideas of adapted BI components tailored to the population and setting, in an hour-long brainstorming session as one recommended target). After brainstorming, preliminary ideas will be organized to combine elements of ideas in logical ways. This is best done visually (e.g., physically rearranging ideas on index cards) to reveal connections between ideas (e.g., electronic self-administered screening through an EHR-linked patient portal accessed through patients' smart phones or department issued iPads) or concepts (e.g., BI with a focus on psycho- and health education for A-CMCs). The research team will prompt the PSC with questions about accessibility and inclusion to identify whether preliminary ideas promote equity and balances in power dynamics within the inpatient setting. Prototyping Sessions (Months 12-14). The PSC then progresses to rapid prototyping of the S, BI, and RT adaptations-cycling between fast ideas, soliciting feedback from potential end-users (e.g., patients) in a convenient setting (e.g., Lurie Children's Hospital Youth Advisory Board), and incorporating that feedback to refine ideas and create new prototypes over 3 meetings. Meetings will include storyboarding (e.g., drawing the journey of the intended users (e.g., social workers and patients) interacting with the S, BI, and RT prototype, and role-playing (acting out the intended users' interactions with the S, BI, and RT prototype)). Field Testing Sessions (Months 15-18). After development, prototypes will be tested to solicit feedback from end-users in an iterative fashion (e.g., execution, evaluation, evolution) during two initial testing sessions in one inpatient unit with 5 patients in each testing round. During execution, one prototype will be implemented by 5 clinicians. Immediately following execution of the prototype, I will debrief with clinicians to get feedback. Additionally, participants will compete the four-item Intervention Appropriateness Measure (IAM). After each round, I will present feedback and results from the IAM to the PSC for further refinement of the prototype. This process will result in the establishment of an adapted SBIRT protocol that will delineate methods for SBIRT administration in inpatient units for A-CMCs. The adapted protocol will include provider procedures for: response review, discussion of patient SBIRT responses and follow-up treatment, and EHR documentation. The adapted SBIRT protocol will be used for the Aim 2 strategy selection and Aim 3 pilot implementation trial. Aim 2: Selecting Strategies using the Expert Recommendations for Implementing Change (ERIC) Taxonomy (Aim 2; Months 19-30). After completing the partner-engaged intervention adaptation process, the next steps are to 1) prioritize SBIRT barriers and facilitators, 2) select and solicit feedback on theory-driven strategies for SBIRT implementation, 3) define and prioritize SBIRT implementation strategies to test in a pilot trial. ERIC is a compilation of 73 discrete implementation strategies initially developed through a modified Delphi approach and widely used in the IS field. Engaging partners (e.g., pediatricians, hospital leaders, social workers, patients, and caregivers) in the identification, operationalization, and selection of implementation strategies is more likely to produce strategies that will be result in adoption and sustained implementation. The selection of strategies will address the needs of multiple audiences, as patients, clinicians, and hospital leadership each face unique barriers that influence SBIRT implementation. Partners will continue to meet once monthly for two hours for a total of 12 meetings in Aim 2 (\~24h total). Step 1: Prioritization of barriers and facilitators by PSC (Months 19-21, Meetings 1-3). I will introduce PSC members to the list of the barriers and facilitators identified in my prior work. Using a collaborative, team-based process, the PSC will first review the list of determinants and will vote whether to retain or remove each one (majority rules). The PSC will also have the opportunity to add new determinants to the list. Once the PSC has agreed upon the list of determinants, the PSC will review each one and provide a consensus rating of the determinant's importance to successful implementation on a scale from 1 (not at all important) to 5 (very important). I will guide this discussion to ensure that the PSC uses the full range of ratings and not only the extreme ends of the scale. The research team will broadly categorize implementation determinants as workflow-related (e.g., standardized documentation and orders), clinician-related (e.g., educational materials, ongoing trainings, social interactions between clinicians and unit leaders), patient-related (e.g., patient-clinician interactions, AOD use knowledge), or systems related (e.g., billing and insurance coverage). Step 2: Soliciting PSC feedback on implementation strategies (Months 22-27, Meetings 4-9). The research team will enter those barriers and facilitators rated by the PSC as "4 or 5" in terms of importance into the CFIR-ERIC Matching Tool, a widely used IS tool that facilitates the matching of determinants to appropriate implementation strategies. The matching tool provides a list of CFIR determinants identified (e.g., clinician knowledge and/or skill deficit) and ERIC strategies to consider (e.g., education and/or training). A common critique of the CFIR-ERIC matching tool is that it provides an exhaustive list of strategies with no clear prioritization or strategic direction in terms of ordering. I will therefore share the list of matched strategies with the PSC and will have the PSC collaboratively rate each of the strategies on two dimensions: (a) perceived impact (how impactful does the participant expect this strategy to be to promote SBIRT implementation?); and feasibility (how feasible does the participant think this strategy would be in the pediatric hospital setting?). Impact and feasibility will be rated on a scale from 1 (low) to 5 (high). Facilitators will also be reviewed by the PSC to determine if any strategies should be designed to capitalize on strengths in the pediatric hospital setting. New strategies generated by the PSC will undergo a similar process of rating in terms of impact and feasibility. Step 3: Defining implementation strategies (Months 28-30, Meetings 10-12). Following the PSC's generation and ratings of SBIRT implementation strategies, I will guide the PSC in obtaining consensus about which strategies are most essential and most feasible. I will then plot the strategies in a two-by-two matrix, with strategies rated as high/low in terms of both impact and feasibility. Those strategies that are ideal for prioritization are those rated as high impact and high feasibility. I will then work with the PSC to operationally define each discrete strategy viewed as high impact and high feasibility. Specifically, the PSC will be asked to specify strategies across seven dimensions: the actor(s) (e.g., who executes the strategy), action(s) (e.g., what the actors do), action target (e.g., AOD use screening), temporality (e.g., when to use the strategy), dosage e.g., (the frequency and time of each use), implementation outcomes (e.g., adoption), and theoretical justification (e.g., research literature) per Proctor et al. The final matrix will be used to pilot the strategies that were rated as high impact and high feasibility in the hybrid type III effectiveness-implementation trial. Aim 3: Single Arm Pilot Hybrid Type III Effectiveness-Implementation Trial Months 31-54. Pre-trial SBIRT integration into two pediatric inpatient workflows (Months 31-42). SBIRT will be integrated into two inpatient units. Inpatient units at Lurie Children's Hospital served 5,409 patients across 35 inpatient units in 2023. The hospital has approximately 358 beds with patients hospitalized for an average of 3 days. Informed by workflow observations (Aim 1a) and health record/EHR documentation refinements (Aim 1b), I will meet with secondary advisor, Dr. Allan Wu and the IT specialists from the PSC to integrate SBIRT into the two units' EHR systems. Additionally, I will partner with the clinical managers on each unit to develop an implementation plan for organization-level integration of SBIRT into the clinical workflow. Lurie Children's Hospital uses EPIC, which can be modified by adding new templates, flowsheets, checklists, and/or dot phrases to facilitate documentation. The Primary Mentor, Dr. Becker, has successfully used collaborative design principles to refine SBIRT documentation in the EHR in pediatric trauma centers and will guide the approach used here. I will meet with appropriate health data/IT specialists to determine a SBIRT documentation plan that will be followed by changes to the EHR interface to meet clinician needs. Meetings with IT specialists will also involve development of methods for the inpatient units to extract fully de-identified SBIRT outcome data from the EHR. Delivery of Partner-Identified Implementation Strategies (Months 43-54). In this phase, the investigators will pilot the SBIRT implementation strategies prioritized by the PSC in Aim 2, across the two inpatient units. Based on Dr. Becker's prior work implementing SBIRT in a national cohort of pediatric trauma centers, the investigators expect that our bundled implementation strategies at a minimum will consist of: (a) didactic training in SBIRT delivery; (b) performance feedback on the accuracy of the S, BI, and RT components of the model based on practice cases; (c) efforts to increase awareness of SBIRT via visual reminders and cues; and (d) ongoing monthly coaching of unit leadership to ensure that monitoring of SBIRT implementation is integrated into ongoing quality improvement protocols. Bundled strategies will be paired with integration of SBIRT into the EHR. Sources of data. Consistent with best practices for a type III hybrid trial, implementation outcomes will be primary and effectiveness outcomes will be secondary. Implementation data will be fully de-identified EHR data provided via data pulls from the two inpatient units, augmented via brief provider scales. Effectiveness outcomes will be collected via self-report from a subset of 50 A-CMCs receiving medical treatment in the two inpatient units who will be consented sequentially over 12 months (about one patient weekly). Eligibility: A-CMCs will be eligible for enrollment if they are: a) aged 12-18 years, b) hospitalized for their CMC in one of the two inpatient units; c) medically stable according to clinician; and d) screen positive for alcohol use on the S2BI. A-CMCs will be excluded if they are unable to consent due to medical or cognitive limitations at the time they are approached by research staff. If eligible and interested, a trained research assistant will obtain informed assent/consent from eligible A-CMCs and consent from their caregivers/legal guardians immediately preceding enrollment. Research with A-CMCs indicate that one-third report alcohol use. Lurie Children's Hospital provides inpatient services to an average of 155 patients per unit annually. The investigators expect 30% of those to screen positive for alcohol use on the S2BI from the two inpatient units (N=93); thus, the proposed enrollment numbers are feasible within the time allotted. Implementation outcomes. Implementation outcomes will include SBIRT reach, adoption, and equity, as well as brief measures of feasibility and acceptability. Reach. Reach is the extent to which A-CMCs receive the SBIRT intervention on each inpatient unit. It is calculated as the number of A-CMCs who actually receive SBIRT divided by all A-CMCs admitted to the unit over the 12-month pilot. The investigators will calculate unit-specific rates for % of A-CMCs screened with the validated screener, % of patients who received an indicated BI, % of patients who received an indicated RT. Adoption. Adoption is the extent to which the intended "deliverers" of SBIRT actually delivered it. It is calculated as the number of clinicians on the unit who delivered SBIRT to at least one A-CMC divided by the total number of clinicians on the unit who treated at least one A-CMC. Equity. Equity is the extent to which all A-CMCs receiving inpatient treatment have just opportunities to receive SBIRT. The investigators will test for differences in S, BI, and RT by documented race, ethnicity, mental health diagnosis, age, insurance type, and gender to determine if disparities exist based on these variables. This will determine the extent that SBIRT was implemented universally in the two units. Acceptability and feasibility. The investigators will collect brief measures of SBIRT feasibility and acceptability using the well-validated 4-item scales, the Feasibility of Implementation Measure (FIM) and Acceptability of Implementation Measure (AIM) from all clinicians in the two inpatient units prior to the launch of the SBIRT implementation strategies and 3- and 6-months post receipt of the implementation strategies. Effectiveness outcomes. The investigators will measure effectiveness (reduction in AOD use, linkage to AOD treatment) outcomes at hospital admission (baseline), 3- and 6-months post-discharge in 50 A-CMCs. AOD Use: Research assistant (RAs) will review the EHR for eligible A-CMCs who screen positive for alcohol misuse on the S2BI during their hospital admission. RAs will contact potential patients while they are hospitalized for assent/consent. Once patients are consented RAs will administer two single item questions (e.g., "In the last three months, how many days did the participant have a drink containing alcohol?"; "In a typical week (over the past 3 months), how many days did the participant have a drink containing alcohol?). For follow-up, RAs will contact patients via telephone/teleconference to administer and record patients' responses electronically in REDCap at 3- and 6-months post-discharge. Patients will answer the S2BI and two single questions to measure the extent to which they are using AOD in comparison to their baseline screening. Linkage to Treatment: During follow-up via telephone/teleconference, research staff will ask A-CMCs: while the participant was on the inpatient unit, did their clinician (specific role to be determined based on Aim 1b), ask them about their AOD use (Y/N), provide them with brief counseling about their AOD use (Y/N), recommend that they follow up with anyone about their AOD use post discharge (Y/N)? A-CMCs will also be asked, did they follow-up with anyone about their AOD use post-discharge (Y/N), and if so, with whom and for how many sessions. Data Analysis. Descriptive analysis of the outcomes will include means, frequency tables, histograms, and examination of distributions. When appropriate, statistical tests will be two-sided with level of significance at 0.05. Descriptive statistics will be explored (means, standard deviations, ranges) for all outcome variables to obtain preliminary indication of SBIRT implementation and effectiveness across the two inpatient units. H1. SBIRT reach will be at least 70% and clinician adoption will be at least 65%. Equity will be calculated by the degree to which measures of adoption and reach vary across patient groups (by age, race, ethnicity, gender, and insurance status). H2. Patient alcohol use days will decrease 10% across the two units following SBIRT implementation strategies. Mean comparisons at baseline, 3- and 6-month follow up will be used to test the SBIRT hypotheses in the effectiveness sample (N=50). Finally, exploratory analyses using multiple regression will be completed to identify predictors of SBIRT implementation outcomes over time, including inpatient unit characteristics such as number of clinicians, patient demographic variables such as biological sex, gender identity, age, race, ethnicity, and medical diagnosis. Sex as a biological variable will be a covariate in all analyses. I will employ multiple imputation methods in the event of substantial missing data. Analyses are elaborated in the Statistical Design and Power attachment in the Clinical Trials section. Rigor and Reproducibly. Study procedures have been carefully designed to ensure rigor and reproducibility of results. The study protocol and intervention manual will include a high level of detail for transparency and reproducibility. The proposed research meets expectations for scientific rigor in the hybrid type III implementation effectiveness design, and the unbiased methods for data collection include standard and validated measures of AOD use. I will follow recommendations of the Standards for Reporting Implementation Studies (StaRI) Statement for reporting results and for thoroughness and transparency and make available the intervention protocol and manual to promote replication.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a widely endorsed EBP for detection and early intervention of risky drinking in adolescents.8,9 The goal of the SBIRT model is to employ universal screening (S) to identify adolescents at risk of alcohol use disorders, administer appropriate brief intervention (BI), and initiate referral to treatment (RT).8,9 NIAAA, the American Academy of Pediatrics (AAP), and the scientific community have widely endorsed the SBIRT model as an intervention that should be implemented across pediatric ambulatory and ED settings to prevent and reduce alcohol use among adolescents.35-40 The potential of SBIRT has been illustrated through multiple studies in both adolescent healthcare settings.8,9 Use of SBIRT is included in the guidelines for AOD use disorder treatment by the AAP, with recently published guidelines recommending that SBIRT be routinely used with A-CMCs.35
Reach of SBIRT Among Adolescents With Complex Medical Conditions (Proportion Receiving SBIRT Over 12 Months)
Reach will be assessed as the proportion of admitted adolescents with complex medical conditions (A-CMCs) on each inpatient unit who receive each SBIRT component over the 12-month pilot period. For each unit, we will calculate: (a) percentage of A-CMCs screened with the validated S2BI screener, (b) percentage who receive an indicated brief intervention (BI), and (c) percentage who receive an indicated referral to treatment (RT), summarized as proportions with 95% confidence intervals
Time frame: 12-month implementation period on each inpatient unit.
Adoption of SBIRT by Inpatient Clinicians (Proportion of Clinicians Delivering at Least One SBIRT Encounter Over 12 Months)
Adoption will be assessed as the proportion of clinicians on each inpatient unit who deliver SBIRT to at least one A-CMC during the 12-month pilot period. The numerator is the number of clinicians documented as delivering SBIRT to ≥1 A-CMC, and the denominator is the number of clinicians who treated ≥1 A-CMC on that unit; results will be summarized as proportions by unit.
Time frame: 12-month implementation period on each inpatient unit.
Feasibility of SBIRT Implementation Assessed by the Feasibility of Implementation Measure (FIM)
Feasibility will be measured using the 4-item Feasibility of Implementation Measure (FIM), a validated Likert-type clinician-reported scale. All clinicians on the two inpatient units will complete the FIM at baseline (pre-implementation) and at 3 and 6 months after implementation; scores (range and scoring rules as per FIM) will be summarized as mean (SD) and change over time.
Time frame: Baseline (pre-implementation) and 3 and 6 months after implementation start.
Acceptability of SBIRT Implementation Assessed by the Acceptability of Implementation Measure (AIM)
Acceptability will be measured using the 4-item Acceptability of Implementation Measure (AIM), a validated Likert-type clinician-reported scale. Clinicians will complete the AIM at baseline and at 3 and 6 months post-implementation; scores will be summarized as mean (SD) and change over time.
Time frame: Baseline (pre-implementation) and 3 and 6 months after implementation start.
Alcohol and Other Drug Use Among A-CMCs (Number of Days of Alcohol Use and S2BI Score at Baseline, 3 Months, and 6 Months)
Alcohol and other drug (AOD) use will be assessed among 50 A-CMCs who screen positive on the Screening to Brief Intervention (S2BI) tool at hospital admission. At baseline, 3 months, and 6 months post-discharge, research staff will administer the S2BI and two single-item questions ("In the last 3 months, how many days did you have a drink containing alcohol?" and "In a typical week over the past 3 months, how many days did you have a drink containing alcohol?"); responses will be summarized as S2BI category and mean number of drinking days at each time point and change from baseline.
Time frame: Hospital admission (baseline) and 3 and 6 months post-discharge.
Linkage to Alcohol and Other Drug Treatment (Self-Reported Receipt of Counseling and Follow-up Services by 6 Months)
Linkage to treatment will be measured via participant self-report at 3 and 6 months post-discharge. A-CMCs will be asked whether, during the index hospitalization, a clinician asked about AOD use (yes/no), provided brief counseling (yes/no), or recommended follow-up care (yes/no), and whether they attended any follow-up visits for AOD concerns (yes/no, type of provider, and number of sessions); we will summarize these as proportions linked to any treatment and mean number of sessions.
Time frame: 3 and 6 months post-discharge from the index hospitalization.
Alcohol-Related Problems Assessed by the Rutgers Alcohol Problem Index (RAPI)
Alcohol-related problems will be assessed using the Rutgers Alcohol Problem Index (RAPI), a self-report questionnaire measuring the frequency of alcohol-related consequences in adolescents. Scores will be summarized as total RAPI score (and, if desired, subscale scores) at each assessment point and change from baseline.
Time frame: Hospital admission (baseline) and 3 and 6 months post-discharge.
Alcohol Consumption Assessed by the Timeline Followback (Average Drinks, Binge Days, and Maximum Drinks Per Occasion)
Alcohol consumption will be measured with the Timeline Followback (TLFB), which assesses daily alcohol use over a specified recall period. Outcomes will include average number of drinks per drinking day, number of binge-drinking days, and maximum number of drinks consumed on a single occasion during the recall window; each metric will be summarized at each assessment point and change from baseline.
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Time frame: Hospital admission (baseline, covering the 3 months prior to admission) and 3 and 6 months post-discharge (each covering the prior 3-month period).