About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A-CMCs who screen positive for alcohol misuse on the S2BI during their hospital admission.
Disqualifiers
There are no exclusion criteria to enhance generalizability and capture a diverse range of partner perspectives and preferences.
Trial design
Single group
Treatments tested in this trial
Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Other interventionScreening, 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
Treatment groups
Trial outcomes
Primary outcomes
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
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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Faith Summersett Williams
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor institution
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