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Набор скоро начнётся NCT07446075

Bridging Opportunities for Substance Use Screening and Treatment for Teens With Chronic Illness

Без фазы С лечением Alcohol Misuse

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Screening, Brief Intervention, and Referral to Treatment (SBIRT).
Кому может быть актуально
Состояния в реестре: Alcohol Misuse. Базовые параметры: 12 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Adaptation and Implementation of SBIRT for Adolescents With Chronic Medical Conditions Hospitalized in Pediatric Inpatient Units

Обзор

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.

Подробное описание

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 patie

Вмешательства

  • Другое Screening, Brief Intervention, and Referral to Treatment (SBIRT)
    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

Первичные конечные точки

  • Reach of SBIRT Among Adolescents With Complex Medical Conditions (Proportion Receiving SBIRT Over 12 Months) [Срок оценки: 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) [Срок оценки: 12-month implementation period on each inpatient unit.]
  • Feasibility of SBIRT Implementation Assessed by the Feasibility of Implementation Measure (FIM) [Срок оценки: Baseline (pre-implementation) and 3 and 6 months after implementation start.]
  • Acceptability of SBIRT Implementation Assessed by the Acceptability of Implementation Measure (AIM) [Срок оценки: Baseline (pre-implementation) and 3 and 6 months after implementation start.]
Вторичные конечные точки (4)
  • Alcohol and Other Drug Use Among A-CMCs (Number of Days of Alcohol Use and S2BI Score at Baseline, 3 Months, and 6 Months) [Срок оценки: 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) [Срок оценки: 3 and 6 months post-discharge from the index hospitalization.]
  • Alcohol-Related Problems Assessed by the Rutgers Alcohol Problem Index (RAPI) [Срок оценки: 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) [Срок оценки: Hospital admission (baseline, covering the 3 months prior to admission) and 3 and 6 months post-discharge (each covering the prior 3-month period).]

Критерии участия

Критерии включения

  • A-CMCs who screen positive for alcohol misuse on the S2BI during their hospital admission.

Критерии исключения

  • There are no exclusion criteria to enhance generalizability and capture a diverse range of partner perspectives and preferences.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07446075 · STUDY00000381

Первоисточники (государственные реестры)

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