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临床试验/NCT07446075
NCT07446075尚未招募不适用

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

Faith Summersett Williams0 个研究点目标入组 50 人开始时间: 2028年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Reach of SBIRT Among Adolescents With Complex Medical Conditions (Proportion Receiving SBIRT Over 12 Months)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Pilot SBIRT among 50 A-CMCs aged 12-18 years in two inpatient units at a pediatric hospital.

Experimental

SBIRT arm

干预措施: Screening, Brief Intervention, and Referral to Treatment (SBIRT) (Other)

结局指标

主要结局

Reach of SBIRT Among Adolescents With Complex Medical Conditions (Proportion Receiving SBIRT Over 12 Months)

时间窗: 12-month implementation period on each inpatient unit.

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)

时间窗: 12-month implementation period on each inpatient unit.

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)

时间窗: Baseline (pre-implementation) and 3 and 6 months after implementation start.

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)

时间窗: Baseline (pre-implementation) and 3 and 6 months after implementation start.

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.

次要结局

  • Alcohol and Other Drug Use Among A-CMCs (Number of Days of Alcohol Use and S2BI Score at Baseline, 3 Months, and 6 Months)(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)(3 and 6 months post-discharge from the index hospitalization.)
  • Alcohol-Related Problems Assessed by the Rutgers Alcohol Problem Index (RAPI)(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)(Hospital admission (baseline, covering the 3 months prior to admission) and 3 and 6 months post-discharge (each covering the prior 3-month period).)

研究者

发起方
Faith Summersett Williams
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Faith Summersett Williams

Assistant Professor - Tenure Track

Ann & Robert H Lurie Children's Hospital of Chicago

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