Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma Centers

NCT03297060 | Completed

• 1 other identifier: 1R01AA025914
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to conduct a fully powered Type III hybrid effectiveness-implementation trial to test the effectiveness of a comprehensive implementation strategy in increasing the implementation of SBIRT for alcohol and other drug use in pediatric trauma centers. Our implementation strategy is based on the Science to Service Laboratory (SSL), an approach developed by the SAMHSA-funded Addiction Technology Transfer Centers (ATTCs) that consists of the same three core elements (i.e., didactic training + performance feedback + leadership coaching) used in our Centers for Disease Control and Prevention (CDC) study. Based on feedback from the CDC study, two enhancements were made to the SSL strategy: 1) integration of the intervention into the electronic medical record as a means of improving SBIRT adherence; and 2) development of separate training tracks for nurses, social workers and organizational leaders to meet the unique needs of each group. In addition, we integrate counseling around the use of prescription pain relievers into the SBIRT intervention as an Exploratory Aim, since most pediatric trauma center patients are discharged on pain medication and patients with a history of AOD use are at elevated risk of opioid misuse. Utilizing a stepped wedge design, a national cohort of 10 pediatric trauma centers will receive the SSL implementation strategy. Data collection for this study relies on multiple sources. At six distinct time points, each of the 10 sites will provide retrospective data from EMR charts. A subset of adolescents will also report on fidelity of intervention delivery and linkage to care (i.e., continued AOD discussion and/or treatment with a primary care provider) 1 month post hospital discharge. In addition, nurses, social workers, and leaders from each pediatric trauma center will report on organizational readiness for implementation at three distinct time points. Results of this study will demonstrate that a highly scalable implementation strategy, adapted for pediatric trauma centers from the results of our mixed-methods implementation trial, will improve the fidelity (i.e., the consistency and quality) of SBIRT delivery in pediatric trauma centers.

Conditions

Alcohol Drinking

Keywords

Alcohol Screening

Outcome Measures

Primary Outcomes (1)

• Proportion of admitted injured adolescents receiving each element of the alcohol screening, brief intervention and referral to treatment (SBIRT) protocol

  SBIRT components will be collected through retrospective data abstraction of each site's electronic medical record to determine if admitted injured adolescent patients received the SBIRT components during the different phases of the study.

  54 months

Secondary Outcomes (2)

• Rate of readiness for organizational change within each institution

  9 months

• Percent of adolescents with screened positive for AOD use and who reported linkage to discussions about AOD with a health care provider within 30 days of discharge within 30 days of discharge

  30 days

Other Outcomes (1)

• Rate of discussion of appropriate pain medication use and medication disposal with patients who screen positive for alcohol or other drug use.

  9 months

Study Arms (2)

SSL Implementation Strategy

EXPERIMENTAL

Science to Service Implementation Strategy for SBIRT adherence

Other: SSL Implementation Strategy

Standard Care

NO INTERVENTION

Standard Care SBIRT services

Interventions

SSL Implementation Strategy OTHER

Science to Service Laboratory (SSL) is an approach developed by the SAMHSA-funded Addiction Technology Transfer Centers (ATTCs) that consists of didactic training + performance feedback + leadership coaching to improve SBIRT adherence within the pediatric trauma center

SSL Implementation Strategy

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age Admitted to a participating trauma service for an injury Screened positive for AOD use based on biologic testing or self-report on the alcohol screening tool (S2BI) Fluent in English Able to provide written assent and parent able to provide written consent.

You may not qualify if:

• Prisoner or in police custody Admitted due to suicide attempt Any acute conditions that would preclude provision of informed consent (i.e., acute psychosis, altered mental status, cognitive impairment).

Sponsors & Collaborators

• Rhode Island Hospital: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (6)

• Scott K, Mello MJ, Almonte G, Lemus EA, Bromberg JR, Baird J, Spirito A, Zonfrillo MR, Lawson K, Lee LK, Christison-Lagay E, Ruest S, Aidlen J, Kiragu A, Pruitt C, Nasr I, Maxson RT, Ebel B, Becker SJ. A qualitative process evaluation of SBIRT implementation in pediatric trauma centers using the Science to Service Laboratory implementation strategy. Implement Sci Commun. 2025 Jan 30;6(1):13. doi: 10.1186/s43058-025-00697-x.

  PMID: 39885597 DERIVED

• Mello MJ, Baird J, Spirito A, Scott K, Zonfrillo MR, Lee LK, Kiragu A, Christison-Lagay E, Bromberg J, Ruest S, Pruitt C, Lawson KA, Nasr IW, Aidlen JT, Maxson RT, Becker S. Adolescents' Perceptions of Screening, Brief Intervention, and Referral to Treatment Service at Pediatric Trauma Centers. Subst Use. 2024 Aug 21;18:29768357241272356. doi: 10.1177/29768357241272356. eCollection 2024 Jan-Dec.

  PMID: 39175910 DERIVED

• Mello MJ, Lee LK, Christison-Lagay E, Spirito A, Becker S, Bromberg J, Ruest S, Zonfrillo MR, Scott K, Pruitt C, Lawson K, Nasr I, Aidlen J, Baird J. Counseling for opioids prescribed at discharge of hospitalized adolescent trauma patients. Inj Epidemiol. 2023 Oct 23;10(Suppl 1):53. doi: 10.1186/s40621-023-00465-2.

  PMID: 37872639 DERIVED

• Mello MJ, Baird J, Bromberg JR, Spirito A, Zonfrillo MR, Lee LK, Christison-Lagay ER, Ruest SM, Pruitt CW, Lawson KA, Kiragu AW, Nasr I, Aidlen JT, Ebel BE, Maxson RT, Scott K, Becker SJ. Variability in opioid pain medication prescribing for adolescent trauma patients in a sample of US pediatric trauma centers. Trauma Surg Acute Care Open. 2022 Apr 26;7(1):e000894. doi: 10.1136/tsaco-2022-000894. eCollection 2022.

  PMID: 35558645 DERIVED

• Mello MJ, Becker SJ, Spirito A, Bromberg JR, Wills H, Barczyk A, Lee L, Pruitt C, Ebel BE, Zonfrillo MR, Nimaja E, Scott K, Kiragu A, Nasr IW, Aidlen JT, Maxson RT, Baird J. Screening Adolescent Trauma Patients for Substance Use at 10 Pediatric Trauma Centers. J Trauma Nurs. 2020 Nov/Dec;27(6):313-318. doi: 10.1097/JTN.0000000000000537.

  PMID: 33156244 DERIVED

• Mello MJ, Becker SJ, Bromberg J, Baird J, Zonfrillo MR, Spirito A. Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma Centers-a type III hybrid effectiveness-implementation trial. Implement Sci. 2018 Feb 22;13(1):35. doi: 10.1186/s13012-018-0725-x.

  PMID: 29471849 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Michael J Mello, MD, MPH

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which arm their institution has been assigned to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study utilizes a stepped wedge design.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 29, 2017
• Study Start: March 1, 2018
• Primary Completion: March 31, 2023
• Study Completion: July 30, 2024
• Last Updated: November 13, 2024

Record last verified: 2023-11

Locations

US (1)