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Alcohol DrinkingIAMSBIRTNCT03297060

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

A study testing SSL Implementation Strategy in people with Alcohol Drinking, run by Rhode Island Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Alcohol Drinking
What is being tested?
SSL Implementation Strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
430 participants
Where
1 siteUnited States
Study dates
1 Mar 2018to 30 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • 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).
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rhode Island Hospital

    Providence, Rhode Island, 02903

Other trials in United States

About this study

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.

Read the detailed description

In 2006, the American College of Surgeons (ACS) adopted a requirement for certification as a level one trauma center that mandated universal screening for alcohol misuse and delivery of a brief intervention for those screening positive1. Though this requirement has been mandated for a decade, its implementation has been challenging, especially for pediatric trauma centers. Our research team completed a CDC funded implementation study supporting seven pediatric trauma centers' compliance with the ACS requirement by developing and implementing an institutional alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol for adolescent trauma patients. A mixed-methods approach indicated that SBIRT adoption rates increased at all sites2; however, providers' fidelity to the SBIRT intervention was variable, and providers reported a number of barriers to SBIRT implementation. We have an unparalleled opportunity and an identified need to evaluate the effectiveness of a comprehensive SBIRT implementation strategy for alcohol and other drug (AOD) use across a national cohort of pediatric trauma centers.

The goal of this application is to conduct a fully powered Type III hybrid effectiveness-implementation trial to test the effectiveness of a comprehensive strategy in improving the implementation of SBIRT for AOD 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 CDC study. The SSL is an evidence-based strategy3,4 that provides leadership coaching focused on sustainability and that has potential for widespread dissemination throughout the ATTC network. The SSL was specifically designed to increase organizational readiness for implementation. 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 (EMR) 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 misuse5. 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 for review. 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 after 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 within pediatric trauma centers.

Primary Aim: Evaluate the effectiveness of the SSL implementation strategy in increasing fidelity of SBIRT delivery at pediatric trauma centers, relative to usual implementation.

Hypothesis: Staff that receive the SSL will increase by 20% the proportion of admitted injured adolescents receiving each element of the SBIRT protocol as indicated: a) validated AOD screening, b) brief AOD intervention, and c) referral to appropriate care post-discharge (i.e., continued AOD discussion/treatment with a health care provider).

Secondary Aim 1: Evaluate whether readiness for organizational change mediates the influence of the SSL implementation strategy on implementation effectiveness (i.e., fidelity of SBIRT delivery).

Hypothesis: The effect of the SSL on implementation effectiveness will be partially mediated by organizational readiness to change.

Secondary Aim 2: Evaluate the effect of the SSL implementation strategy on improving patient linkage to appropriate care (i.e., continued AOD discussion with primary care provider and/or AOD treatment) following discharge from pediatric trauma centers.

Hypothesis: Injured adolescents that receive the SSL will report higher rates of AOD discussion/treatment with a health care provider within 30 days of discharge, compared to usual implementation.

Exploratory Aim: Examine the integration of counseling regarding the use of prescription pain relievers into SBIRT delivery with injured adolescent patients who screen positive for AOD use.

Hypothesis: Staff that receives the SSL will demonstrate higher rates of discussion of appropriate pain medication use and medication disposal with patients who screen positive for AOD use, compared to usual implementation.

The proposed research builds on our prior implementation research and has potential to impact clinical care, address an important public health issue and significantly contribute to implementation science.

Being tested
SSL Implementation Strategy
Keywords
Alcohol Screening
Medical subject headings
Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSL Implementation StrategyOther

    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

Study groups in NCT03297060
Study groupRoleWhat they receive
SSL Implementation StrategyExperimentalScience to Service Implementation Strategy for SBIRT adherence
Receives: Other: SSL Implementation Strategy
Standard CareNo interventionStandard Care SBIRT services

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 54 months

Secondary outcomes (2)
  1. Rate of readiness for organizational change within each institution

    Participating staff will complete organizational readiness for implementing change surveys throughout the study to identify if organizational readiness to change mediates implementation effectiveness

    Measured: 9 months

  2. 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

    Patients will complete an online survey 30 days after discharge to determine linkage to appropriate care( i.e., continued AOD discussion with primary care provider and/or AOD treatment) following discharge from pediatric trauma centers.)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2017
  2. Study start1 Mar 2018
  3. Primary completion31 Mar 2023
  4. Study completion30 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
This study utilizes a stepped wedge design.
Masking
Single blind
Who is masked
Participant
Enrolment
430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03297060
Sponsor's protocol ID
1R01AA025914
Other IDs
1R01AA025914
Acronym
IAMSBIRT
Status last verified
Nov 2023
First submitted
8 Sep 2017
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zonfrillo MR, Baird J, Spirito A, Scott K, Lee LK, Kiragu AW, Christison-Lagay E, Bromberg JR, Ruest SM, Pruitt CW, Lawson KA, Nasr I, Aidlen J, Maxson RT, Becker SJ, Mello MJ. Comparing injury severity scores from trauma registries with those mapped from injury diagnosis codes in injured adolescents. Inj Prev. 2026 Mar 27;32(2):348-351. doi: 10.1136/ip-2024-045525.

    PubMed 41386800
  • 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.

    PubMed 39885597
  • 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.

    PubMed 39175910
  • 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.

    PubMed 37872639
  • 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.

    PubMed 35558645
  • 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.

    PubMed 33156244
  • 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.

    PubMed 29471849

Questions about this trial

What is this clinical trial studying?

A study testing SSL Implementation Strategy in people with Alcohol Drinking, run by Rhode Island Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of admitted injured adolescents receiving each element of the alcohol screening, brief intervention and referral to treatment (SBIRT) protocol (time frame: 54 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03297060, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

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