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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03297060
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : April 12, 2018
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Rhode Island Hospital

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 data from 30 EMR charts (n = 1800 charts in total). 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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Other: SSL Implementation Strategy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study utilizes a stepped wedge design.
Masking: Single (Participant)
Masking Description: Participants will not know which arm their institution has been assigned to.
Primary Purpose: Health Services Research
Official Title: Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma Centers
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SSL Implementation Strategy
Science to Service Implementation Strategy for SBIRT adherence
Other: SSL Implementation Strategy
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

No Intervention: Standard Care
Standard Care SBIRT services

Primary Outcome Measures :
  1. Proportion of admitted injured adolescents receiving each element of the alcohol screening, brief intervention and referral to treatment (SBIRT) protocol [ Time Frame: 54 months ]
    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.

Secondary Outcome Measures :
  1. Rate of readiness for organizational change within each institution [ Time Frame: 9 months ]
    Participating staff will complete organizational readiness for implementing change surveys throughout the study to identify if organizational readiness to change mediates implementation effectiveness

  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 [ Time Frame: 30 days ]
    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.)

Other Outcome Measures:
  1. Rate of discussion of appropriate pain medication use and medication disposal with patients who screen positive for alcohol or other drug use. [ Time Frame: 9 months ]
    Rates will be determined through EMR review (rates of documented opioid counseling).

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Eligible adolescents must meet these criteria:

12-17 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.

Exclusion Criteria: Exclusion criteria include:

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03297060

Contact: Michael J Mello, MD, MPH 401-444-6684

United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Michael Mello, MD, MPH    401-444-2685   
Sponsors and Collaborators
Rhode Island Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Michael J Mello, MD, MPH Rhode Island Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rhode Island Hospital Identifier: NCT03297060     History of Changes
Other Study ID Numbers: 1R01AA025914 ( U.S. NIH Grant/Contract )
1R01AA025914 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rhode Island Hospital:
Alcohol Screening

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs