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

Primary Purpose

Alcohol Drinking

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SSL Implementation Strategy
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Drinking focused on measuring Alcohol Screening

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

-

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SSL Implementation Strategy

Standard Care

Arm Description

Science to Service Implementation Strategy for SBIRT adherence

Standard Care SBIRT services

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.)

Full Information

First Posted
September 8, 2017
Last Updated
April 10, 2023
Sponsor
Rhode Island Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03297060
Brief Title
Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma Centers
Acronym
IAMSBIRT
Official Title
Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma Centers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Alcohol Screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study utilizes a stepped wedge design.
Masking
Participant
Masking Description
Participants will not know which arm their institution has been assigned to.
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SSL Implementation Strategy
Arm Type
Experimental
Arm Description
Science to Service Implementation Strategy for SBIRT adherence
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard Care SBIRT services
Intervention Type
Other
Intervention Name(s)
SSL Implementation Strategy
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of admitted injured adolescents receiving each element of the alcohol screening, brief intervention and referral to treatment (SBIRT) protocol
Description
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.
Time Frame
54 months
Secondary Outcome Measure Information:
Title
Rate of readiness for organizational change within each institution
Description
Participating staff will complete organizational readiness for implementing change surveys throughout the study to identify if organizational readiness to change mediates implementation effectiveness
Time Frame
9 months
Title
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
Description
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.)
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Rate of discussion of appropriate pain medication use and medication disposal with patients who screen positive for alcohol or other drug use.
Description
Rates will be determined through EMR review (rates of documented opioid counseling).
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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). -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Mello, MD, MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35558645
Citation
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.
Results Reference
derived
PubMed Identifier
33156244
Citation
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.
Results Reference
derived
PubMed Identifier
29471849
Citation
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.
Results Reference
derived

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

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