Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03297060 |
| Other study ID # |
1R01AA025914 |
| Secondary ID |
1R01AA025914 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
July 30, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Rhode Island Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
