<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03297060</url>
  </required_header>
  <id_info>
    <org_study_id>1R01AA025914</org_study_id>
    <secondary_id>1R01AA025914</secondary_id>
    <nct_id>NCT03297060</nct_id>
  </id_info>
  <brief_title>Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma Centers</brief_title>
  <acronym>IAMSBIRT</acronym>
  <official_title>Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma Centers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to conduct a fully powered Type III hybrid&#xD;
      effectiveness-implementation trial to test the effectiveness of a comprehensive&#xD;
      implementation strategy in increasing the implementation of SBIRT for alcohol and other drug&#xD;
      use in pediatric trauma centers. Our implementation strategy is based on the Science to&#xD;
      Service Laboratory (SSL), an approach developed by the SAMHSA-funded Addiction Technology&#xD;
      Transfer Centers (ATTCs) that consists of the same three core elements (i.e., didactic&#xD;
      training + performance feedback + leadership coaching) used in our Centers for Disease&#xD;
      Control and Prevention (CDC) study. Based on feedback from the CDC study, two enhancements&#xD;
      were made to the SSL strategy: 1) integration of the intervention into the electronic medical&#xD;
      record as a means of improving SBIRT adherence; and 2) development of separate training&#xD;
      tracks for nurses, social workers and organizational leaders to meet the unique needs of each&#xD;
      group. In addition, we integrate counseling around the use of prescription pain relievers&#xD;
      into the SBIRT intervention as an Exploratory Aim, since most pediatric trauma center&#xD;
      patients are discharged on pain medication and patients with a history of AOD use are at&#xD;
      elevated risk of opioid misuse. Utilizing a stepped wedge design, a national cohort of 10&#xD;
      pediatric trauma centers will receive the SSL implementation strategy. Data collection for&#xD;
      this study relies on multiple sources. At six distinct time points, each of the 10 sites will&#xD;
      provide retrospective data from EMR charts. A subset of adolescents will also report on&#xD;
      fidelity of intervention delivery and linkage to care (i.e., continued AOD discussion and/or&#xD;
      treatment with a primary care provider) 1 month post hospital discharge. In addition, nurses,&#xD;
      social workers, and leaders from each pediatric trauma center will report on organizational&#xD;
      readiness for implementation at three distinct time points. Results of this study will&#xD;
      demonstrate that a highly scalable implementation strategy, adapted for pediatric trauma&#xD;
      centers from the results of our mixed-methods implementation trial, will improve the fidelity&#xD;
      (i.e., the consistency and quality) of SBIRT delivery in pediatric trauma centers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2006, the American College of Surgeons (ACS) adopted a requirement for certification as a&#xD;
      level one trauma center that mandated universal screening for alcohol misuse and delivery of&#xD;
      a brief intervention for those screening positive1. Though this requirement has been mandated&#xD;
      for a decade, its implementation has been challenging, especially for pediatric trauma&#xD;
      centers. Our research team completed a CDC funded implementation study supporting seven&#xD;
      pediatric trauma centers' compliance with the ACS requirement by developing and implementing&#xD;
      an institutional alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT)&#xD;
      protocol for adolescent trauma patients. A mixed-methods approach indicated that SBIRT&#xD;
      adoption rates increased at all sites2; however, providers' fidelity to the SBIRT&#xD;
      intervention was variable, and providers reported a number of barriers to SBIRT&#xD;
      implementation. We have an unparalleled opportunity and an identified need to evaluate the&#xD;
      effectiveness of a comprehensive SBIRT implementation strategy for alcohol and other drug&#xD;
      (AOD) use across a national cohort of pediatric trauma centers.&#xD;
&#xD;
      The goal of this application is to conduct a fully powered Type III hybrid&#xD;
      effectiveness-implementation trial to test the effectiveness of a comprehensive strategy in&#xD;
      improving the implementation of SBIRT for AOD use in pediatric trauma centers. Our&#xD;
      implementation strategy is based on the Science to Service Laboratory (SSL), an approach&#xD;
      developed by the SAMHSA-funded Addiction Technology Transfer Centers (ATTCs) that consists of&#xD;
      the same three core elements (i.e., didactic training + performance feedback + leadership&#xD;
      coaching) used in our CDC study. The SSL is an evidence-based strategy3,4 that provides&#xD;
      leadership coaching focused on sustainability and that has potential for widespread&#xD;
      dissemination throughout the ATTC network. The SSL was specifically designed to increase&#xD;
      organizational readiness for implementation. Based on feedback from the CDC study, two&#xD;
      enhancements were made to the SSL strategy: 1) integration of the intervention into the&#xD;
      electronic medical record (EMR) as a means of improving SBIRT adherence; and 2) development&#xD;
      of separate training tracks for nurses, social workers and organizational leaders to meet the&#xD;
      unique needs of each group. In addition, we integrate counseling around the use of&#xD;
      prescription pain relievers into the SBIRT intervention as an Exploratory Aim, since most&#xD;
      pediatric trauma center patients are discharged on pain medication and patients with a&#xD;
      history of AOD use are at elevated risk of opioid misuse5. Utilizing a stepped wedge design,&#xD;
      a national cohort of 10 pediatric trauma centers will receive the SSL implementation&#xD;
      strategy. Data collection for this study relies on multiple sources. At six distinct time&#xD;
      points, each of the 10 sites will provide retrospective data from EMR charts for review. A&#xD;
      subset of adolescents will also report on fidelity of intervention delivery and linkage to&#xD;
      care (i.e., continued AOD discussion and/or treatment with a primary care provider) 1 month&#xD;
      after hospital discharge. In addition, nurses, social workers, and leaders from each&#xD;
      pediatric trauma center will report on organizational readiness for implementation at three&#xD;
      distinct time points. Results of this study will demonstrate that a highly scalable&#xD;
      implementation strategy, adapted for pediatric trauma centers from the results of our&#xD;
      mixed-methods implementation trial, will improve the fidelity (i.e., the consistency and&#xD;
      quality) of SBIRT delivery within pediatric trauma centers.&#xD;
&#xD;
      Primary Aim: Evaluate the effectiveness of the SSL implementation strategy in increasing&#xD;
      fidelity of SBIRT delivery at pediatric trauma centers, relative to usual implementation.&#xD;
&#xD;
      Hypothesis: Staff that receive the SSL will increase by 20% the proportion of admitted&#xD;
      injured adolescents receiving each element of the SBIRT protocol as indicated: a) validated&#xD;
      AOD screening, b) brief AOD intervention, and c) referral to appropriate care post-discharge&#xD;
      (i.e., continued AOD discussion/treatment with a health care provider).&#xD;
&#xD;
      Secondary Aim 1: Evaluate whether readiness for organizational change mediates the influence&#xD;
      of the SSL implementation strategy on implementation effectiveness (i.e., fidelity of SBIRT&#xD;
      delivery).&#xD;
&#xD;
      Hypothesis: The effect of the SSL on implementation effectiveness will be partially mediated&#xD;
      by organizational readiness to change.&#xD;
&#xD;
      Secondary Aim 2: Evaluate the effect of the SSL implementation strategy on improving patient&#xD;
      linkage to appropriate care (i.e., continued AOD discussion with primary care provider and/or&#xD;
      AOD treatment) following discharge from pediatric trauma centers.&#xD;
&#xD;
      Hypothesis: Injured adolescents that receive the SSL will report higher rates of AOD&#xD;
      discussion/treatment with a health care provider within 30 days of discharge, compared to&#xD;
      usual implementation.&#xD;
&#xD;
      Exploratory Aim: Examine the integration of counseling regarding the use of prescription pain&#xD;
      relievers into SBIRT delivery with injured adolescent patients who screen positive for AOD&#xD;
      use.&#xD;
&#xD;
      Hypothesis: Staff that receives the SSL will demonstrate higher rates of discussion of&#xD;
      appropriate pain medication use and medication disposal with patients who screen positive for&#xD;
      AOD use, compared to usual implementation.&#xD;
&#xD;
      The proposed research builds on our prior implementation research and has potential to impact&#xD;
      clinical care, address an important public health issue and significantly contribute to&#xD;
      implementation science.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Actual">March 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>This study utilizes a stepped wedge design.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will not know which arm their institution has been assigned to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of admitted injured adolescents receiving each element of the alcohol screening, brief intervention and referral to treatment (SBIRT) protocol</measure>
    <time_frame>54 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of readiness for organizational change within each institution</measure>
    <time_frame>9 months</time_frame>
    <description>Participating staff will complete organizational readiness for implementing change surveys throughout the study to identify if organizational readiness to change mediates implementation effectiveness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>30 days</time_frame>
    <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.)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of discussion of appropriate pain medication use and medication disposal with patients who screen positive for alcohol or other drug use.</measure>
    <time_frame>9 months</time_frame>
    <description>Rates will be determined through EMR review (rates of documented opioid counseling).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Alcohol Drinking</condition>
  <arm_group>
    <arm_group_label>SSL Implementation Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Science to Service Implementation Strategy for SBIRT adherence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard Care SBIRT services</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SSL Implementation Strategy</intervention_name>
    <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</description>
    <arm_group_label>SSL Implementation Strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Eligible adolescents must meet these criteria:&#xD;
&#xD;
        12-17 years of age Admitted to a participating trauma service for an injury Screened&#xD;
        positive for AOD use based on biologic testing or self-report on the alcohol screening tool&#xD;
        (S2BI) Fluent in English Able to provide written assent and parent able to provide written&#xD;
        consent.&#xD;
&#xD;
        Exclusion Criteria: Exclusion criteria include:&#xD;
&#xD;
        Prisoner or in police custody Admitted due to suicide attempt Any acute conditions that&#xD;
        would preclude provision of informed consent (i.e., acute psychosis, altered mental status,&#xD;
        cognitive impairment).&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Mello, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03297060/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03297060
org study id: 1R01AA025914
secondary id: 1R01AA025914
nct id: NCT03297060
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study utilizes a stepped wedge design.
primary purpose: Health Services Research
masking: Single (Participant)
masking description: Participants will not know which arm their institution has been assigned to.
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
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.
measure: Rate of readiness for organizational change within each institution
time frame: 9 months
description: Participating staff will complete organizational readiness for implementing change surveys throughout the study to identify if organizational readiness to change mediates implementation effectiveness
measure: 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
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.)
measure: 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
description: Rates will be determined through EMR review (rates of documented opioid counseling).
arm group label: SSL Implementation Strategy
arm group type: Experimental
description: Science to Service Implementation Strategy for SBIRT adherence
arm group label: Standard Care
arm group type: No Intervention
description: Standard Care SBIRT services
intervention type: Other
intervention name: SSL Implementation Strategy
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
arm group label: SSL Implementation Strategy
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Michael J Mello, MD, MPH
role: Principal Investigator
affiliation: Rhode Island Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcohol Drinking
provided document: 