<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/NCT03042832</url>
  </required_header>
  <id_info>
    <org_study_id>141134</org_study_id>
    <nct_id>NCT03042832</nct_id>
  </id_info>
  <brief_title>Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention</brief_title>
  <acronym>LOCI</acronym>
  <official_title>Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention in Substance Abuse Treatment Programs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test the effects of the Leadership and Organizational Change for&#xD;
      Implementation (LOCI) intervention in facilitating evidence-based practice (EBP)&#xD;
      implementation in substance use disorder (SUD) and HIV services settings. LOCI improves&#xD;
      implementation leadership and organizational support to develop strategic climate for EBP&#xD;
      implementation. Greater efficiency and effectiveness of EBP implementation will improve the&#xD;
      public health impact of evidence-based health and allied healthcare innovations and lead to&#xD;
      greater effectiveness of SUD and HIV services.&#xD;
&#xD;
      Project Terms:&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effective implementation of evidence-based practices (EBPs) to address complex and widespread&#xD;
      public health issues, such as substance use disorders (SUDs) and HIV, remains a substantial&#xD;
      challenge. Leadership and organizational context are associated with implementation climate&#xD;
      and attitudes toward EBP, as well as clinical outcomes such as client satisfaction and&#xD;
      quality of life. While there are many leadership development approaches, they are often not&#xD;
      based on empirically supported approaches and curricula, nor are they specifically designed&#xD;
      to develop strategic climates for EBP implementation. This project addresses these concerns&#xD;
      and advances implementation science by testing the effects of the Leadership and&#xD;
      Organizational Change for Implementation (LOCI) intervention. The goals of the LOCI&#xD;
      intervention are to improve general leadership and implementation leadership and utilize&#xD;
      organizational strategies to create a positive strategic organizational climate for EBP&#xD;
      implementation. These should lead to more positive SUD treatment provider attitudes and&#xD;
      behaviors that support EBP implementation outcomes of intervention fidelity and&#xD;
      implementation process. Consistent with the Exploration, Preparation, Implementation,&#xD;
      Sustainment (EPIS) conceptual framework, LOCI creates change at multiple levels within a&#xD;
      provider organization (e.g., executives/mid- managers, workgroup leader, service provider) to&#xD;
      foster a context supportive of EBP implementation and sustainment. Initial support for the&#xD;
      feasibility, acceptability, and utility of the LOCI intervention have been successfully&#xD;
      demonstrated in an NIH supported pilot study (R21MH082731, PI: Aarons). The proposed study&#xD;
      will test whether LOCI can achieve change in outcomes of general and implementation&#xD;
      leadership, implementation climate, implementation process, and EBP fidelity in SUD treatment&#xD;
      agencies. Seventy-two workgroup leaders and their providers (i.e., subordinates) will be&#xD;
      randomized to either the LOCI condition or a Webinar control condition. All direct SUD&#xD;
      treatment providers in both conditions will receive training in Motivational Interviewing&#xD;
      (MI), a leading EBP for SUD and HIV prevention and treatment. The test of LOCI will occur&#xD;
      within four agencies that provide SUD treatment at multiple sites across California. The test&#xD;
      of the LOCI intervention will include SUD service providers (n=320), workgroup leaders&#xD;
      (n=60), and agency executives/mid-managers (n=16). Hypotheses will be tested comparing LOCI&#xD;
      and control group outcomes of leadership, implementation climate, psychological safety&#xD;
      climate, provider attitudes and behaviors, MI fidelity, and implementation process. The&#xD;
      proposed study will provide a practical implementation strategy that can be utilized to&#xD;
      improve workgroup leadership and strategic climate for EBP implementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2015</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Intention To Treat (ITT) model with clinics randomized to LOCI vs Webinar control</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implementation Leadership</measure>
    <time_frame>12 months</time_frame>
    <description>The Implementation Leadership Scale (ILS: Aarons et al., 2014) is a brief 12-item measure with four subscales: Proactive Leadership, Knowledgeable Leadership, Supportive Leadership, and Perseverant Leadership. This measure will be included in the survey for providers, workgroup supervisors, and managers/executives. Data will be aggregated at the workgroup level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Full Range Leadership</measure>
    <time_frame>12 months</time_frame>
    <description>The Multifactor Leadership Questionnaire (MLQ: Bass &amp; Avolio, 1990) is one of the most widely used measures of leadership in organizations. The MLQ assesses transformational and transactional leadership. This measure will be included in the survey for providers, workgroup supervisors, and managers/executives.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implementation Climate</measure>
    <time_frame>12 months</time_frame>
    <description>1. The Implementation Climate Scale (ICS; Ehrhart, Aarons, &amp; Farahnak, 2015) will be used to assess organizational climate for implementation. ICS dimensions include 1) focus on EBP, 2) educational support for EBP, 3) recognition for EBP, 4) rewards for EBP, 5) selection for EBP, and 6) selection for openness. Data will be aggregated at the workgroup level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes Toward Evidence-Based Practice</measure>
    <time_frame>12 months</time_frame>
    <description>The Evidence-Based Practice Attitude Scale (EBPAS; Aarons 2004 will assess individuals attitudes toward EBP. The EBPAS is a 15-item measure with four subscales that assess attitudes toward adoption of EBP as a function of perceived appeal EBP, Requirements to use EBP, provider Openness, and perceived Divergence between EBP and usual care. The EBPAS is an individual level construct and will not be aggregated to the workgroup level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation Citizenship Behavior</measure>
    <time_frame>12 months</time_frame>
    <description>The Implementation Citizenship Behavior Scale (ICBS; Ehrhart, Aarons, Farahnak, 2015) [69] will be used to assess individuals EBP implementation citizenship behavior. The ICBS was adapted from an existing reliable and valid measure of safety citizenship behavior in the workplace [76] and assesses the extent to which individual workgroup members go above and beyond minimum requirements to support successful EBP implementation in regard to helping others and keeping informed. The ICBS is an individual level construct and will not be aggregated to the workgroup level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fidelity</measure>
    <time_frame>12 months</time_frame>
    <description>MI Coaching Rating Scale (MI-CRS; Naar-King &amp; Suarez, 2011) will be used. This scale was developed based on the Motivational Interviewing Treatment Integrity Instrument (MITI) [78] that has demonstrated inter-rater reliability and differentiates between MI and usual care. Data will be aggregated at the workgroup level.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">448</enrollment>
  <condition>Substance Use Disorder</condition>
  <condition>Mental Health Disorder</condition>
  <arm_group>
    <arm_group_label>LOCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Leadership development with coaching and organizational change support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Internet Based Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Internet based Webinar leadership training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LOCI</intervention_name>
    <description>Leadership development with coaching and organizational change support</description>
    <arm_group_label>LOCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet Based Webinar Leadership Training</intervention_name>
    <description>Internet Based Webinar Leadership Training</description>
    <arm_group_label>Internet Based Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Substance use disorder treatment service providers, supervisors, agency&#xD;
             executives/managers&#xD;
&#xD;
          -  Supervisors will be the only individuals eligible to participate in the experimental&#xD;
             (LOCI) or control condition (internet based) leadership intervention.&#xD;
&#xD;
          -  Only supervisors in the experimental (LOCI) condition will be eligible to participate&#xD;
             in focus groups.&#xD;
&#xD;
          -  Only agency executives/managers participating in the organizational strategy&#xD;
             development meetings of the LOCI intervention condition will be eligible to&#xD;
             participate in interviews.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personnel not providing or supervising direct services (e.g., administrative staff)&#xD;
             are not included as most of the measures will not be applicable to these staff.&#xD;
&#xD;
          -  Participants must be at least 18 years of age and employed at one of the participating&#xD;
             agencies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Aarons GA, Ehrhart MG, Moullin JC, Torres EM, Green AE. Testing the leadership and organizational change for implementation (LOCI) intervention in substance abuse treatment: a cluster randomized trial study protocol. Implement Sci. 2017 Mar 3;12(1):29. doi: 10.1186/s13012-017-0562-3.</citation>
    <PMID>28253900</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Gregory Aarons</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Leadership</keyword>
  <keyword>Organizational Climate</keyword>
  <keyword>Implementation</keyword>
  <keyword>Implementation Climate</keyword>
  <keyword>Motivational Interviewing</keyword>
  <keyword>Fidelity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03042832
org study id: 141134
nct id: NCT03042832
lead sponsor: 
collaborator: 
has dmc: No
This study will test the effects of the Leadership and Organizational Change for
      Implementation (LOCI) intervention in facilitating evidence-based practice (EBP)
      implementation in substance use disorder (SUD) and HIV services settings. LOCI improves
      implementation leadership and organizational support to develop strategic climate for EBP
      implementation. Greater efficiency and effectiveness of EBP implementation will improve the
      public health impact of evidence-based health and allied healthcare innovations and lead to
      greater effectiveness of SUD and HIV services.

      Project Terms:
Effective implementation of evidence-based practices (EBPs) to address complex and widespread
      public health issues, such as substance use disorders (SUDs) and HIV, remains a substantial
      challenge. Leadership and organizational context are associated with implementation climate
      and attitudes toward EBP, as well as clinical outcomes such as client satisfaction and
      quality of life. While there are many leadership development approaches, they are often not
      based on empirically supported approaches and curricula, nor are they specifically designed
      to develop strategic climates for EBP implementation. This project addresses these concerns
      and advances implementation science by testing the effects of the Leadership and
      Organizational Change for Implementation (LOCI) intervention. The goals of the LOCI
      intervention are to improve general leadership and implementation leadership and utilize
      organizational strategies to create a positive strategic organizational climate for EBP
      implementation. These should lead to more positive SUD treatment provider attitudes and
      behaviors that support EBP implementation outcomes of intervention fidelity and
      implementation process. Consistent with the Exploration, Preparation, Implementation,
      Sustainment (EPIS) conceptual framework, LOCI creates change at multiple levels within a
      provider organization (e.g., executives/mid- managers, workgroup leader, service provider) to
      foster a context supportive of EBP implementation and sustainment. Initial support for the
      feasibility, acceptability, and utility of the LOCI intervention have been successfully
      demonstrated in an NIH supported pilot study (R21MH082731, PI: Aarons). The proposed study
      will test whether LOCI can achieve change in outcomes of general and implementation
      leadership, implementation climate, implementation process, and EBP fidelity in SUD treatment
      agencies. Seventy-two workgroup leaders and their providers (i.e., subordinates) will be
      randomized to either the LOCI condition or a Webinar control condition. All direct SUD
      treatment providers in both conditions will receive training in Motivational Interviewing
      (MI), a leading EBP for SUD and HIV prevention and treatment. The test of LOCI will occur
      within four agencies that provide SUD treatment at multiple sites across California. The test
      of the LOCI intervention will include SUD service providers (n=320), workgroup leaders
      (n=60), and agency executives/mid-managers (n=16). Hypotheses will be tested comparing LOCI
      and control group outcomes of leadership, implementation climate, psychological safety
      climate, provider attitudes and behaviors, MI fidelity, and implementation process. The
      proposed study will provide a practical implementation strategy that can be utilized to
      improve workgroup leadership and strategic climate for EBP implementation.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Intention To Treat (ITT) model with clinics randomized to LOCI vs Webinar control
primary purpose: Health Services Research
masking: None (Open Label)
measure: Implementation Leadership
time frame: 12 months
description: The Implementation Leadership Scale (ILS: Aarons et al., 2014) is a brief 12-item measure with four subscales: Proactive Leadership, Knowledgeable Leadership, Supportive Leadership, and Perseverant Leadership. This measure will be included in the survey for providers, workgroup supervisors, and managers/executives. Data will be aggregated at the workgroup level.
measure: Full Range Leadership
time frame: 12 months
description: The Multifactor Leadership Questionnaire (MLQ: Bass & Avolio, 1990) is one of the most widely used measures of leadership in organizations. The MLQ assesses transformational and transactional leadership. This measure will be included in the survey for providers, workgroup supervisors, and managers/executives.
measure: Implementation Climate
time frame: 12 months
description: 1. The Implementation Climate Scale (ICS; Ehrhart, Aarons, & Farahnak, 2015) will be used to assess organizational climate for implementation. ICS dimensions include 1) focus on EBP, 2) educational support for EBP, 3) recognition for EBP, 4) rewards for EBP, 5) selection for EBP, and 6) selection for openness. Data will be aggregated at the workgroup level.
measure: Attitudes Toward Evidence-Based Practice
time frame: 12 months
description: The Evidence-Based Practice Attitude Scale (EBPAS; Aarons 2004 will assess individuals attitudes toward EBP. The EBPAS is a 15-item measure with four subscales that assess attitudes toward adoption of EBP as a function of perceived appeal EBP, Requirements to use EBP, provider Openness, and perceived Divergence between EBP and usual care. The EBPAS is an individual level construct and will not be aggregated to the workgroup level.
measure: Implementation Citizenship Behavior
time frame: 12 months
description: The Implementation Citizenship Behavior Scale (ICBS; Ehrhart, Aarons, Farahnak, 2015) [69] will be used to assess individuals EBP implementation citizenship behavior. The ICBS was adapted from an existing reliable and valid measure of safety citizenship behavior in the workplace [76] and assesses the extent to which individual workgroup members go above and beyond minimum requirements to support successful EBP implementation in regard to helping others and keeping informed. The ICBS is an individual level construct and will not be aggregated to the workgroup level.
measure: Fidelity
time frame: 12 months
description: MI Coaching Rating Scale (MI-CRS; Naar-King & Suarez, 2011) will be used. This scale was developed based on the Motivational Interviewing Treatment Integrity Instrument (MITI) [78] that has demonstrated inter-rater reliability and differentiates between MI and usual care. Data will be aggregated at the workgroup level.
arm group label: LOCI
arm group type: Experimental
description: Leadership development with coaching and organizational change support
arm group label: Internet Based Training
arm group type: Active Comparator
description: Internet based Webinar leadership training
intervention type: Behavioral
intervention name: LOCI
description: Leadership development with coaching and organizational change support
arm group label: LOCI
intervention type: Behavioral
intervention name: Internet Based Webinar Leadership Training
description: Internet Based Webinar Leadership Training
arm group label: Internet Based Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Aarons GA, Ehrhart MG, Moullin JC, Torres EM, Green AE. Testing the leadership and organizational change for implementation (LOCI) intervention in substance abuse treatment: a cluster randomized trial study protocol. Implement Sci. 2017 Mar 3;12(1):29. doi: 10.1186/s13012-017-0562-3.
PMID: 28253900
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Gregory Aarons
investigator title: Professor
mesh term: Substance-Related Disorders
mesh term: Mental Disorders
sharing ipd: No