Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention (LOCI)
Primary Purpose
Substance Use Disorder, Mental Health Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LOCI
Internet Based Webinar Leadership Training
Sponsored by
About this trial
This is an interventional health services research trial for Substance Use Disorder focused on measuring Leadership, Organizational Climate, Implementation, Implementation Climate, Motivational Interviewing, Fidelity
Eligibility Criteria
Inclusion Criteria:
- Substance use disorder treatment service providers, supervisors, agency executives/managers
- Supervisors will be the only individuals eligible to participate in the experimental (LOCI) or control condition (internet based) leadership intervention.
- Only supervisors in the experimental (LOCI) condition will be eligible to participate in focus groups.
- Only agency executives/managers participating in the organizational strategy development meetings of the LOCI intervention condition will be eligible to participate in interviews.
Exclusion Criteria:
- Personnel not providing or supervising direct services (e.g., administrative staff) are not included as most of the measures will not be applicable to these staff.
- Participants must be at least 18 years of age and employed at one of the participating agencies.
Sites / Locations
- UC San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LOCI
Internet Based Training
Arm Description
Leadership development with coaching and organizational change support
Internet based Webinar leadership training
Outcomes
Primary Outcome Measures
Implementation Leadership
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.
Full Range Leadership
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.
Secondary Outcome Measures
Implementation Climate
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.
Attitudes Toward Evidence-Based Practice
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.
Implementation Citizenship Behavior
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.
Fidelity
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.
Full Information
NCT ID
NCT03042832
First Posted
October 25, 2016
Last Updated
October 4, 2021
Sponsor
University of California, San Diego
Collaborators
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT03042832
Brief Title
Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention
Acronym
LOCI
Official Title
Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention in Substance Abuse Treatment Programs
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2015 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
San Diego State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder, Mental Health Disorder
Keywords
Leadership, Organizational Climate, Implementation, Implementation Climate, Motivational Interviewing, Fidelity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Intention To Treat (ITT) model with clinics randomized to LOCI vs Webinar control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
448 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LOCI
Arm Type
Experimental
Arm Description
Leadership development with coaching and organizational change support
Arm Title
Internet Based Training
Arm Type
Active Comparator
Arm Description
Internet based Webinar leadership training
Intervention Type
Behavioral
Intervention Name(s)
LOCI
Intervention Description
Leadership development with coaching and organizational change support
Intervention Type
Behavioral
Intervention Name(s)
Internet Based Webinar Leadership Training
Intervention Description
Internet Based Webinar Leadership Training
Primary Outcome Measure Information:
Title
Implementation Leadership
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.
Time Frame
12 months
Title
Full Range Leadership
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Implementation Climate
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.
Time Frame
12 months
Title
Attitudes Toward Evidence-Based Practice
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.
Time Frame
12 months
Title
Implementation Citizenship Behavior
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.
Time Frame
12 months
Title
Fidelity
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Substance use disorder treatment service providers, supervisors, agency executives/managers
Supervisors will be the only individuals eligible to participate in the experimental (LOCI) or control condition (internet based) leadership intervention.
Only supervisors in the experimental (LOCI) condition will be eligible to participate in focus groups.
Only agency executives/managers participating in the organizational strategy development meetings of the LOCI intervention condition will be eligible to participate in interviews.
Exclusion Criteria:
Personnel not providing or supervising direct services (e.g., administrative staff) are not included as most of the measures will not be applicable to these staff.
Participants must be at least 18 years of age and employed at one of the participating agencies.
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28253900
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.
Results Reference
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Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention
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