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Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention (LOCI)

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ClinicalTrials.gov Identifier: NCT03042832
Recruitment Status : Active, not recruiting
First Posted : February 3, 2017
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
San Diego State University
Information provided by (Responsible Party):
Gregory Aarons, University of California, San Diego

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:


Condition or disease Intervention/treatment Phase
Substance Use Disorder Mental Health Disorder Behavioral: LOCI Behavioral: WEBINAR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Health Services Research
Official Title: Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention in Substance Abuse Treatment Programs
Study Start Date : September 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: LOCI
Leadership development with coaching and organizational change support
Behavioral: LOCI
Leadership development with coaching and organizational change support

Active Comparator: WEBINAR
Webinar leadership training
Behavioral: WEBINAR
Webinar leadership training




Primary Outcome Measures :
  1. Implementation Leadership [ Time Frame: 12 months ]
    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.

  2. Full Range Leadership [ Time Frame: 12 months ]
    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 :
  1. Implementation Climate [ Time Frame: 12 months ]
    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.

  2. Attitudes Toward Evidence-Based Practice [ Time Frame: 12 months ]
    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.

  3. Implementation Citizenship Behavior [ Time Frame: 12 months ]
    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.

  4. Fidelity [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (webinars) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042832


Locations
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United States, California
UC San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
San Diego State University

Publications:
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Responsible Party: Gregory Aarons, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03042832     History of Changes
Other Study ID Numbers: 141134
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gregory Aarons, University of California, San Diego:
Leadership
Organizational Climate
Implementation
Implementation Climate
Motivational Interviewing
Fidelity

Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Mental Disorders
Pathologic Processes
Chemically-Induced Disorders