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

NCT ID: NCT03042832

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Substance Use Disorder Mental Health Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Intention To Treat (ITT) model with clinics randomized to LOCI vs Webinar control
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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LOCI

Leadership development with coaching and organizational change support

Group Type EXPERIMENTAL

LOCI

Intervention Type BEHAVIORAL

Leadership development with coaching and organizational change support

Internet Based Training

Internet based Webinar leadership training

Group Type ACTIVE_COMPARATOR

Internet Based Webinar Leadership Training

Intervention Type BEHAVIORAL

Internet Based Webinar Leadership Training

Interventions

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LOCI

Leadership development with coaching and organizational change support

Intervention Type BEHAVIORAL

Internet Based Webinar Leadership Training

Internet Based Webinar Leadership Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Gregory Aarons

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UC San Diego

La Jolla, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28253900 (View on PubMed)

Aarons GA, Sklar M, Ehrhart MG, Roesch S, Moullin JC, Carandang K. Randomized trial of the leadership and organizational change for implementation (LOCI) strategy in substance use treatment clinics. J Subst Use Addict Treat. 2024 Oct;165:209437. doi: 10.1016/j.josat.2024.209437. Epub 2024 Jun 10.

Reference Type DERIVED
PMID: 38866139 (View on PubMed)

Other Identifiers

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141134

Identifier Type: -

Identifier Source: org_study_id

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