Clinical trial NCT03042832: Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention
Official title: Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention in Substance Abuse Treatment Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Mental Health Disorder
Keywords: Leadership
Organizational Climate
Implementation
Implementation Climate
Motivational Interviewing
Fidelity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2017-02-03
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Intention To Treat (ITT) model with clinics randomized to LOCI vs Webinar control
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Implementation Leadership
timeFrame: 12 months
measure: Full Range Leadership
timeFrame: 12 months
Secondary outcomes:
measure: Implementation Climate
timeFrame: 12 months
measure: Attitudes Toward Evidence-Based Practice
timeFrame: 12 months
measure: Implementation Citizenship Behavior
timeFrame: 12 months
measure: Fidelity
timeFrame: 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
References:
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.