NCT03042832

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:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

4.6 years

First QC Date

October 25, 2016

Last Update Submit

October 4, 2021

Conditions

Substance Use DisorderMental Health Disorder

Keywords

LeadershipOrganizational ClimateImplementationImplementation ClimateMotivational InterviewingFidelity

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 months

  • 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.

    12 months

Secondary Outcomes (4)

  • Implementation Climate

    12 months

  • Attitudes Toward Evidence-Based Practice

    12 months

  • Implementation Citizenship Behavior

    12 months

  • Fidelity

    12 months

Study Arms (2)

LOCI

EXPERIMENTAL

Leadership development with coaching and organizational change support

Behavioral: LOCI

Internet Based Training

ACTIVE COMPARATOR

Internet based Webinar leadership training

Behavioral: Internet Based Webinar Leadership Training

Interventions

LOCIBEHAVIORAL

Leadership development with coaching and organizational change support

LOCI
Internet Based Webinar Leadership TrainingBEHAVIORAL

Internet Based Webinar Leadership Training

Internet Based Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

Related Publications (2)

  • 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: 28253900BACKGROUND

  • 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.

    PMID: 38866139DERIVED

MeSH Terms

Conditions

Substance-Related DisordersMental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: Intention To Treat (ITT) model with clinics randomized to LOCI vs Webinar control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 25, 2016

First Posted

February 3, 2017

Study Start

September 30, 2015

Primary Completion

April 20, 2020

Study Completion

May 31, 2021

Last Updated

October 11, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)