NCT05344534

Brief Summary

This project will test an implementation strategy that seeks to align system, organization, and clinic leadership strategies to implement and sustain the Lyssn artificial intelligence (AI) quality assurance platform to support implementation of Motivational Interviewing (MI) and evidence-based practice (EBP) for substance use disorders. The Leadership and Organizational Change for Implementation - System Level (LOCI-SL) strategy seeks to engage policymakers and funders at the system level to improve implementation leadership, climate, provider attitudes and behaviors at the provider organization level to enhance implementation climate for EBP. LOCI-SL will be tested in a statewide addiction service system through clinics in community based behavioral health organizations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
479

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

April 18, 2022

Last Update Submit

January 13, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change on Implementation Leadership Scale

    Assesses four dimensions of implementation leadership: knowledge, proactive, perseverent, supportive, scale of 0-4 where higher scores are more positive

    Change from Baseline through study completion, an average of 9 months

  • Change on Implementation Climate Scale

    6 dimensions of implementation climate: focus, education, recruitment, selection, recognition, rewards scale of 0-4 where higher scores are more positive

    Change from Baseline through study completion, an average of 9 months

Secondary Outcomes (2)

  • Change on Evidence-based Practice Attitudes Scale

    Change from Baseline through study completion, an average of 9 months

  • Change on Implementation Citizenship Behavior Scale

    Change from Baseline through study completion, an average of 9 months

Study Arms (2)

Control

NO INTERVENTION

assessment only through online survey

LOCI

EXPERIMENTAL

Leadership and Organizational Change for Implementation strategy

Behavioral: Leadership and Organizational Change for Implementation

Interventions

LOCI is data driven leadership development and coaching for clinic managers and working with agency executives and middle managers to foster a strategic implementation climate

LOCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
1. Stakeholders from Oregon Health Authority (OHA), Oregon Alcohol and Drug Policy Commission (ADPC), staff at provider/payer advocacy organizations (e.g., CCO Oregon, Oregon Council for Behavioral Health), and relevant managed care organizations (Coordinated Care Organizations, CCOs), Indiana Department of Mental Health and Addiction (DMHA), or Indiana Department of Child Services (DCS). 2. Executives and/or managers at participating substance use disorder and/or mental health treatment agencies. 3. Clinic managers/supervisors in clinics that provide substance use disorder and/or mental health treatment. 4. Counselors (i.e., service providers) employed at participating agencies that provide substance use disorder and/or mental health treatment.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Interventions

LeadershipOrganizational Innovation

Intervention Hierarchy (Ancestors)

Personnel ManagementOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Stepped-wedge
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 25, 2022

Study Start

August 30, 2021

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations