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OpenTrials
Completed

NCT Number: NCT05344534

Statewide System and Organizational Strategy for EBP Implementation

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92093, United States

About this study

The NIH has called for testing promising implementation strategies (PAR-19-274) and there is a critical need for implementation and sustainment of effective and evidence-based practices (EBPs) to address health conditions including substance use disorders (SUDs) which are among the most complex of public health issues. The proposed project is consistent with NIDA's Priority Focus Area "Strategies to improve the effective and sustainable implementation of evidence-based prevention and treatment interventions (implementation science)." Most implementation strategies do not address the complex multilevel context for implementation in public service sectors, but rather focus on direct service providers. This proposed project will expand the Leadership and Organizational Change for Implementation (LOCI) organizational change strategy for EBP implementation and sustainment, to address the larger outer system context in which SUD treatment organizations operate through engaging state policy and funding stakeholders along with community-based behavioral health agencies to understand and work toward aligning state-level policies and with organizational implementation improvement strategies. The project will focus on implementation and sustainment of the Lyssn artificial intelligence (AI) quality assurance platform along with implementation of Motivational Interviewing (MI). Consistent with the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and system and organizational theory, the investigators will add a system level component to LOCI with the goal of bridging outer and inner context and developing and aligning a positive implementation climate to support implementation and sustainment of Lyssn and MI in SUD treatment agencies. The study will use mixed qualitative and quantitative methods in a stepped-wedge design to examine change in implementation leadership and implementation climate as a function the LOCI-SL intervention as well as exploring subsequent Lyssn and MI sustainment. The study will also include a "scaling-out" aim in which data from this study will be used to compare proposed mediational pathways (i.e., mechanisms) with data from a prior study. The study will involve ongoing engagement with state policy and funding stakeholders and qualitative examination of ways to facilitate academic-policy collaborations to enhance EBP implementation and sustainment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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).
  • Executives and/or managers at participating substance use disorder and/or mental health treatment agencies.
  • Clinic managers/supervisors in clinics that provide substance use disorder and/or mental health treatment.
  • Counselors (i.e., service providers) employed at participating agencies that provide substance use disorder and/or mental health treatment.

Treatment and study plan

Leadership and organizational change for implementation

Behavioral

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

Primary outcomes

  1. Change on Implementation Leadership Scale

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

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

  2. Change on Implementation Climate Scale

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

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

Secondary outcomes

  1. Change on Evidence-based Practice Attitudes Scale

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

    assess individual attitudes toward evidence-based practices scale of 0-4 where higher scores are more positive

  2. Change on Implementation Citizenship Behavior Scale

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

    assesses degree to which provider behaviors support EBP implementation, scale of 0-4 where higher scores are more positive

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Chestnut Health Systems
  • Pacific Institute for Research and Evaluation
  • University of Central Florida

Registry information

Official study title

Statewide System and Organizational Strategy for Evidence-Based Practice Implementation and Sustainment in Substance Use Disorder Treatment

Acronym: LOCI-SL

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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