ControlLOCI-SLNCT05344534
Statewide System and Organizational Strategy for EBP Implementation
A study testing Leadership and Organizational Change for Implementation in people with Control and Experimental, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Control, Experimental
- What is being tested?
- Leadership and Organizational Change for Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Statewide System and Organizational Strategy for Evidence-Based Practice Implementation and Sustainment in Substance Use Disorder Treatment
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.
Read the detailed description
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.
- Conditions
- Control, Experimental
- Being tested
- Leadership and Organizational Change for Implementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadership and Organizational Change for ImplementationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | assessment only through online survey |
| LOCI | Experimental | Leadership and Organizational Change for Implementation strategy Receives: Behavioral: Leadership and Organizational Change for Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from Baseline through study completion, an average of 9 months
Secondary outcomes (2)
Change on Evidence-based Practice Attitudes Scale
assess individual attitudes toward evidence-based practices scale of 0-4 where higher scores are more positive
Measured: Change from Baseline through study completion, an average of 9 months
Change on Implementation Citizenship Behavior Scale
assesses degree to which provider behaviors support EBP implementation, scale of 0-4 where higher scores are more positive
Measured: Change from Baseline through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start30 Aug 2021
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge
- Masking
- None (open label)
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Florida, Pacific Institute for Research and Evaluation, Chestnut Health Systems
- Responsible party
- Principal investigator, Gregory Aarons, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344534
- Sponsor's protocol ID
- 200855
- Acronym
- LOCI-SL
- Status last verified
- Jan 2026
- First submitted
- 18 Apr 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statewide System and Organizational Strategy for Evidence-Based Practice Implementation and Sustainment in Substance Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT05344534
- Acronym / sponsor ID
- LOCI-SL / 200855
- Conditions
- Control, Experimental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Central Florida, Pacific Institute for Research and Evaluation, Chestnut Health Systems
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –assessment only through online survey |
| LOCI | Experimental | Behavioral: Leadership and Organizational Change for ImplementationLeadership and Organizational Change for Implementation strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leadership and Organizational Change for ImplementationLOCI is data driven leadership development and coaching for clinic managers and working with agency executives and middle managers to foster a strategic implementation climate | Behavioural | LOCI |
Primary outcome
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
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
2 secondary outcomes
Change on Evidence-based Practice Attitudes Scale
Time frame: Change from Baseline through study completion, an average of 9 months
Change on Implementation Citizenship Behavior Scale
Time frame: Change from Baseline through study completion, an average of 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leadership and Organizational Change for Implementation in people with Control and Experimental, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Implementation Leadership Scale (time frame: Change from Baseline through study completion, an average of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.