Substance Use DisorderLOCINCT03042832
Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention
A study testing LOCI and Internet Based Webinar Leadership Training in people with Substance Use Disorder and Mental Health Disorder, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorder, Mental Health Disorder
- What is being tested?
- LOCI and Internet Based Webinar Leadership Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2015to 31 May 2021
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention in Substance Abuse Treatment Programs
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:
Read the 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.
- Conditions
- Substance Use Disorder, Mental Health Disorder
- Being tested
- LOCI, Internet Based Webinar Leadership Training
- Keywords
- Leadership, Organizational Climate, Implementation, Implementation Climate, Motivational Interviewing, Fidelity
- Medical subject headings
- Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOCIBehavioural
Leadership development with coaching and organizational change support
Internet Based Webinar Leadership TrainingBehavioural
Internet Based Webinar Leadership Training
| Study group | Role | What they receive |
|---|---|---|
| LOCI | Experimental | Leadership development with coaching and organizational change support Receives: Behavioral: LOCI |
| Internet Based Training | Active comparator | Internet based Webinar leadership training Receives: Behavioral: Internet Based Webinar Leadership Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
Implementation Climate
- The Implementation Climate Scale (ICS; Ehrhart, Aarons, \& Farahnak, 2015) will be used to assess organizational climate for implementation. ICS dimensions include 1) focus on EBP, 2) educational support for EBP, 3) recognition for EBP, 4) rewards for EBP, 5) selection for EBP, and 6) selection for openness. Data will be aggregated at the workgroup level.
Measured: 12 months
Attitudes Toward Evidence-Based Practice
The Evidence-Based Practice Attitude Scale (EBPAS; Aarons 2004 will assess individuals attitudes toward EBP. The EBPAS is a 15-item measure with four subscales that assess attitudes toward adoption of EBP as a function of perceived appeal EBP, Requirements to use EBP, provider Openness, and perceived Divergence between EBP and usual care. The EBPAS is an individual level construct and will not be aggregated to the workgroup level.
Measured: 12 months
Implementation Citizenship Behavior
The Implementation Citizenship Behavior Scale (ICBS; Ehrhart, Aarons, Farahnak, 2015) [69] will be used to assess individuals EBP implementation citizenship behavior. The ICBS was adapted from an existing reliable and valid measure of safety citizenship behavior in the workplace [76] and assesses the extent to which individual workgroup members go above and beyond minimum requirements to support successful EBP implementation in regard to helping others and keeping informed. The ICBS is an individual level construct and will not be aggregated to the workgroup level.
Measured: 12 months
Fidelity
MI Coaching Rating Scale (MI-CRS; Naar-King \& Suarez, 2011) will be used. This scale was developed based on the Motivational Interviewing Treatment Integrity Instrument (MITI) [78] that has demonstrated inter-rater reliability and differentiates between MI and usual care. Data will be aggregated at the workgroup level.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start30 Sep 2015
- Primary completion20 Apr 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- Intention To Treat (ITT) model with clinics randomized to LOCI vs Webinar control
- Masking
- None (open label)
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Principal investigator, Gregory Aarons, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042832
- Sponsor's protocol ID
- 141134
- Acronym
- LOCI
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2016
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28253900Aarons 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.
PubMed 38866139
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention in Substance Abuse Treatment Programs
- ClinicalTrials.gov ID
- NCT03042832
- Acronym / sponsor ID
- LOCI / 141134
- Conditions
- Substance Use Disorder, Mental Health Disorder
- Keywords
- Leadership, Organizational Climate, Implementation, Implementation Climate, Motivational Interviewing, Fidelity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- San Diego State University
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intention To Treat (ITT) model with clinics randomized to LOCI vs Webinar control
| Arm | Type | Receives |
|---|---|---|
| LOCI | Experimental | Behavioral: LOCILeadership development with coaching and organizational change support |
| Internet Based Training | Active comparator | Behavioral: Internet Based Webinar Leadership TrainingInternet based Webinar leadership training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| LOCILeadership development with coaching and organizational change support | Behavioural | LOCI |
| Internet Based Webinar Leadership TrainingInternet Based Webinar Leadership Training | Behavioural | Internet Based Training |
Primary outcome
Implementation Leadership
Time frame: 12 months
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.
Full Range Leadership
Time frame: 12 months
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.
4 secondary outcomes
Implementation Climate
Time frame: 12 months
Attitudes Toward Evidence-Based Practice
Time frame: 12 months
Implementation Citizenship Behavior
Time frame: 12 months
Fidelity
Time frame: 12 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 11 Oct 2021.
- Background: PubMed 28253900Aarons 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.
- Derived from this study: PubMed 38866139Aarons 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.
- 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 LOCI and Internet Based Webinar Leadership Training in people with Substance Use Disorder and Mental Health Disorder, 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?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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 11 Oct 2021. 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?
Implementation Leadership (time frame: 12 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?
On the ClinicalTrials.gov record for NCT03042832, which also lists 2 linked publications.
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 11 Oct 2021.