Alcohol-Related DisordersNCT07053098
External Facilitation to Increase Prescribing of AUD Medications in the Psychiatric Setting
A study testing Implementation Facilitation in people with Alcohol-Related Disorders and Psychiatric Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This project will pilot test an implementation facilitation intervention to increase prescribing of medications for alcohol use disorder (MAUD) in patients with major mental illness and alcohol use disorder in three psychiatry treatment clinics. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Alcohol-Related Disorders, Psychiatric Disorder
- What is being tested?
- Implementation Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For prescribers: working as a prescriber, non-prescribing clinician, or administrator at one of the three participating clinics.
- For patients: has major mental illness (major depressive disorders, bipolar disorder, schizophrenia spectrum disorders, other psychotic disorders; posttraumatic stress disorder)
- For patients: has Alcohol Use Disorder and is being treated in one of the three participating clinics.
Who cannot join
- For all: age is less than 18 years old
- For all: not able to complete informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Baltimore
Baltimore, Maryland, 21201
Melanie Bennett, 410-706-0892, mbennett@som.umaryland.edu
Brian Brandler, bbrandler@som.umaryland.edu
About this study
This project will pilot test an implementation facilitation intervention to increase prescribing of medications for alcohol use disorder (MAUD) in patients with major mental illness and alcohol use disorder in three psychiatry treatment clinics.
Read the detailed description
This project will pilot test an implementation facilitation intervention to increase prescribing of medications for alcohol use disorder (MAUD) in patients with major mental illness and alcohol use disorder in three psychiatry treatment clinics. Guided by the integrated Promoting Action on Research Implementation in Health Services framework, an external facilitator will work with each clinics' internal champion to (1) provide clinic level education on MAUD in non-specialty care settings, (2) provide clinic level training in using a standardized screen measure for alcohol use disorder, documenting screening results in the electronic health record, and documenting alcohol use disorder diagnosis in the electronic health record, (3) help internal champions use an audit and feedback system for weekly review of MAUD education and prescribing, (4) help internal champions do weekly care coordination for patients with major mental illness and alcohol use disorder, and (5) make educational materials on MAUD available on site to patients so they are informed about these treatment options. Internal champions and clinics will have access to consultation from a MAUD clinician expert. These activities will take place across pre-implementation and implementation phases and will be followed by a post-implementation facilitation sustainment period during which clinics and champions continue implementation on their own. Formative Evaluation activities will take place throughout; at the end of the sustainment phase, MAUD outcomes will be assessed.
- Conditions
- Alcohol-Related Disorders, Psychiatric Disorder
- Being tested
- Implementation Facilitation
- Medical subject headings
- Alcohol-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation FacilitationOther
Implementation facilitation is a multi-faceted process of enabling and supporting the adoption and integration of best practices into routine clinical care. It involves collaboration to understand a setting's challenges and barriers and working together to identify the best activities to address them. IF will incorporate External Facilitation, a problem-solving implementation strategy that builds supportive interpersonal relationships between an External Facilitator who is outside of the clinic who works with clinics and their identified internal champions to learn their unique barriers to implementation, use strategies to address these barriers, and plan for sustainability by integrating the practice into routine processes and workflows. Other implementation activities that will be used IF include staff training, patient education, audit and feedback, and care coordination.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Facilitation | Experimental | This Implementation Facilitation Intervention will include external facilitation, staff training, patient education, audit and feedback, and care coordination. Receives: Other: Implementation Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescribing medications for alcohol use disorder
Change in the proportion of eligible patients prescribed a medication for alcohol use disorder in the clinic
Measured: 6 months after the end of implementation facilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start18 Mar 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie E Bennett, University of Maryland, Baltimore
- Investigators
- Melanie Bennett, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053098
- Sponsor's protocol ID
- 1R34AA032051-01
- Status last verified
- May 2026
- First submitted
- 30 Jun 2025
- Last updated
- 3 Jun 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Facilitation to Increase Prescribing of AUD Medications in the Psychiatric Setting
- ClinicalTrials.gov ID
- NCT07053098
- Acronym / sponsor ID
- 1R34AA032051-01
- Conditions
- Alcohol-Related Disorders, Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 Jul 2025 (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 pilot test an implementation facilitation intervention to increase prescribing of medications for alcohol use disorder (MAUD) in patients with major mental illness and alcohol use disorder in three psychiatry treatment clinics.
Detailed description
This project will pilot test an implementation facilitation intervention to increase prescribing of medications for alcohol use disorder (MAUD) in patients with major mental illness and alcohol use disorder in three psychiatry treatment clinics. Guided by the integrated Promoting Action on Research Implementation in Health Services framework, an external facilitator will work with each clinics' internal champion to (1) provide clinic level education on MAUD in non-specialty care settings, (2) provide clinic level training in using a standardized screen measure for alcohol use disorder, documenting screening results in the electronic health record, and documenting alcohol use disorder diagnosis in the electronic health record, (3) help internal champions use an audit and feedback system for weekly review of MAUD education and prescribing, (4) help internal champions do weekly care coordination for patients with major mental illness and alcohol use disorder, and (5) make educational materials on MAUD available on site to patients so they are informed about these treatment options. Internal champions and clinics will have access to consultation from a MAUD clinician expert. These activities will take place across pre-implementation and implementation phases and will be followed by a post-implementation facilitation sustainment period during which clinics and champions continue implementation on their own. Formative Evaluation activities will take place throughout; at the end of the sustainment phase, MAUD outcomes will be assessed.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation Facilitation | Experimental | Other: Implementation FacilitationThis Implementation Facilitation Intervention will include external facilitation, staff training, patient education, audit and feedback, and care coordination. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- For prescribers: working as a prescriber, non-prescribing clinician, or administrator at one of the three participating clinics.
- For patients: has major mental illness (major depressive disorders, bipolar disorder, schizophrenia spectrum disorders, other psychotic disorders; posttraumatic stress disorder)
- For patients: has Alcohol Use Disorder and is being treated in one of the three participating clinics.
Key exclusion criteria (2 listed)
- For all: age is less than 18 years old
- For all: not able to complete informed consent
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 |
|---|---|---|
| Implementation FacilitationImplementation facilitation is a multi-faceted process of enabling and supporting the adoption and integration of best practices into routine clinical care. It involves collaboration to understand a setting's challenges and barriers and working together to identify the best activities to address them. IF will incorporate External Facilitation, a problem-solving implementation strategy that builds supportive interpersonal relationships between an External Facilitator who is outside of the clinic who works with clinics and their identified internal champions to learn their unique barriers to implementation, use strategies to address these barriers, and plan for sustainability by integrating the practice into routine processes and workflows. Other implementation activities that will be used IF include staff training, patient education, audit and feedback, and care coordination. | Other | Implementation Facilitation |
Primary outcome
Prescribing medications for alcohol use disorder
Time frame: 6 months after the end of implementation facilitation
Change in the proportion of eligible patients prescribed a medication for alcohol use disorder in the clinic
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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.
Melanie Bennett principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Facilitation in people with Alcohol-Related Disorders and Psychiatric Disorder, run by University of Maryland, Baltimore 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 3 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: looking for participants now, as of the sponsor's last update on 3 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Bennett, PhD (410-706-2490, mbennett@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescribing medications for alcohol use disorder (time frame: 6 months after the end of implementation facilitation). 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 3 Jun 2026.