NCT07053098

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress52%
Mar 2025May 2027

Study Start

First participant enrolled

March 18, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

June 30, 2025

Last Update Submit

June 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prescribing medications for alcohol use disorder

    Change in the proportion of eligible patients prescribed a medication for alcohol use disorder in the clinic

    6 months after the end of implementation facilitation

Study Arms (1)

Implementation Facilitation

EXPERIMENTAL

This Implementation Facilitation Intervention will include external facilitation, staff training, patient education, audit and feedback, and care coordination.

Other: Implementation Facilitation

Interventions

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.

Implementation Facilitation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • For all: age is less than 18 years old
  • For all: not able to complete informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Alcohol-Related DisordersMental Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced Disorders

Study Officials

  • Melanie Bennett

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 8, 2025

Study Start

March 18, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

July 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations