NCT04303676

Brief Summary

Alcohol use is the third leading cause of death in the United States. Primary care practices need to implement new research findings that help identify and treat alcohol use disorder. This project will compare two methods of supporting small and medium size primary care practices in Colorado and surrounding states to improve their alcohol screening and treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
399

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

2.7 years

First QC Date

March 2, 2020

Last Update Submit

December 15, 2023

Conditions

Keywords

Primary Health CareAlcohol DrinkingQuality Improvement

Outcome Measures

Primary Outcomes (6)

  • Change from baseline in the proportion of eligible patients screened for unhealthy alcohol use

    Change from baseline in number and percent of eligible patients (18 years old or older) screened for unhealthy alcohol use. Change will be assessed at 3, 6, and 9 months from baseline.

    Baseline, then 3, 6, and 9 months from baseline

  • Change from baseline in the proportion of screen positive patients who received brief counseling

    Change from baseline in the number and percent of patients who screened positive for alcohol use disorder who then received brief counseling intervention. Change will be assessed at 3, 6, and 9 months from baseline.

    Baseline, then 3, 6, and 9 months from baseline

  • Change from baseline in the proportion of screen positive patients who received MAT

    Change from baseline in the number and percent of patients who screened positive for alcohol use disorder who then received medication assisted treatment (MAT) in the practice. Change will be assessed at 3, 6, and 9 months from baseline.

    Baseline, then 3, 6, and 9 months from baseline

  • Change from baseline in the proportion of screen positive patients referred to specialty clinics

    Change from baseline in the number and percent of patients who screened positive for alcohol use disorder who are then referred to specialty clinics. Change will be assessed at 3, 6, and 9 months from baseline.

    Baseline, then 3, 6, and 9 months from baseline

  • Change from baseline in the proportion of screen positive patients who received any treatment

    Change from baseline in the number and percent of patients who screened positive for alcohol use disorder who then receive at least one intervention. Change will be assessed at 3, 6, and 9 months from baseline.

    Baseline, then 3, 6, and 9 months from baseline

  • Estimated cost of providing virtual practice transformation support

    The costs of providing virtual practice transformation support with and without e-learning will be estimated for the 6-month intervention period. Cost of providing practice transformation support includes both the realized cost of delivering the practice transformation support and the opportunity cost to the practice of the time providers and other practice staff working with practice facilitators as well as working independently on implementation activities.

    Up to 6 months

Secondary Outcomes (2)

  • Change from baseline in the implementation of advanced primary care interventions

    Baseline and at 6 months from baseline

  • Change from baseline in the use of evidence-based alcohol use disorder (AUD) guidelines

    Baseline and at 6 months from baseline

Study Arms (2)

Virtual Practice Facilitation with e-Learning

ACTIVE COMPARATOR

A virtual practice facilitation intervention, with a practice facilitator working with practices in virtual one-on-one or group sessions utilizing alcohol use e-learning modules to guide and focus the process and content

Other: Virtual Practice Facilitation with e-Learning

Virtual Practice Facilitation without e-Learning

ACTIVE COMPARATOR

A virtual practice facilitation intervention, with a practice facilitator working with practices in virtual one-on-one or group sessions without utilizing alcohol use e-learning modules

Other: Virtual Practice Facilitation without e-Learning

Interventions

Virtual practice facilitation intervention using e-learning modules to guide the sessions includes: a. Practice Facilitator (PF) conducts 7 monthly virtual visits with each practice QI team i. Optional: PFs and practices may choose to conduct virtual facilitation in groups of up to 5 practices simultaneously b. MAT training (combination of virtual academic detailing plus online training resource) plus ongoing support to deal with questions through email and/or office hours with our project staff, experts, with additional consultation if needed with an addiction medicine specialist. c. Resources largely included as part of the e-learning module, but supplemented by online resource hub d. Centralized remote health information technology assistance, focused on implementation of registry functionality to track patients for population management and to report the measures required by AHRQ.

Also known as: Virtual practice facilitation intervention using e-learning
Virtual Practice Facilitation with e-Learning

Virtual practice facilitation intervention without e-learning to guide the sessions includes: a. Practice Facilitator (PF) conducts 7 monthly virtual visits with each practice QI team i. Optional: PFs and practices may choose to conduct virtual facilitation in groups of up to 5 practices simultaneously b. MAT training (virtual academic detailing) plus ongoing support to deal with questions through email and/or office hours with our project staff, experts, with additional consultation if needed with an addiction medicine specialist c. Online resource hub d. Centralized remote health information technology assistance, focused on implementation of registry functionality to track patients for population management and to report the measures required by AHRQ.

Also known as: Virtual practice facilitation intervention without e-learning modules
Virtual Practice Facilitation without e-Learning

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Practices that report they have fully implemented SBIRT (screening brief intervention referral and treatment) and MAT (medication assisted treatment) for AUD (alcohol use disorder) will be excluded. Clinicians and staff who do not speak or read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado at Denver and Health Sciences Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

AlcoholismAlcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Study Officials

  • W. Perry Dickinson, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This trial will investigate the superiority from an effectiveness perspective of: a) a virtual practice facilitation intervention, with a practice facilitator working with practices in virtual one-on-one or group sessions utilizing alcohol use e-learning modules to guide and focus the process and content, compared to b) a virtual practice facilitation intervention, with a practice facilitator working with practices in virtual one-on-one or group sessions without utilizing alcohol use e-learning modules.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 11, 2020

Study Start

May 26, 2020

Primary Completion

February 21, 2023

Study Completion

April 13, 2023

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations