An interventional study of Virtual Practice Facilitation with e-Learning and Virtual Practice Facilitation without e-Learning in Alcohol Use Disorder, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research
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.
Alcohol use causes an estimated 88,000 deaths yearly and is the third leading cause of mortality in the U.S. Unhealthy alcohol use, a spectrum from risky drinking to alcohol use disorder (AUD), impacts 27% of adults, with high cost to the health care system. Evidence-based guidelines exist for identification and treatment of unhealthy alcohol use, and evidence supports the effectiveness of medication-assisted therapy (MAT). Primary care is recognized as an ideal context for the implementation of screening and treatment processes. Despite the evidence, significant gaps exist in uptake into practice.
Practice facilitation has emerged as a key method for assisting practices in implementing organizational changes and improvements. However, in-person practice facilitation is time-intensive and costly, and virtual facilitation has not been as effective as in-person. E-learning modules can provide a structure for quality improvement in a clinical area. A pilot using e-learning combined with virtual practice facilitation was very successful from the perspectives of both practice facilitators and practices. We believe that virtual practice facilitation using e-learning modules to focus the content and process has great potential as a less costly and equally effective method compared to in-person facilitation.
In this "Facilitating Alcohol Screening and Treatment (FAST) Colorado" proposal, we will perform a cluster randomized trial to examine the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and relative value of two approaches to supporting primary care practices to implement PCOR findings to improve their identification and treatment management of unhealthy alcohol use among adults, including screening, brief intervention, medication assisted therapy, and referral to treatment. 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. We will identify key practice characteristics and other contextual factors that impact the response of practices to the two practice interventions. We will compare the adaptability, trialability, and scalability of the two interventions in order to plan dissemination of the findings to key local, regional, and national stakeholders, including sharing ongoing lessons learned and resources with other programs supporting practice transformation.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 399 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Individual patients are not directly enrolled in this study.
Practice inclusion criteria are: 1) family medicine or general internal medicine practices, generally with no more than 10 clinicians; 2) practices must be either independent or, if part of a larger organization, demonstrate that they do not receive significant QI support from the larger organization; and 3) practices must demonstrate commitment to participate fully in the intervention and evaluation, as carefully described and agreed to in a signed practice agreement. Practices with integrated behavioral health services will be included if the practice application indicates an overall level of implementation of SBIRT (screening brief intervention referral and treatment) and MAT (medication assisted treatment) that leaves room for improvement.
Exclusion Criteria:
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
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
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
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 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Change from baseline in the implementation of advanced primary care interventions
Comprehensive Primary Care Practice Monitor survey will assess practice-level implementation of the Building Blocks of High-performing Primary Care. Change will be assessed at 6 months from baseline.
Time frame: Baseline and at 6 months from baseline
Change from baseline in the use of evidence-based alcohol use disorder (AUD) guidelines
Practice-level assessment of (screening brief intervention referral and treatment) SBIRT and MAT activities, along with other activities aimed at AUD. An implementation checklist is completed in each practice. Change will be assessed at 6 months from baseline.
Time frame: Baseline and at 6 months from baseline
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver