Clinical trial NCT04303676: Facilitating Alcohol Screening and Treatment (FAST)
Official title: Facilitating Alcohol Screening and Treatment (FAST), Colorado
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Primary Health Care
Alcohol Drinking
Quality Improvement
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the proportion of eligible patients screened for unhealthy alcohol use
timeFrame: Baseline, then 3, 6, and 9 months from baseline
measure: Change from baseline in the proportion of screen positive patients who received brief counseling
timeFrame: Baseline, then 3, 6, and 9 months from baseline
measure: Change from baseline in the proportion of screen positive patients who received MAT
timeFrame: Baseline, then 3, 6, and 9 months from baseline
measure: Change from baseline in the proportion of screen positive patients referred to specialty clinics
timeFrame: Baseline, then 3, 6, and 9 months from baseline
measure: Change from baseline in the proportion of screen positive patients who received any treatment
timeFrame: Baseline, then 3, 6, and 9 months from baseline
measure: Estimated cost of providing virtual practice transformation support
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change from baseline in the implementation of advanced primary care interventions
timeFrame: Baseline and at 6 months from baseline
measure: Change from baseline in the use of evidence-based alcohol use disorder (AUD) guidelines
timeFrame: Baseline and at 6 months from baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado at Denver and Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: W. Perry Dickinson, MD
role: PRINCIPAL_INVESTIGATOR
References: