Alcohol Use DisorderFASTNCT04303676
Facilitating Alcohol Screening and Treatment (FAST)
A study testing Virtual Practice Facilitation with e-Learning and Virtual Practice Facilitation without e-Learning in people with Alcohol Use Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Virtual Practice Facilitation with e-Learning and Virtual Practice Facilitation without e-Learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2020to 13 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, 80045
About this study
Official title: Facilitating Alcohol Screening and Treatment (FAST), Colorado
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Virtual Practice Facilitation with e-Learning, Virtual Practice Facilitation without e-Learning
- Keywords
- Primary Health Care, Alcohol Drinking, Quality Improvement
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Practice Facilitation with e-LearningOther
Also called Virtual practice facilitation intervention using e-learning
Virtual practice facilitation intervention using e-learning modules to guide the sessions includes:
- 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.
- 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.
Virtual Practice Facilitation without e-LearningOther
Also called Virtual practice facilitation intervention without e-learning modules
Virtual practice facilitation intervention without e-learning to guide the sessions includes:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Virtual Practice Facilitation without e-Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and at 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start26 May 2020
- Primary completion21 Feb 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- W. Perry Dickinson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303676
- Sponsor's protocol ID
- 19-1348
- Other IDs
- 1R18HS027079-01
- Acronym
- FAST
- Status last verified
- Dec 2023
- First submitted
- 2 Mar 2020
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jortberg BT, Dickinson LM, Fernald DH, Bienstock A, de la Cerda D, Wiggins K, Swenson C, Halfacre J, Kirchner S, Dickinson WP. Improving Care for Unhealthy Alcohol Use: Results from the Facilitating Alcohol Screening and Treatment (FAST) Colorado Study. J Am Board Fam Med. 2024 Nov-Dec;37(6):1027-1037. doi: 10.3122/jabfm.2024.240048R1.
PubMed 40118544
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Alcohol Screening and Treatment (FAST), Colorado
- ClinicalTrials.gov ID
- NCT04303676
- Acronym / sponsor ID
- FAST / 19-1348
- Conditions
- Alcohol Use Disorder
- Keywords
- Primary Health Care, Alcohol Drinking, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 11 Mar 2020 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Practice Facilitation with e-Learning | Active comparator | Other: Virtual Practice Facilitation with e-LearningA 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 |
| Virtual Practice Facilitation without e-Learning | Active comparator | Other: Virtual Practice Facilitation without e-LearningA 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Virtual Practice Facilitation with e-LearningAlso: Virtual practice facilitation intervention using e-learningVirtual 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. | Other | Virtual Practice Facilitation with e-Learning |
| Virtual Practice Facilitation without e-LearningAlso: Virtual practice facilitation intervention without e-learning modulesVirtual 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. | Other | Virtual Practice Facilitation without e-Learning |
Primary outcome
Change from baseline in the proportion of eligible patients screened for unhealthy alcohol use
Time frame: Baseline, then 3, 6, and 9 months from baseline
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.
Change from baseline in the proportion of screen positive patients who received brief counseling
Time frame: Baseline, then 3, 6, and 9 months from baseline
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.
Change from baseline in the proportion of screen positive patients who received MAT
Time frame: Baseline, then 3, 6, and 9 months from baseline
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.
Change from baseline in the proportion of screen positive patients referred to specialty clinics
Time frame: Baseline, then 3, 6, and 9 months from baseline
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.
Change from baseline in the proportion of screen positive patients who received any treatment
Time frame: Baseline, then 3, 6, and 9 months from baseline
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.
Estimated cost of providing virtual practice transformation support
Time frame: Up to 6 months
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.
2 secondary outcomes
Change from baseline in the implementation of advanced primary care interventions
Time frame: Baseline and at 6 months from baseline
Change from baseline in the use of evidence-based alcohol use disorder (AUD) guidelines
Time frame: Baseline and at 6 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 40118544Jortberg BT, Dickinson LM, Fernald DH, Bienstock A, de la Cerda D, Wiggins K, Swenson C, Halfacre J, Kirchner S, Dickinson WP. Improving Care for Unhealthy Alcohol Use: Results from the Facilitating Alcohol Screening and Treatment (FAST) Colorado Study. J Am Board Fam Med. 2024 Nov-Dec;37(6):1027-1037. doi: 10.3122/jabfm.2024.240048R1.
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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. This study is not recruiting at the moment.
W. Perry Dickinson, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Practice Facilitation with e-Learning and Virtual Practice Facilitation without e-Learning in people with Alcohol Use Disorder, run by University of Colorado, Denver 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 18 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the proportion of eligible patients screened for unhealthy alcohol use (time frame: Baseline, then 3, 6, and 9 months from baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04303676, which also lists 1 linked publication.
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 18 Dec 2023.