Alcohol DrinkingNCT04248023
Screening and Management of Unhealthy Alcohol Use in Primary Care
A study testing Practice Facilitation in people with Alcohol Drinking and Alcohol Abuse, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
Unhealthy alcohol use is the third leading preventable cause of death in the United States. Yet, primary care physicians do not, on average, screen for and address unhealthy alcohol use in their patient populations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Abuse, Alcohol Use Disorder
- What is being tested?
- Practice Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,680 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2020to 31 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Practice Inclusion Criteria:
- Primary care practices
- Ambulatory care practices
Patient Inclusion Criteria:
- Patients 18 years and older and with an office visit at an included study site
Practice Exclusion Criteria:
- Practices that do not provide outpatient care
- Practices that do not provide primary care
Patient Exclusion Criteria:
- Patients under 18 years old
- Patients without an office visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Ambulatory Care Outcomes Research Network
Richmond, Virginia, 23298
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Practice Facilitation to Promote Evidence-based Screening and Management of Unhealthy Alcohol Use in Primary Care
Unhealthy alcohol use is the third leading preventable cause of death in the United States. Yet, primary care physicians do not, on average, screen for and address unhealthy alcohol use in their patient populations. By implementing practice changes to promote screening and treatment, patients stand to reduce unhealthy alcohol use and benefit from improved health outcomes. This project will provide a sample of Virginia primary care practices with a practice facilitator, practice specific resources, education on screening and counseling, and education on medication assisted therapy. The project will measure whether this change will improve screening rates and promote reduction of unhealthy alcohol use.
Read the detailed description
Unhealthy alcohol use is the third leading cause of preventable death in the US. Evidence shows that screening for unhealthy alcohol use and providing persons engaged in risky drinking with brief behavioral counseling interventions improves health outcomes, collectively termed screening and brief intervention (SBI). For moderate or severe alcohol use disorder (AUD), medication assistance therapy (MAT) is effective. Despite clear evidence of effectiveness, only 13% of primary care patients are screened with a standard instrument and only 6.7% of adults with AUD receive treatment. We believe that underutilization of SBI and MAT are driven by both a misunderstanding of the role and effectiveness of primary care in addressing unhealthy alcohol and limited practice resource and infrastructure. To promote the dissemination and implementation of evidence-based strategies to address unhealthy alcohol use throughout Virginia, we have extended our EvidenceNow collaboration to include addiction medicine experts at Virginia Commonwealth University, the Virginia Ambulatory Care Outcomes Research Network (ACORN), our state's family medicine residency training programs, and our state's Community Service Boards. We propose a practice-level cluster randomized trial with wait list control. 125 primary care practices in five regions throughout the state, each centered around a residency site for educational support, will receive a practice facilitation intervention to implement screening, counseling, and treatment for unhealthy alcohol at intervention start or 6-month delay. Guided by the identified EvidenceNow key drivers for change, practice support will include practice facilitation, education and training, shared learning and best practices, screening and counseling toolkits, data support, and assessment with feedback. Each practice will identify a clinician, nurse, and administrator champion to locally lead efforts and participate in learning collaboratives. Practices will design and implement screening, counseling, and treatment processes and operational changes, adapting their implementation strategy based on experiences and findings from other sites. We will conduct a mixed methods analysis. Primary outcomes will include the increase in screening for unhealthy alcohol use, increase in provision of brief counseling interventions and MAT, and reduction in alcohol intake for patients after practices receive practice facilitation. We will use the consolidated framework for implementation research to code and rate practice facilitation (e.g. dose, mode, reach) and practice implementation strategies (e.g. SBI and MAT strategies and tools implemented) on outcomes. Data sources will include practice facilitator field notes and interviews, chart reviews, patient survey, clinician survey, All Payer Claims Data, and qualitative interviews. We will administer the patient survey at baseline, 3 months, and 6 months after the intervention. Among patients age 18 to 75 with an office visit the prior month, we will randomly select 60 to survey. In addition to our internal evaluation, we will participate in the external collaborative evaluation and dissemination activities with AHRQ throughout the project.
- Conditions
- Alcohol Drinking, Alcohol Abuse, Alcohol Use Disorder
- Being tested
- Practice Facilitation
- Keywords
- Alcohol Misuse, Alcohol Abuse, Practice Facilitation, Motivational Interviewing, Preventive Services
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice FacilitationBehavioural
A practice facilitator will be assigned the each participating practice to assist with the development of a workflow, screening process, counseling resources, and referral resources for unhealthy alcohol use. Practices in control group will receive delayed intervention at 3 months after their matched cohort of practices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Practices | Experimental | Intervention practices will work with a practice facilitator to make practice specific changes to address unhealthy alcohol use. Receives: Behavioral: Practice Facilitation |
| Control Practices | No intervention | Control practices will continue to screening and address unhealthy alcohol use based on their existing practice patterns. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening for Unhealthy Alcohol Use
This outcome will evaluate the percent of patients who were screened in clinic or report screening for alcohol use (numerator = intervention patients sampled who received counseling/ denominator = intervention patients who did not receive counseling at 3 time points.)
Measured: 6 months
Treatment for Unhealthy Alcohol Use
This outcome will measure the percent of patients, screening positive for risky alcohol use, that receive any type of treatment including, but not limited to, counseling, brief intervention, motivational interviewing, referral, or medication assisted treatment.
Measured: 6 months
Secondary outcomes (1)
Reduction of Unhealthy Alcohol Use
This measure will identify the percent of patients with unhealthy alcohol use that have reduced alcohol intake after practice facilitation (numerator = number of sample patients with unhealthy alcohol use at baseline that received treatment / denominator = number of patients with unhealthy alcohol use at baseline.)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start15 Jul 2020
- Primary completion30 Jul 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a practice level randomized controlled trial. 125 practices across Virginia will receive the intervention (practice facilitation to enhance screening and treatment of unhealthy alcohol use (UAU)) or act as a control group (will receive practice facilitation at 3 month lag behind intervention groups.) The investigators will survey 60 patients from each practice at three time intervals to evaluate the current state and what changes are implemented and reported over the course of the study. An additional 60 patient chart review from each practice will be preformed. The investigators will use an implementation-effectiveness design to measure outcomes. Effectiveness outcomes include increased screening rate of patients; increased treatment of any kind for patients with UAU; and reduction of UAU. Implementation outcomes will include the barriers and facilitators to screening and evaluating for UAU.
- Masking
- None (open label)
- Enrolment
- 13,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander H Krist, MD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248023
- Sponsor's protocol ID
- HM20016728
- Other IDs
- 1R18HS027077-01
- Status last verified
- Jul 2023
- First submitted
- 27 Jan 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huffstetler AN, Villalobos G, Webel B, Rockwell MS, Funk A, Sabo RT, Epling JW, Brooks EM, Britz JB, Bortz BA, Svikis DS, Arias AJ, Tran RN, Krist AH. Practice Facilitation to Address Unhealthy Alcohol Use in Primary Care: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2024 Aug 2;5(8):e242371. doi: 10.1001/jamahealthforum.2024.2371.
PubMed 39120895Huffstetler AN, Kuzel AJ, Sabo RT, Richards A, Brooks EM, Lail Kashiri P, Villalobos G, Arias AJ, Svikis D, Bortz BA, Edwards A, Epling J, Cohen DJ, Parchman ML, Winter J, Wessler P, Yu TJ, Krist AH. Practice facilitation to promote evidence-based screening and management of unhealthy alcohol use in primary care: a practice-level randomized controlled trial. BMC Fam Pract. 2020 May 20;21(1):93. doi: 10.1186/s12875-020-01147-4.
PubMed 32434467
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Facilitation to Promote Evidence-based Screening and Management of Unhealthy Alcohol Use in Primary Care
- ClinicalTrials.gov ID
- NCT04248023
- Acronym / sponsor ID
- HM20016728
- Conditions
- Alcohol Drinking, Alcohol Abuse, Alcohol Use Disorder
- Keywords
- Alcohol Misuse, Alcohol Abuse, Practice Facilitation, Motivational Interviewing, Preventive Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,680 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 30 Jan 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.
Unhealthy alcohol use is the third leading preventable cause of death in the United States. Yet, primary care physicians do not, on average, screen for and address unhealthy alcohol use in their patient populations. By implementing practice changes to promote screening and treatment, patients stand to reduce unhealthy alcohol use and benefit from improved health outcomes. This project will provide a sample of Virginia primary care practices with a practice facilitator, practice specific resources, education on screening and counseling, and education on medication assisted therapy. The project will measure whether this change will improve screening rates and promote reduction of unhealthy alcohol use.
Detailed description
Unhealthy alcohol use is the third leading cause of preventable death in the US. Evidence shows that screening for unhealthy alcohol use and providing persons engaged in risky drinking with brief behavioral counseling interventions improves health outcomes, collectively termed screening and brief intervention (SBI). For moderate or severe alcohol use disorder (AUD), medication assistance therapy (MAT) is effective. Despite clear evidence of effectiveness, only 13% of primary care patients are screened with a standard instrument and only 6.7% of adults with AUD receive treatment. We believe that underutilization of SBI and MAT are driven by both a misunderstanding of the role and effectiveness of primary care in addressing unhealthy alcohol and limited practice resource and infrastructure. To promote the dissemination and implementation of evidence-based strategies to address unhealthy alcohol use throughout Virginia, we have extended our EvidenceNow collaboration to include addiction medicine experts at Virginia Commonwealth University, the Virginia Ambulatory Care Outcomes Research Network (ACORN), our state's family medicine residency training programs, and our state's Community Service Boards. We propose a practice-level cluster randomized trial with wait list control. 125 primary care practices in five regions throughout the state, each centered around a residency site for educational support, will receive a practice facilitation intervention to implement screening, counseling, and treatment for unhealthy alcohol at intervention start or 6-month delay. Guided by the identified EvidenceNow key drivers for change, practice support will include practice facilitation, education and training, shared learning and best practices, screening and counseling toolkits, data support, and assessment with feedback. Each practice will identify a clinician, nurse, and administrator champion to locally lead efforts and participate in learning collaboratives. Practices will design and implement screening, counseling, and treatment processes and operational changes, adapting their implementation strategy based on experiences and findings from other sites. We will conduct a mixed methods analysis. Primary outcomes will include the increase in screening for unhealthy alcohol use, increase in provision of brief counseling interventions and MAT, and reduction in alcohol intake for patients after practices receive practice facilitation. We will use the consolidated framework for implementation research to code and rate practice facilitation (e.g. dose, mode, reach) and practice implementation strategies (e.g. SBI and MAT strategies and tools implemented) on outcomes. Data sources will include practice facilitator field notes and interviews, chart reviews, patient survey, clinician survey, All Payer Claims Data, and qualitative interviews. We will administer the patient survey at baseline, 3 months, and 6 months after the intervention. Among patients age 18 to 75 with an office visit the prior month, we will randomly select 60 to survey. In addition to our internal evaluation, we will participate in the external collaborative evaluation and dissemination activities with AHRQ throughout the project.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a practice level randomized controlled trial. 125 practices across Virginia will receive the intervention (practice facilitation to enhance screening and treatment of unhealthy alcohol use (UAU)) or act as a control group (will receive practice facilitation at 3 month lag behind intervention groups.) The investigators will survey 60 patients from each practice at three time intervals to evaluate the current state and what changes are implemented and reported over the course of the study. An additional 60 patient chart review from each practice will be preformed. The investigators will use an implementation-effectiveness design to measure outcomes. Effectiveness outcomes include increased screening rate of patients; increased treatment of any kind for patients with UAU; and reduction of UAU. Implementation outcomes will include the barriers and facilitators to screening and evaluating for UAU.
| Arm | Type | Receives |
|---|---|---|
| Intervention Practices | Experimental | Behavioral: Practice FacilitationIntervention practices will work with a practice facilitator to make practice specific changes to address unhealthy alcohol use. |
| Control Practices | No intervention | –Control practices will continue to screening and address unhealthy alcohol use based on their existing practice patterns. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Practice FacilitationA practice facilitator will be assigned the each participating practice to assist with the development of a workflow, screening process, counseling resources, and referral resources for unhealthy alcohol use. Practices in control group will receive delayed intervention at 3 months after their matched cohort of practices. | Behavioural | Intervention Practices |
Primary outcome
Screening for Unhealthy Alcohol Use
Time frame: 6 months
This outcome will evaluate the percent of patients who were screened in clinic or report screening for alcohol use (numerator = intervention patients sampled who received counseling/ denominator = intervention patients who did not receive counseling at 3 time points.)
Treatment for Unhealthy Alcohol Use
Time frame: 6 months
This outcome will measure the percent of patients, screening positive for risky alcohol use, that receive any type of treatment including, but not limited to, counseling, brief intervention, motivational interviewing, referral, or medication assisted treatment.
1 secondary outcome
Reduction of Unhealthy Alcohol Use
Time frame: 6 months
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 25 Jul 2023.
- Derived from this study: PubMed 39120895Huffstetler AN, Villalobos G, Webel B, Rockwell MS, Funk A, Sabo RT, Epling JW, Brooks EM, Britz JB, Bortz BA, Svikis DS, Arias AJ, Tran RN, Krist AH. Practice Facilitation to Address Unhealthy Alcohol Use in Primary Care: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2024 Aug 2;5(8):e242371. doi: 10.1001/jamahealthforum.2024.2371.
- Derived from this study: PubMed 32434467Huffstetler AN, Kuzel AJ, Sabo RT, Richards A, Brooks EM, Lail Kashiri P, Villalobos G, Arias AJ, Svikis D, Bortz BA, Edwards A, Epling J, Cohen DJ, Parchman ML, Winter J, Wessler P, Yu TJ, Krist AH. Practice facilitation to promote evidence-based screening and management of unhealthy alcohol use in primary care: a practice-level randomized controlled trial. BMC Fam Pract. 2020 May 20;21(1):93. doi: 10.1186/s12875-020-01147-4.
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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.
Alexander H Krist, MD, MPH principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Facilitation in people with Alcohol Drinking and Alcohol Abuse, run by Virginia Commonwealth University at 2 sites 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?
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 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Screening for Unhealthy Alcohol Use (time frame: 6 months). The study lists 2 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 NCT04248023, which also lists 2 linked publications.
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 25 Jul 2023.