STUN (STop UNhealthy) Alcohol Use Now! Implementing Evidence-Based Services for Unhealthy Alcohol Use in Primary Care (STUN)
Primary Purpose
Risky Health Behavior, Drinking, Alcohol, Alcohol Use Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practice Facilitation
Sponsored by
About this trial
This is an interventional health services research trial for Risky Health Behavior focused on measuring Alcohol, Screening, Counseling, Primary Care
Eligibility Criteria
Inclusion Criteria:
- Small-to-medium sized primary care practices (10 or fewer providers) in North Carolina
Exclusion Criteria:
- Practices with fewer than 100 adult patients (18+ years) or more than 10 providers;
- practices unwilling to implement evidence-based screening and management of patients with unhealthy alcohol use.
Sites / Locations
- Mountain AHEC
- Charlotte AHEC
- Greensboro AHEC
- Eastern AHEC
- Wake AHEC
- Area L AHEC
- Southeast AHEC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Practice Facilitation
Arm Description
All enrolled practices will receive practice facilitation for the duration of the intervention period.
Outcomes
Primary Outcome Measures
Number of adults screened for unhealthy alcohol use
number aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Number of adults screened for unhealthy alcohol use
number aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Number of adults screened for unhealthy alcohol use
number aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Percent of adults screened for unhealthy alcohol use
percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Percent of adults screened for unhealthy alcohol use
percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Percent of adults screened for unhealthy alcohol use
percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Secondary Outcome Measures
Number of adults with a positive screen for unhealthy alcohol use
Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result
Number of adults with a positive screen for unhealthy alcohol use
Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result
Number of adults with a positive screen for unhealthy alcohol use
Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result
Percent of adults with a positive screen for unhealthy alcohol use
Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result
Percent of adults with a positive screen for unhealthy alcohol use
Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result
Percent of adults with a positive screen for unhealthy alcohol use
Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result
Number of adults provided with brief counseling for risky drinking
Of those aged 18 or older who were identified as having unhealthy alcohol use, number who received brief counseling (based on documentation in the medical record)
Number of adults provided with brief counseling for risky drinking
Of those aged 18 or older who were identified as having unhealthy alcohol use, number who received brief counseling (based on documentation in the medical record)
Number of adults provided with brief counseling for risky drinking
Of those aged 18 or older who were identified as having unhealthy alcohol use, number who received brief counseling (based on documentation in the medical record)
Percent of adults provided with brief counseling for risky drinking
Of those aged 18 or older who were identified as having unhealthy alcohol use, percentage who received brief counseling (based on documentation in the medical record)
Percent of adults provided with brief counseling for risky drinking
Of those aged 18 or older who were identified as having unhealthy alcohol use, percentage who received brief counseling (based on documentation in the medical record)
Percent of adults provided with brief counseling for risky drinking
Of those aged 18 or older who were identified as having unhealthy alcohol use, percentage who received brief counseling (based on documentation in the medical record)
Number of adults identified as having alcohol use disorder (AUD)
After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)
Number of adults identified as having alcohol use disorder (AUD)
After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)
Number of adults identified as having alcohol use disorder (AUD)
After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)
Percent of adults identified as having alcohol use disorder (AUD)
After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)
Percent of adults identified as having alcohol use disorder (AUD)
After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)
Percent of adults identified as having alcohol use disorder (AUD)
After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)
Number of adults prescribed pharmacotherapy for AUD
After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Number of adults prescribed pharmacotherapy for AUD
After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Number of adults prescribed pharmacotherapy for AUD
After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Percent of adults with AUD who were prescribed pharmacotherapy for AUD
After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Percent of adults with AUD who were prescribed pharmacotherapy for AUD
After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Percent of adults with AUD who were prescribed pharmacotherapy for AUD
After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Number of adults with AUD referred to specialty care for AUD
After screening, number of adult patients identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Number of adults with AUD referred to specialty care for AUD
After screening, number of adult patients identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Number of adults with AUD referred to specialty care for AUD
After screening, number of adult patients identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Percent of adults with AUD referred to specialty care for AUD
After screening, percentage of adults identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Percent of adults with AUD referred to specialty care for AUD
After screening, percentage of adults identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Percent of adults with AUD referred to specialty care for AUD
After screening, percentage of adults identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Full Information
NCT ID
NCT04317989
First Posted
March 16, 2020
Last Updated
August 5, 2022
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT04317989
Brief Title
STUN (STop UNhealthy) Alcohol Use Now! Implementing Evidence-Based Services for Unhealthy Alcohol Use in Primary Care
Acronym
STUN
Official Title
The STUN (STop UNhealthy) Alcohol Use Now! Project: Using Practice Facilitation to Disseminate and Implement Patient-Centered Outcomes Research (PCOR) Evidence on Screening and Management of Unhealthy Alcohol Use in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
STUN Alcohol Use Now is an intervention designed to use primary care practice support services (practice facilitation) to help small to medium-size practices (10 or fewer providers) identify and provide services for people with unhealthy alcohol use. The original recruitment goal was 135 primary care practices in North Carolina, which we were unable to meet due to pandemic-related barriers.
Detailed Description
STUN Alcohol Use Now is an intervention designed to use primary care practice support services (practice facilitation or PF) to help small to medium-size practices (10 or fewer providers) identify and provide services for people with unhealthy alcohol use. 135 primary care practices in North Carolina will be recruited.
Specific Aim 1 will evaluate the effect of PF on uptake of evidence-based screening and brief intervention (SBI) for unhealthy alcohol use. The investigators hypothesize that PF will increase screening for unhealthy alcohol use and provision of brief counseling. The secondary hypothesis is that practice-level and contextual factors (capacity for quality improvement, organizational readiness to implement change, and implementation climate) will moderate the effect of PF on use of evidence-based screening and brief intervention (SBI) for unhealthy alcohol use.
Specific Aim 2 will evaluate whether PF increases provision, among those identified as having an alcohol use disorder (AUD), provision of medication assisted treatment (MAT) or referral to specialty care.
Aim 3 (effect of providing embedded telehealth services) will not be evaluated due to lower enrollment than anticipated and delayed data collection (both related to the COVID-19 pandemic) which have prevented randomization among practices with slower uptake of SBI after 6 months of PF.
In Aim 4 the investigators will evaluate the effect of PF on the implementation of clinical practice and office systems changes to improve evidence-based SBI and MAT. The primary hypothesis is that PF will increase implementation of clinical practice and office systems changes to improve evidence-based SBI and MAT. The secondary hypotheses are that (a) practice capacity for quality improvement (QI), organizational readiness to implement change, and contextual factors will moderate the effect of PF on the implementation of clinical practice and office systems changes and (b) embedded telehealth services will increase implementation of clinical practice and office systems changes among practices with slower uptake.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risky Health Behavior, Drinking, Alcohol, Alcohol Use Disorder, Drinking, Binge, Drinking Excessive
Keywords
Alcohol, Screening, Counseling, Primary Care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This trial will evaluate the effect of primary care practice facilitation on evidence-based screening, counseling, and Medication-Assisted Treatment (MAT). Practices are considered the participants; the intervention is conducted on the practice level. All enrolled practices receive the practice facilitation intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Practice Facilitation
Arm Type
Experimental
Arm Description
All enrolled practices will receive practice facilitation for the duration of the intervention period.
Intervention Type
Other
Intervention Name(s)
Practice Facilitation
Intervention Description
Implementing evidence-based protocols and the use of clinical algorithms (for screening, counseling, referral, and MAT) to engage the entire clinical team in a high standard delivery of care.
Promoting a strong use of decision support tools and templates to support the practice workflow.
Optimizing the use of the electronic health record (EHR) to pull clinical data on a monthly basis to guide the change process.
Developing patient registries (e.g., for those identified to have AUD) to identify needed care
Proactive, team-based care with assigned roles and responsibilities to prepare the clinical team to develop needed care and engage patients throughout the entire visit process.
Enhancing the understanding of available counseling and referral resources to ensure that practices are confident that they have appropriate evidence-based intervention options.
Primary Outcome Measure Information:
Title
Number of adults screened for unhealthy alcohol use
Description
number aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Time Frame
18 months
Title
Number of adults screened for unhealthy alcohol use
Description
number aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Time Frame
12 months
Title
Number of adults screened for unhealthy alcohol use
Description
number aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Time Frame
6 months
Title
Percent of adults screened for unhealthy alcohol use
Description
percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Time Frame
18 months
Title
Percent of adults screened for unhealthy alcohol use
Description
percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Time Frame
12 months
Title
Percent of adults screened for unhealthy alcohol use
Description
percent of those aged 18 or older who were screened with a validated tool for unhealthy alcohol use
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of adults with a positive screen for unhealthy alcohol use
Description
Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result
Time Frame
18 months
Title
Number of adults with a positive screen for unhealthy alcohol use
Description
Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result
Time Frame
12 months
Title
Number of adults with a positive screen for unhealthy alcohol use
Description
Of those aged 18 or older who were screened for unhealthy alcohol use, number who had a positive initial screening result
Time Frame
6 months
Title
Percent of adults with a positive screen for unhealthy alcohol use
Description
Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result
Time Frame
18 months
Title
Percent of adults with a positive screen for unhealthy alcohol use
Description
Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result
Time Frame
12 months
Title
Percent of adults with a positive screen for unhealthy alcohol use
Description
Of those aged 18 or older who were screened for unhealthy alcohol use, percentage who had a positive initial screening result
Time Frame
6 months
Title
Number of adults provided with brief counseling for risky drinking
Description
Of those aged 18 or older who were identified as having unhealthy alcohol use, number who received brief counseling (based on documentation in the medical record)
Time Frame
18 months
Title
Number of adults provided with brief counseling for risky drinking
Description
Of those aged 18 or older who were identified as having unhealthy alcohol use, number who received brief counseling (based on documentation in the medical record)
Time Frame
12 months
Title
Number of adults provided with brief counseling for risky drinking
Description
Of those aged 18 or older who were identified as having unhealthy alcohol use, number who received brief counseling (based on documentation in the medical record)
Time Frame
6 months
Title
Percent of adults provided with brief counseling for risky drinking
Description
Of those aged 18 or older who were identified as having unhealthy alcohol use, percentage who received brief counseling (based on documentation in the medical record)
Time Frame
18 months
Title
Percent of adults provided with brief counseling for risky drinking
Description
Of those aged 18 or older who were identified as having unhealthy alcohol use, percentage who received brief counseling (based on documentation in the medical record)
Time Frame
12 months
Title
Percent of adults provided with brief counseling for risky drinking
Description
Of those aged 18 or older who were identified as having unhealthy alcohol use, percentage who received brief counseling (based on documentation in the medical record)
Time Frame
6 months
Title
Number of adults identified as having alcohol use disorder (AUD)
Description
After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)
Time Frame
18 months
Title
Number of adults identified as having alcohol use disorder (AUD)
Description
After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)
Time Frame
12 months
Title
Number of adults identified as having alcohol use disorder (AUD)
Description
After screening, number of adult patients identified to have AUD (based on documented ICD diagnoses of AUD)
Time Frame
6 months
Title
Percent of adults identified as having alcohol use disorder (AUD)
Description
After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)
Time Frame
18 months
Title
Percent of adults identified as having alcohol use disorder (AUD)
Description
After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)
Time Frame
12 months
Title
Percent of adults identified as having alcohol use disorder (AUD)
Description
After screening, percentage of adult patients screened who were identified to have AUD (based on documented ICD diagnoses of AUD)
Time Frame
6 months
Title
Number of adults prescribed pharmacotherapy for AUD
Description
After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Time Frame
18 months
Title
Number of adults prescribed pharmacotherapy for AUD
Description
After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Time Frame
12 months
Title
Number of adults prescribed pharmacotherapy for AUD
Description
After screening, number of adult patients with AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Time Frame
6 months
Title
Percent of adults with AUD who were prescribed pharmacotherapy for AUD
Description
After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Time Frame
18 months
Title
Percent of adults with AUD who were prescribed pharmacotherapy for AUD
Description
After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Time Frame
12 months
Title
Percent of adults with AUD who were prescribed pharmacotherapy for AUD
Description
After screening, percent of adult patients identified as having AUD who receive evidence-based pharmacotherapy with naltrexone, acamprosate, disulfiram, or topiramate
Time Frame
6 months
Title
Number of adults with AUD referred to specialty care for AUD
Description
After screening, number of adult patients identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Time Frame
18 months
Title
Number of adults with AUD referred to specialty care for AUD
Description
After screening, number of adult patients identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Time Frame
12 months
Title
Number of adults with AUD referred to specialty care for AUD
Description
After screening, number of adult patients identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Time Frame
6 months
Title
Percent of adults with AUD referred to specialty care for AUD
Description
After screening, percentage of adults identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Time Frame
18 months
Title
Percent of adults with AUD referred to specialty care for AUD
Description
After screening, percentage of adults identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Time Frame
12 months
Title
Percent of adults with AUD referred to specialty care for AUD
Description
After screening, percentage of adults identified as having AUD who are referred to specialty care (e.g., psychiatry, CBT, motivational enhancement therapy, 12-step programs)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Small-to-medium sized primary care practices (10 or fewer providers) in North Carolina
Exclusion Criteria:
Practices with fewer than 100 adult patients (18+ years) or more than 10 providers;
practices unwilling to implement evidence-based screening and management of patients with unhealthy alcohol use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel E Jonas, MD, MPH
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darren Dewalt, MD, MPH
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mountain AHEC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803-2868
Country
United States
Facility Name
Charlotte AHEC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States
Facility Name
Greensboro AHEC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Eastern AHEC
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27835
Country
United States
Facility Name
Wake AHEC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27604-1657
Country
United States
Facility Name
Area L AHEC
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804-0368
Country
United States
Facility Name
Southeast AHEC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34784953
Citation
Jonas DE, Barclay C, Grammer D, Weathington C, Birken SA, DeWalt DA, Shoenbill KA, Boynton MH, Mackey M, Riley S, Cykert S. The STUN (STop UNhealthy) Alcohol Use Now trial: study protocol for an adaptive randomized trial on dissemination and implementation of screening and management of unhealthy alcohol use in primary care. Trials. 2021 Nov 16;22(1):810. doi: 10.1186/s13063-021-05641-7.
Results Reference
derived
Learn more about this trial
STUN (STop UNhealthy) Alcohol Use Now! Implementing Evidence-Based Services for Unhealthy Alcohol Use in Primary Care
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