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Improving Care for Unhealthy Alcohol Use in Primary Care

Primary Purpose

Alcohol Drinking, Alcohol Use Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practice facilitation implementation intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Drinking focused on measuring Unhealthy alcohol use, Alcohol misuse, Alcohol use disorder, Alcohol abuse, Alcohol dependence, Binge drinking, alcohol drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Veteran patients:

  • Veteran presenting for care at VA primary care site during pilot testing of the practice facilitation intervention, AND
  • Age 18 years and older.

Primary care providers:

  • Primary care staff who screen for unhealthy alcohol use and providers who practice at the primary care clinic at least 1 day per week.

Exclusion Criteria:

  • None.

Sites / Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Practice facilitation implementation intervention

Arm Description

6 months during which practice facilitation is implemented to support the primary care clinic in improving routine, population-based screening, assessment, treatment, and follow-up for unhealthy alcohol use and AUDs.

Outcomes

Primary Outcome Measures

Reach of alcohol-related care via electronic health record change
Reach outcomes will be expressed as a rate, with the denominator (for all outcomes) defined as all Veterans with a visit to the primary care site during active implementation of the practice facilitation pilot test. The numerator for each Reach outcome is as follows: the number of Veterans who screened positive for unhealthy alcohol use (AUDIT-C >= 5) AND had any documented brief intervention, specialty addictions treatment (inpatient and outpatient clinic visits for substance use disorder treatment encounters with an accompanying AUD diagnosis), or pharmacotherapy for AUD (any filled prescription for FDA-approved medications: acamprosate, disulfiram, or oral/injectable naltrexone) in the 30 days following a positive screen. Rates at the start of active implementation and at 3- and 6-months post Active Implementation will be calculated to examine change in Reach outcomes over time.
Adoption of alcohol-related care via electronic health record change
Adoption outcomes will be identified as the percentage of providers from the primary care clinic who deliver alcohol-related care when a Veteran screens positive for unhealthy alcohol use (e.g., delivery of brief interventions, consults to specialty addictions treatment, providing pharmacotherapy for AUDs). Rates of alcohol-related care at the start of active implementation and at 3- and 6-months post active implementation will be used to measure whether adoption rates of alcohol-related care increased over time.
Adoption of alcohol related care via self-report change
Brief self-report questions to determine whether providers have adopted the suggested evidence-based components of alcohol-related care (e.g., shared decision making, patient-centered discussions, setting goals with patients) will be administered at the start of the active implementation phase, at the end of the active implementation phase, and 3- and 6-months post practice facilitation.
Maintenance of alcohol-related care via electronic health record
Reach and Adoption outcomes using electronic health record data will be assessed again at 12-months post active implementation to examine whether high-quality alcohol care was sustained after practice facilitation.

Secondary Outcome Measures

Clinical Effectiveness via electronic health record
Examine whether Veterans' with an encounter in primary care during active implementation reduced their drinking 12-months post Active Implementation using AUDIT-C scores.

Full Information

First Posted
September 17, 2020
Last Updated
January 20, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04565899
Brief Title
Improving Care for Unhealthy Alcohol Use in Primary Care
Official Title
Implementation Intervention to Improve Care for Unhealthy Alcohol Use (CDA 20-057)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
December 2, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In order to improve the quality of alcohol-related care for those with unhealthy alcohol use, the current research will use an evidence-based implementation strategy, practice facilitation, at one VA primary care site to pilot test whether practice facilitation has the potential to improve the quality of primary care-based alcohol-related care . It is hypothesized that primary care providers who take part in the practice facilitation intervention will provide higher quality substance use care to Veterans with unhealthy alcohol use compared to care pre-practice facilitation (e.g., administer evidence-based brief counseling interventions at higher rates, prescribe alcohol use disorder pharmacotherapy at higher rates, increase referrals to specialty substance use disorder clinics).
Detailed Description
Alcohol use is a significant risk factor of disability and death for U.S. adults and one out of every six Veterans seen in primary care report unhealthy alcohol use. Based on substantial evidence from randomized controlled trials and the U.S. Preventive Services Task Force, VA/DoD clinical guidelines stipulate that all Veterans screening positive for unhealthy alcohol use should receive evidence-based alcohol care in primary care, including brief counseling interventions (BI) and additional treatment (e.g., pharmacotherapy) for those with alcohol use disorders (AUD). The VA was a pioneer in implementing alcohol screening and BI in primary care, yet substantial implementation gaps remain. In order to improve the quality and fidelity of alcohol-related care, the current research proposes to use an evidence-based implementation strategy, practice facilitation, at one VA to pilot test whether practice facilitation has the potential to improve quality of primary care-based alcohol-related care. The project will first conduct qualitative interviews assessing Veteran and clinical stakeholders to understand barriers and facilitators to high-quality alcohol care. Results from qualitative interviews will be used to refine and hone the practice facilitation intervention. Clinical stakeholders will then be recruited to participate in focus groups in order to evaluate the acceptability and feasibility of the proposed practice facilitation intervention prior to testing it. Last, a pilot test of the practice facilitation intervention will be conducted within one VA primary care clinic to understand whether practice facilitation improves the quality of primary care-based alcohol-related care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Use Disorder
Keywords
Unhealthy alcohol use, Alcohol misuse, Alcohol use disorder, Alcohol abuse, Alcohol dependence, Binge drinking, alcohol drinking

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot trial of an implementation strategy within one primary care clinic where all providers will be invited to participate
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Practice facilitation implementation intervention
Arm Type
Experimental
Arm Description
6 months during which practice facilitation is implemented to support the primary care clinic in improving routine, population-based screening, assessment, treatment, and follow-up for unhealthy alcohol use and AUDs.
Intervention Type
Other
Intervention Name(s)
Practice facilitation implementation intervention
Intervention Description
6 months during which practice facilitation is implemented to support the primary care clinic in improving routine, population-based screening, assessment, treatment, and follow-up for unhealthy alcohol use and AUDs.
Primary Outcome Measure Information:
Title
Reach of alcohol-related care via electronic health record change
Description
Reach outcomes will be expressed as a rate, with the denominator (for all outcomes) defined as all Veterans with a visit to the primary care site during active implementation of the practice facilitation pilot test. The numerator for each Reach outcome is as follows: the number of Veterans who screened positive for unhealthy alcohol use (AUDIT-C >= 5) AND had any documented brief intervention, specialty addictions treatment (inpatient and outpatient clinic visits for substance use disorder treatment encounters with an accompanying AUD diagnosis), or pharmacotherapy for AUD (any filled prescription for FDA-approved medications: acamprosate, disulfiram, or oral/injectable naltrexone) in the 30 days following a positive screen. Rates at the start of active implementation and at 3- and 6-months post Active Implementation will be calculated to examine change in Reach outcomes over time.
Time Frame
3- and 6-months post implementation intervention
Title
Adoption of alcohol-related care via electronic health record change
Description
Adoption outcomes will be identified as the percentage of providers from the primary care clinic who deliver alcohol-related care when a Veteran screens positive for unhealthy alcohol use (e.g., delivery of brief interventions, consults to specialty addictions treatment, providing pharmacotherapy for AUDs). Rates of alcohol-related care at the start of active implementation and at 3- and 6-months post active implementation will be used to measure whether adoption rates of alcohol-related care increased over time.
Time Frame
3- and 6-months post implementation intervention
Title
Adoption of alcohol related care via self-report change
Description
Brief self-report questions to determine whether providers have adopted the suggested evidence-based components of alcohol-related care (e.g., shared decision making, patient-centered discussions, setting goals with patients) will be administered at the start of the active implementation phase, at the end of the active implementation phase, and 3- and 6-months post practice facilitation.
Time Frame
3- and 6-months post implementation intervention
Title
Maintenance of alcohol-related care via electronic health record
Description
Reach and Adoption outcomes using electronic health record data will be assessed again at 12-months post active implementation to examine whether high-quality alcohol care was sustained after practice facilitation.
Time Frame
12-months post implementation intervention
Secondary Outcome Measure Information:
Title
Clinical Effectiveness via electronic health record
Description
Examine whether Veterans' with an encounter in primary care during active implementation reduced their drinking 12-months post Active Implementation using AUDIT-C scores.
Time Frame
12-months post implementation intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Veteran patients: Veteran presenting for care at VA primary care site during pilot testing of the practice facilitation intervention, AND Age 18 years and older. Primary care providers: Primary care staff who screen for unhealthy alcohol use and providers who practice at the primary care clinic at least 1 day per week. Exclusion Criteria: None.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel L. Bachrach, PhD MS
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Final data sets underlying publications resulting from the proposed research may be shared.
IPD Sharing Time Frame
After Oct. 1, 2025
IPD Sharing Access Criteria
A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The limited dataset will be made available following written (email) request to the PI.
Citations:
PubMed Identifier
35287714
Citation
Bachrach RL, Chinman M, Rodriguez KL, Mor MK, Kraemer KL, Garfunkel CE, Williams EC. Using practice facilitation to improve alcohol-related care in primary care: a mixed-methods pilot study protocol. Addict Sci Clin Pract. 2022 Mar 14;17(1):19. doi: 10.1186/s13722-022-00300-x.
Results Reference
derived

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Improving Care for Unhealthy Alcohol Use in Primary Care

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