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Alcohol Use Disorder (AUD)RACENCT05492942

Records for Alcohol Care Enhancement

A study testing Best Practice Advisory (BPA) and Population Health Management (PHM), Best Practice Advisory (BPA) and Clinical Care Management (CCM) and Best Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care Management (CCM) in people with Alcohol Use Disorder (AUD), run by Boston Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Unhealthy alcohol use (the spectrum from risky consumption through alcohol use disorder, AUD) is a leading cause of preventable death in the US (88,424 deaths annually costing $249 billion a year), and alcohol-related health harms (e.g. AUD itself, cirrhosis) are increasing. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder (AUD)
What is being tested?
Best Practice Advisory (BPA) and Population Health Management (PHM), Best Practice Advisory (BPA) and Clinical Care Management (CCM) and Best Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care Management (CCM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteUnited States
Study dates
11 Nov 2022to 28 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Adult (18 years or older)
  • Physician or Nurse Practitioner
  • Practices Primary Care at Boston Medical Center in the General Internal Medicine (GIM) Primary Care Clinic
  • Current position in the practice expected to be unchanged for a minimum of 18 months (not a graduating trainee)
  • Records (EHR, Medicaid accountable care organizations (ACO) claims) from all patients empaneled (patient is assigned to PCP's primary care panel) by study enrolled clinicians who are:
  • Adult (18 years or older)
  • Have had at least 1 completed visit in general internal medicine at BMC during the last 18 months.

Who cannot join

  • Clinicians who, at the time of study recruitment, are expected to remain in their BMC GIM position for less than 18 months (e.g. resident or fellow trainees expected to graduate within the study time period).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • General Internal Medicine Primary Care Suites, BU Medical Campus

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Unhealthy alcohol use (the spectrum from risky consumption through alcohol use disorder, AUD) is a leading cause of preventable death in the US (88,424 deaths annually costing $249 billion a year), and alcohol-related health harms (e.g. AUD itself, cirrhosis) are increasing. Despite high frequency of contacts with the medical system, most people with unhealthy alcohol use do not receive evidence-based interventions due to factors such as stigma, lack of knowledge, challenges with implementing and maintaining tool-based screening, time or prioritization constraints, and more.

Electronic health records (EHRs), Best Practice Advisories (BPA) and registries are known and practical tools to improve management and care of chronic disease by aggregating information about the target population, and by assisting the clinician in reminders, decision support, and disease-specific care management. EHRs may help clinicians identify, assess, treat and monitor care when assisted by targeted staff support such as a clinical care manager (CCM) and population health manager (PHM). These support staff help to track outcomes of care and treatments, allowing for increased engagement with the population, and facilitation of care.

Read the detailed description

The study team created a live database/registry of patients with unhealthy alcohol use in the Boston Medical Center (BMC) electronic health record (Epic), and updated Epic-based best practice advisories (BPA) and clinical decision support (CDS) (Epic Smart Set) for risky alcohol use and AUD. To improve recognition, management, and overall services provided to patients with AUD, this trial aims to test the impact of these EHR tools (the BPA, CDS, registry and registry-based reporting) for risky alcohol use and AUD by incorporating a population health manager (PHM) and clinical care manager (CCM) to augment reach and support to clinicians, and test the feasibility and effectiveness of leveraging EHRs and targeted supports to improve AUD care. A four-group randomized control trial will be implemented to determine which of four interventions is most effective at increasing rates of initiation and engagement in AUD treatment, as well as other clinical processes and outcomes. The trial will compare the use of the 1) BPA alone (only Epic-based clinician prompting and CDS), 2) BPA + PHM, 3) BPA + CCM, and 4) BPA + PHM + CCM, on the trials' primary, secondary, and exploratory outcomes. Trial results will be assessed by examining outcomes for patients on the clinician's panel.

Being tested
Best Practice Advisory (BPA) and Population Health Management (PHM), Best Practice Advisory (BPA) and Clinical Care Management (CCM), Best Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care Management (CCM)
Keywords
Unhealthy alcohol use, Best Practice Advisory (BPA), Clinical care management (CCM), Population health management (PHM), Substance use disorder (SUD)
Medical subject headings
Alcoholism, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best Practice Advisory (BPA) and Population Health Management (PHM)Behavioural

    Also called BPA+PHM

    A clinician will have continued access to the existing Epic BPA that provides clinical decision support and management for risky alcohol use and alcohol use disorder (AUD). Additionally, a clinician will be supported by a PHM who can access and existing registry of patients with possible or confirmed AUD to examine quality metrics for patients with an AUD on the provider panel. The PHM will circulate quarterly reports to the clinicians in this group to provide performance metric data that indicates the proportion of patients on their primary care panel who are initiating and engaging in AUD treatment. Additionally, the PHM will circulate a weekly report of higher risk patients on the clinician's panel who recently had an acute care visit for AUD and could benefit from outreach for follow-up care. PHM does not directly help clinicians with implementation of care with individual patients, and has no direct patient contact.

  • Best Practice Advisory (BPA) and Clinical Care Management (CCM)Behavioural

    Also called BPA+CCM

    A clinician will have continued access to the existing Epic BPA that provides clinical decision support and management for risky alcohol use and alcohol use disorder (AUD). The clinician will be supported by a CCM who will assist in identifying patients who need further assessment on the clinician patient panel. The CCM will conduct outreach to patients regarding alcohol use care, and will communicate with the clinician to help decide potential care plans, and then assist in implementing those plans for patients. The CCM has expertise on how to provide appropriate care to patients and can help patients navigate the complex care system. Further assistance by the CCM may include facilitating prescriptions for clinician sign-off, assuring refills, finding, selecting and coordinating specialty AUD care, and contacting patients to make appointments.

  • Best Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care Management (CCM)Behavioural

    Also called BPA+PHM+CCM

    A clinician will have continued access to the existing Epic BPA that provides clinical decision support and management for risky alcohol use and alcohol use disorder (AUD). Additionally, a clinician will be supported by a PHM and clinical care manager CCM. The PHM can access and existing registry of patients with possible or confirmed alcohol use disorder to examine quality metrics for patients with an alcohol use disorder on the provider panel. The PHM will circulate quarterly reports to the clinicians in this group to provide summaries of data of those who have initiated or engaged in treatment for alcohol use, as well as a weekly report of higher risk patients on their panel who recently had an acute care visit for AUD and could benefit from outreach for follow-up care. The CCM will assist in identifying patients who need further assessment, and will assist in conducting outreach and implementing care to those patients regarding alcohol use care.

Study groups in NCT05492942
Study groupRoleWhat they receive
Clinician prompting and Decision Support, Best Practice Advisory (BPA)No interventionAccess to an existing BPA for risky alcohol use and alcohol use disorder.
BPA plus Population Health Management (BPA+PHM)ExperimentalAccess to the existing Epic BPA for risky alcohol use and alcohol use disorder + targeted support by a population health manager (PHM).
Receives: Behavioral: Best Practice Advisory (BPA) and Population Health Management (PHM)
BPA plus Clinical Care Management (BPA+CCM)ExperimentalAccess to the existing Epic BPA for risky alcohol use and alcohol use disorder + targeted support by a clinician care manager (CCM).
Receives: Behavioral: Best Practice Advisory (BPA) and Clinical Care Management (CCM)
BPA plus Population Health Management plus Clinical Care Management (BPA+PHM+CCM)ExperimentalAccess to the existing Epic BPA risky alcohol use and alcohol use disorder + targeted support by a population health manager (PHM) and clinician care manager (CCM)
Receives: Behavioral: Best Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care Management (CCM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Engagement Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.

    The percent of new AUD diagnosis episodes that meet criteria for AUD treatment engagement among patients with a new AUD diagnosis on a randomized clinician's panel. Engagement is defined as having two or more healthcare services (inclusive of AUD medication) with a diagnosis of AUD within 34 days of meeting initiation, which is defined as having a healthcare service for AUD within 14 days of a new AUD diagnosis. A new AUD diagnosis is defined as a health service in which a patient receives a new AUD diagnosis when there has not been an AUD diagnosis during the prior 194 days, excluding diagnoses assigned in emergency department/detox.

    Outcome is reported at the empaneled patient level.

    Outcome measure time frame is based on definitions of initiation and engagement. Engagement is assessed within 34 days following treatment initiation, and initiation is assessed within 14 days of a new AUD diagnosis (34 days + 14 days =a maximum possible outcome measure time frame of 48 days).

    Measured: The outcome measure is assessed within 48 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

Secondary outcomes (8)
  1. Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Initiation Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians

    The percent of new AUD diagnosis episodes that meet criteria for AUD treatment initiation among patients with a new AUD diagnosis on a randomized clinician's panel. Initiation is defined as having a healthcare service for AUD within 14 days of a new AUD diagnosis. A new AUD diagnosis is defined as a health service in which a patient receives a new AUD diagnosis when there has not been an AUD diagnosis during the prior 194 days, excluding diagnoses assigned in the emergency department/detox.

    Outcome is reported at the empaneled patient level.

    Outcome measure time frame is based on definitions of initiation. Initiation is assessed within 14 days of a new AUD diagnosis (14 days is the maximum possible outcome measure time frame).

    Outcome is assessed in Medicaid claims.

    Measured: The outcome measure is assessed within 14 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

  2. Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes Within Which an AUD Medication is Prescribed Within 90 Days of the New AUD Diagnosis Among Patients Who Are Empaneled to Randomized Clinicians

    Percent of new Alcohol Use Disorder (AUD) diagnosis episodes within which an AUD medication is prescribed within 90 days of the new AUD diagnosis among patients who are empaneled to randomized clinicians

    AUD medications include: Naltrexone, Intramuscular (IM) Naltrexone, Acamprosate, or Disulfiram.

    Outcome is reported at the new AUD diagnosis episode level among patients empaneled to randomized clinicians.

    Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.

    Measured: Outcome measure is assessed 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

  3. Number of Boston Medical Center (BMC) Outpatient Encounters With an AUD Billing Diagnosis Within 90 Days of a New AUD Diagnosis, Among Patients Who Are Empaneled to a Randomized Clinician.

    Number of Boston Medical Center (BMC) outpatient encounters with an AUD billing diagnosis within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician.

    Outcome is reported at the new AUD diagnosis episode level.

    Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.

    Measured: The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

  4. Number of BMC Mental Health Clinician Encounters With an AUD Billing Diagnosis Within 90 Days of a New AUD Diagnosis, Among Patients Who Are Empaneled to a Randomized Clinician.

    Number of BMC mental health clinician encounters with an AUD billing diagnosis within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician.

    Outcome is reported at the empaneled patient level.

    Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.

    Measured: The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

  5. Number of Referrals for Counseling or Specialty AUD Care Within 90 Days of a New AUD Diagnosis, Among Patients Who Are Empaneled to a Randomized Clinician.

    Number of referrals for counseling or specialty AUD care such as the BMC Office Based Addiction Treatment (OBAT), Center for Addiction Treatment for AdoLescent/Young adults who use SubsTances (CATALYST), etc., within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician.

    Outcome is reported at the empaneled patient level.

    Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.

    Measured: The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

  6. Number of BMC AUD Specialty Care Encounters With an AUD Billing Diagnosis Within 90 Days of a New AUD Diagnosis, Among Patients Who Are Empaneled to a Randomized Clinician.

    Number of BMC AUD specialty care encounters with an AUD billing diagnosis within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician.

    Outcome is reported at the empaneled patient level.

    Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.

    Measured: The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

  7. Number of Acute Care Encounters Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.

    Number of acute care encounters (emergency department visits and hospitalizations) within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician.

    Outcome is reported at the empaneled patient level.

    Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.

    Outcome is assessed in Medicaid claims.

    Measured: The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

  8. Number of Acute Care Utilization Encounters With an Alcohol-related Diagnosis Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians

    Number of acute care utilization encounters (emergency department visits and hospitalizations), with an alcohol-related diagnosis within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis on are empaneled to a randomized clinician.

    Outcome is reported at the empaneled patient level.

    Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.

    Outcome is assessed in Medicaid claims.

    Measured: The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2022
  2. Study start11 Nov 2022
  3. Primary completion17 Oct 2024
  4. Study completion28 Nov 2024

Resources

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
Factorial
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05492942
Sponsor's protocol ID
H-42631
Other IDs
4R33AA027597-03
Acronym
RACE
Status last verified
Oct 2025
First submitted
5 Aug 2022
Last updated
10 Nov 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Magane KM, Saitz R, Fielman S, LaRochelle MR, Shanahan CW, Pace CA, LaValley M, Penington K, Karzhevsky S, Hurstak E. Supporting primary care clinicians in caring for patients with alcohol use disorder: study protocol for Records for Alcohol Care Enhancement (RACE), a factorial four-arm randomized trial. Addict Sci Clin Pract. 2025 Feb 5;20(1):9. doi: 10.1186/s13722-024-00526-x.

    PubMed 39910606

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice Advisory (BPA) and Population Health Management (PHM), Best Practice Advisory (BPA) and Clinical Care Management (CCM) and Best Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care Management (CCM) in people with Alcohol Use Disorder (AUD), run by Boston Medical Center 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 7 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 10 Nov 2025. 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?

Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Engagement Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians. (time frame: The outcome measure is assessed within 48 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.). 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 NCT05492942, 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 10 Nov 2025.

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