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OpenTrials
Completed

NCT Number: NCT05492942

Records for Alcohol Care Enhancement

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.

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Key information

Conditions

Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Internal Medicine Primary Care Suites, BU Medical Campus

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Clinician Participants:

  • 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)

Inclusion criteria

for Patient Participants:

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.

Exclusion criteria

  • 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).

Treatment and study plan

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

Behavioral

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.

Other names: BPA+PHM

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

Behavioral

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.

Other names: BPA+CCM

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

Behavioral

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.

Other names: BPA+PHM+CCM

Primary outcomes

  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.

    Time frame: The outcome measure is assessed within 48 days following the date of the new AUD diagnosis, among patients 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).

Secondary outcomes

  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

    Time frame: The outcome measure is assessed within 14 days following the date of the new AUD diagnosis, among patients 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.

  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

    Time frame: Outcome measure is assessed 90 days following the date of the new AUD diagnosis, among patients 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.

  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.

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

    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.

  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.

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

    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.

  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.

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

    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.

  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.

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

    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.

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

    Time frame: The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients 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.

  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

    Time frame: The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: RACE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2022
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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