Records for Alcohol Care Enhancement

NCT05492942 | Completed Results

• 2 other identifiers: H-426314R33AA027597-03
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alcohol Use Disorder (AUD)

Keywords

Unhealthy alcohol use; Best Practice Advisory (BPA); Clinical care management (CCM); Population health management (PHM); Substance use disorder (SUD)

Outcome Measures

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.

  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).

  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)

• 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 outcome measure is assessed within 14 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

  Outcome measure is assessed 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 Who Are Empaneled to a Randomized Clinician.

  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 Who Are Empaneled to a Randomized Clinician.

  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 Within 90 Days of a New AUD Diagnosis, Among Patients Who Are Empaneled to a Randomized Clinician.

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

Study Arms (4)

Clinician prompting and Decision Support, Best Practice Advisory (BPA)

NO INTERVENTION

Access to an existing BPA for risky alcohol use and alcohol use disorder.

BPA plus Population Health Management (BPA+PHM)

EXPERIMENTAL

Access to the existing Epic BPA for risky alcohol use and alcohol use disorder + targeted support by a population health manager (PHM).

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

BPA plus Clinical Care Management (BPA+CCM)

EXPERIMENTAL

Access to the existing Epic BPA for risky alcohol use and alcohol use disorder + targeted support by a clinician care manager (CCM).

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

BPA plus Population Health Management plus Clinical Care Management (BPA+PHM+CCM)

EXPERIMENTAL

Access 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)

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

Interventions

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.

Also known as: BPA+PHM

BPA plus Population Health Management (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.

Also known as: BPA+CCM

BPA plus Clinical Care Management (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.

Also known as: BPA+PHM+CCM

BPA plus Population Health Management plus Clinical Care Management (BPA+PHM+CCM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

General Internal Medicine Primary Care Suites, BU Medical Campus

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 39910606 DERIVED

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Interventions

Population Health Management

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Emily Hurstak, MD MPH
• Organization: Boston Medical Center, Internal Medicine

emily.hurstak@bmc.org

(617) 414 5951

Study Officials

• Emily Hurstak, MD MPH

  Boston Medical Center, General Internal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: November 11, 2022
• Primary Completion: October 17, 2024
• Study Completion: November 28, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)