Records for Alcohol Care Enhancement

NCT ID: NCT05492942

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2024-11-28

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.

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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

BPA plus Population Health Management (BPA+PHM)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

BPA plus Clinical Care Management (BPA+CCM)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

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)

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Other Intervention Names

BPA+PHM; BPA+CCM; BPA+PHM+CCM

Eligibility Criteria

Inclusion Criteria

• 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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Hurstak, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, General Internal Medicine

Locations

General Internal Medicine Primary Care Suites, BU Medical Campus

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39910606 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

4R33AA027597-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-42631

Identifier Type: -

Identifier Source: org_study_id