Records for Alcohol Care Enhancement

Alcohol Use Disorder (AUD) Clinical Trial

— RACE  

Official title:

Records for Alcohol Care Enhancement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05492942
• Other study ID #: H-42631
• Secondary ID: 4R33AA027597-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

The study team created a live database/registry of patients with unhealthy alcohol use in the 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 134
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism

Intervention

Behavioral:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	General Internal Medicine Primary Care Suites, BU Medical Campus	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Engaged in Alcohol Use Disorder (AUD) Treatment	The percent of patients engaged in AUD treatment among patients with a new AUD diagnosis on a 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 the emergency department/detox.	48 days
Secondary	Percent Initiated in Alcohol Use Disorder (AUD) Treatment	The percent of patients initiated in AUD treatment among patients with a new AUD diagnosis on a clinician's panel. Initiation is defined as having a healthcare service (inclusive of medication) with a diagnosis of 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.	14 Days
Secondary	Percent Prescribed Alcohol Use Disorder (AUD) Medication	The percent of patients who have been prescribed AUD medication such as Naltrexone, Intramuscular (IM) Naltrexone, Acamprosate, Disulfiram, or Topiramate within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis on a clinician's panel.	90 Days
Secondary	Number of Outpatient Visits for Alcohol Use Disorder (AUD)	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 on a clinician's panel.	90 Days
Secondary	Number of Visits with an Integrated Behavioral Health Social Worker for Alcohol Use Disorder (AUD)	Number of visits with a BMC integrated behavioral health social worker with an AUD diagnosis (encounter with AUD as a billing diagnosis) within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis on a clinician's panel.	90 Days
Secondary	Number of Referral(s) for Counseling or Specialty Alcohol Use Disorder (AUD) Care	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 on a clinician's panel.	90 Days
Secondary	Number Completed Encounter for Alcohol Use Disorder (AUD) Specialty Care	Number of completed encounters for AUD specialty care in the electronic health record (EHR) within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis on a clinician's panel.	90 Days
Secondary	Number of Acute Care Utilization	Number of acute care utilization encounters (emergency department visits and hospitalizations) within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis on a clinician's panel.	90 Days
Secondary	Number of Acute Care Utilization with an Alcohol-related Diagnosis	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 a clinician's panel.	90 Days