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Records for Alcohol Care Enhancement (RACE)

Primary Purpose

Alcohol Use Disorder (AUD)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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)
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Use Disorder (AUD) focused on measuring Unhealthy alcohol use, Best Practice Advisory (BPA), Clinical care management (CCM), Population health management (PHM), Substance use disorder (SUD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • General Internal Medicine Primary Care Suites, BU Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

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

BPA plus Population Health Management (BPA+PHM)

BPA plus Clinical Care Management (BPA+CCM)

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 5, 2022
Last Updated
August 15, 2023
Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05492942
Brief Title
Records for Alcohol Care Enhancement
Acronym
RACE
Official Title
Records for Alcohol Care Enhancement
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)
Keywords
Unhealthy alcohol use, Best Practice Advisory (BPA), Clinical care management (CCM), Population health management (PHM), Substance use disorder (SUD)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinician prompting and Decision Support, Best Practice Advisory (BPA)
Arm Type
No Intervention
Arm Description
Access to an existing BPA for risky alcohol use and alcohol use disorder.
Arm Title
BPA plus Population Health Management (BPA+PHM)
Arm Type
Experimental
Arm Description
Access to the existing Epic BPA for risky alcohol use and alcohol use disorder + targeted support by a population health manager (PHM).
Arm Title
BPA plus Clinical Care Management (BPA+CCM)
Arm Type
Experimental
Arm Description
Access to the existing Epic BPA for risky alcohol use and alcohol use disorder + targeted support by a clinician care manager (CCM).
Arm Title
BPA plus Population Health Management plus Clinical Care Management (BPA+PHM+CCM)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Best Practice Advisory (BPA) and Population Health Management (PHM)
Other Intervention Name(s)
BPA+PHM
Intervention Description
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
Intervention Name(s)
Best Practice Advisory (BPA) and Clinical Care Management (CCM)
Other Intervention Name(s)
BPA+CCM
Intervention Description
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
Intervention Name(s)
Best Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care Management (CCM)
Other Intervention Name(s)
BPA+PHM+CCM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Engaged in Alcohol Use Disorder (AUD) Treatment
Description
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.
Time Frame
48 days
Secondary Outcome Measure Information:
Title
Percent Initiated in Alcohol Use Disorder (AUD) Treatment
Description
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.
Time Frame
14 Days
Title
Percent Prescribed Alcohol Use Disorder (AUD) Medication
Description
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.
Time Frame
90 Days
Title
Number of Outpatient Visits for Alcohol Use Disorder (AUD)
Description
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.
Time Frame
90 Days
Title
Number of Visits with an Integrated Behavioral Health Social Worker for Alcohol Use Disorder (AUD)
Description
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.
Time Frame
90 Days
Title
Number of Referral(s) for Counseling or Specialty Alcohol Use Disorder (AUD) Care
Description
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.
Time Frame
90 Days
Title
Number Completed Encounter for Alcohol Use Disorder (AUD) Specialty Care
Description
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.
Time Frame
90 Days
Title
Number of Acute Care Utilization
Description
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.
Time Frame
90 Days
Title
Number of Acute Care Utilization with an Alcohol-related Diagnosis
Description
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.
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Hurstak, MD MPH
Organizational Affiliation
Boston Medical Center, General Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Internal Medicine Primary Care Suites, BU Medical Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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