Clinical trial NCT05492942: Records for Alcohol Care Enhancement
Official title: Records for Alcohol Care Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-08-09
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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).

Primary outcomes:
measure: Percent Engaged in Alcohol Use Disorder (AUD) Treatment
timeFrame: 48 days
Secondary outcomes:
measure: Percent Initiated in Alcohol Use Disorder (AUD) Treatment
timeFrame: 14 Days
measure: Percent Prescribed Alcohol Use Disorder (AUD) Medication
timeFrame: 90 Days
measure: Number of Outpatient Visits for Alcohol Use Disorder (AUD)
timeFrame: 90 Days
measure: Number of Visits with a BMC mental health clinician for Alcohol Use Disorder (AUD)
timeFrame: 90 Days
measure: Number of Referral(s) for Counseling or Specialty Alcohol Use Disorder (AUD) Care
timeFrame: 90 Days
measure: Number Completed Encounter for Alcohol Use Disorder (AUD) Specialty Care
timeFrame: 90 Days
measure: Number of Acute Care Utilization
timeFrame: 90 Days
measure: Number of Acute Care Utilization with an Alcohol-related Diagnosis
timeFrame: 90 Days
Other outcomes:
Locations:
city: Boston
country: United States
facility: General Internal Medicine Primary Care Suites, BU Medical Campus
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, General Internal Medicine
name: Emily Hurstak, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: