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Records for Alcohol Care Enhancement: Addiction Research

2022 AUG 22 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- Staff editors report on the newly launched clinical trial, NCT05492942, which has the following summary description: “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.”

As a matter of record, on August 10, 2022, NewsRx staff editors report that the available information provided by Boston Medical Center on this trial include:

Tracking Information

Trial Identifier NCT05492942
First Submitted Date August 5, 2022
First Posted Date August 9, 2022
Results First Submitted Date Not Provided
Results First Posted Date Not Provided
Last Update Submitted Date August 5, 2022
Last Update Posted Date August 9, 2022
Primary Completion Date May 31, 2024
Start Date October 2022
Current Primary Outcome Measures •Percent Engaged in Alcohol Use Disorder (AUD) Treatment [ Time Frame: 48 days ] -- 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.
Current Secondary Outcome Measures •Percent Initiated in Alcohol Use Disorder (AUD) Treatment [ Time Frame: 14 Days ] -- 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 [ Time Frame: 90 Days ] -- 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) [ Time Frame: 90 Days ] -- 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) [ Time Frame: 90 Days ] -- 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 [ Time Frame: 90 Days ] -- 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 [ Time Frame: 90 Days ] -- 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 [ Time Frame: 90 Days ] -- 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 [ Time Frame: 90 Days ] -- 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.
Other Outcome Measures Not Provided
Change History Complete list of historical revisions of study NCT05492942

Descriptive Information

Brief Title Records for Alcohol Care Enhancement
Official Title Records for Alcohol Care Enhancement
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.
Detailed Description Not Provided
Study Type Interventional
Study Phase Not Applicable
Study Design Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Condition Alcohol Use Disorder (AUD)
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.
Other Names:
⚬BPA+PHM
•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.
Other Names:
⚬BPA+CCM
•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.
Other Names:
⚬BPA+PHM+CCM
Study Arms •Experimental: 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).
Interventions:
⚬Behavioral: Best Practice Advisory (BPA) and Clinical Care Management (CCM)
•Experimental: 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).
Interventions:
⚬Behavioral: Best Practice Advisory (BPA) and Population Health Management (PHM)
•Experimental: BPA plus Population Health Management plus Clinical Care Management (BPA+PHM+CC
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)
Interventions:
⚬Behavioral: Best Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care

Recruitment Information

Recruitment Status Not yet recruiting
Estimated Enrollment 128
Estimated Completion Date October 2024
Primary Completion Date May 31, 2024 (Final data collection date for primary outcome measure)
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).
Sex/Gender Sexes Eligible for Study: All
Ages 18 years and older
Accepts Healthy Volunteers Yes
Contacts Primary contact: Emily Hurstak, MD MPH, (617) 414 5951, [email protected]
Backup contact: Sarah Fielman, BS, (617) 358 1443, [email protected]
Listed Location Countries Not Provided
Removed Location Countries

Administrative Information

NCT Number NCT05492942
Other Study ID Numbers H-42631
4R33AA027597-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
Plan to Share Data No
Plan to Share Data (IPD) Description Not Provided
Responsible Party Boston Medical Center
Collaborators National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators Principal Investigator: Emily Hurstak, MD MPH, Boston Medical Center, General Internal Medicine
Information Provided By Boston Medical Center
Verification Date August 2022

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