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

Table 1 Schedule of enrollment, interventions, and measures

	Study Period^a
	Enrollment	Allocation	Intervention	Post Intervention
PCP Recruitment (emails and in-person)	X
PCP Informed Consent^b	X
PCP Baseline Survey^b	X
Randomization		X
EHR Supports (BPA)	X^c	X^c	X	X^c
PHM compiles and sends quarterly reports, and prompts front desk scheduling for patients on weekly report			X
CCM generates and reviews weekly reports, facilitates patient AUD care and provides direct patient interaction			X
CCM and PHM complete weekly fidelity to the intervention assessments			X
Study Team collects Medicaid Claims Data to Assess Trial Outcomes^b			X	X
Study team collects EHR data to assess trial outcomes^b			X	X
PCP Follow-up Survey^b				X

PCP = Primary Care Provider; EHR = Electronic Health Record; BPA = Best Practice Advisory; PHM = Population Health Manager; CCM = Clinical Care Manager; AUD = Alcohol Use Disorder. ^aAdverse events (AEs) and other unintended effects of trial interventions or trial conduct will not be collected systematically during the study period. The collection approach for AEs during the study period will be non-systematic assessment (i.e. AEs will be collected in response to spontaneous reports by participants). The study team (including the Principal Investigators) will assess any spontaneously reported AEs, and AEs will be reported to the Institutional Review Board. No concomitant care provided outside of the scope of the trial will be prohibited during the study period; routine clinical care will continue to be available to all patient participants throughout the duration of the trial. ^bAny personal information and identifiers collected during the study will be stored securely. As an additional protection, this study is covered by a Certificate of Confidentiality. ^c Electronic health record supports were designed and implemented during the preparatory phase of this project preceding the start of trial enrollment. These electronic health record supports for unhealthy alcohol use and alcohol use disorder are anticipated to remain in use by the clinic as part of standard clinic processes and electronic health record tools available to PCPs

ISSN: 1940-0640