Can clinician champions reduce potentially inappropriate medications in people living with dementia? Study protocol for a cluster randomized trial

BACKGROUND: For people living with dementia (PLWD) the overuse of potentially inappropriate medications (PIMs) remains a persistent problem. De-prescribing trials in the elderly have mixed results. Clinician champions may be uniquely suited to lead efforts to address this challenge. Here we describe the study protocol for a 24-month embedded pragmatic cluster-randomized clinical trial within two accountable care organizations (ACOs) of such a clinician champion intervention. The specific aims are to (1) assess the effectiveness of a clinician champion on de-implementing PIMs in PLWD, (2) determine if the intervention is associated with a reduction in emergency department (ED) visits and hospitalizations attributed to a fall, and (3) examine five implementation outcomes: appropriateness, feasibility, fidelity, penetration, and equity. METHODS/DESIGN: Two ACOs agreed to participate: United States Medical Management (USMM) and Oschner Health System. The unit of randomization will be the primary care clinic. A clinician champion will be recruited from each of the intervention clinics to participate in a 6-month training program and then work with clinicians and staff in their clinic for 12 months to reduce the use of PIMs in their PLWD population. For aims 1 and 2, Medicare claims data will be used to assess outcomes. The outcome for aim #1 will be medication possession rates per quarter, for the three therapeutic classes of PIMs among patients with dementia in intervention clinics versus control clinics. For aim #2, we will assess the incidence of falls using a previously validated algorithm. For both aims 1 and 2, we will construct hierarchical models with time period observations nested within patient using generalized estimating equations (GEE) with robust standard errors. The key variable of interest will be the treatment indicator assigned based on practice. For aim #3, we will conduct qualitative thematic analysis of documentation by the clinician champions in their project workbooks to evaluate the five implementation outcomes. DISCUSSION: This embedded pragmatic trial will add to our existing knowledge regarding the effectiveness of a clinician champion strategy to de-prescribe potentially inappropriate medication among patients with dementia as well as its appropriateness, feasibility, fidelity, penetration, and equity. TRIAL REGISTRATION: Clinicaltrials.govNCT05359679, Registered May 4, 2022