Trial design
SECONDARY
This trial is a 5-year hybrid type 2 randomized controlled trial funded by the Agency for Healthcare Research and Quality (AHRQ) and designed to evaluate the management of pediatric polypharmacy in the primary care setting by comparing the pMTM intervention to usual care for lowering the primary outcome of MRP counts and secondary outcomes of symptom burdens and acute healthcare utilization. Because pediatric pharmacist support is currently a limited resource, a hybrid type 2 design is the most efficient, rigorous design to simultaneously evaluate the effectiveness and implementation of pMTM to enable rapid dissemination [All study procedures were reviewed and approved by the affiliated Institutional Review Board (IRB). Protocol amendments will be approved by the local IRB. Other pertinent parties will be notified through updates to the clinicaltrials.gov website. All publications related to the study will include a summary of protocol amendments.