Optimizing the Clinical Management of Polypharmacy for Children with Medical Complexity

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PROJECT SUMMARY/ABSTRACT Optimal health for children with medical complexity (CMC) often depends on exposure to pediatric polypharmacy (≥5 concurrent medications). Medication-related problems (MRPs), like inappropriate therapy, undertreated symptoms, or adverse drug events, can lead to emergency visits or hospitalizations. Yet, during routine clinical care for CMC, polypharmacy is infrequently assessed and rarely managed comprehensively. To improve medication-related patient outcomes, safety, and value, a new approach is needed to manage polypharmacy in the priority population of CMC. Pharmacist-led medication therapy management (MTM) is a proven and effective tool for managing adult and geriatric polypharmacy. Our scientific premise is that a structured pharmacist-led Pediatric Medication Therapy Management (pMTM) intervention will improve the proactive management of polypharmacy by directly addressing major gaps in current practice. The implementation of pMTM to address pediatric MRPs thus represents innovation based on an established foundation. We propose a hybrid type 2 randomized controlled trial (RCT) of a pMTM intervention. This 5-year study compares the effectiveness of a pMTM intervention to usual care for reducing the primary outcome of MRPs, as well as the secondary outcomes of symptom burdens and acute healthcare utilization. In Aim 1, we use a hybrid type 2 RCT to quantitatively measure reach and effectiveness of the pMTM intervention. We will recruit CMC with polypharmacy and their parents within an academic center’s outpatient complex care program that serves >5600 CMC annually. In Aim 2, we will quantitatively and qualitatively examine important patient and parent characteristics that modify the effectiveness of the pMTM intervention. In Aim 3, we will assess adoption, implementation, and potential for maintenance of the pMTM intervention by healthcare providers, including program replication costs. The University of Colorado Anschutz Medical Campus provides a unique research environment enabling the conduct of pediatric polypharmacy research, supported by collaborative research partnerships between the Adult and Child Center for Health Outcomes Research and Delivery Science (ACCORDS), the Skaggs School of Pharmacy and Pharmaceutical Sciences, and the Children’s Hospital Colorado Special Care Clinic for children with medical complexity. Dr. James Feinstein, an expert in pediatric complex care and polypharmacy research, will lead an experienced team of co-investigators including, Dr. Allison Kempe (pragmatic trials and implementation science), Dr. Chris Feudtner (health services and complex care research), Dr. Lucas Orth (pediatric pharmacy), Dr. John Rice (biostatistics and longitudinal methods), Dr. Megan Morris (qualitative research), and Dr. Mark Gritz (economic analysis) to complete the proposed research. If pMTM is proven effective, it could be rapidly disseminated nationally as a model for pharmacist integration into outpatient complex care programs and it could have enormous impact on the public health of CMC by preventing medication-related safety issues, attendant morbidity, and associated costs.