Grant Number:	1R01CA283501-01A1 Interpret this number
Primary Investigator:	Bouchard, Elizabeth
Organization:	Roswell Park Cancer Institute Corp
Project Title:	MEDSUPPORT: a Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication
Fiscal Year:	2024

Pediatric nonadherence to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Participants in our previous studies have described medication adherence as “one of the most stressful parts” of pediatric cancer caregiving, and we found that 93% of parents experience barrier(s) to medication administration. We have designed MedSupport, a theory-based multilevel intervention that is designed to address root barriers to medication adherence. In Aim 1 we will determine if the MedSupport intervention increases the proportion of patients with chemotherapy adherence 95% or higher. Our study design leverages a unique opportunity as a companion study for an upcoming therapeutic trial and will enroll at 8 pediatric cancer programs. This will enhance methodological rigor through leveraging robust clinical trial infrastructure to achieve multi-site recruitment in diverse geographic and clinical sites. We will recruit families of pediatric patients with ALL (N = 150) on home-based chemotherapy. Families will be randomized 1:1 to (1) the MedSupport intervention and (2) usual care with standardized education control. We will use both MEMS electronic medication monitoring and innovative biomarkers of drug metabolites to measure adherence. In Aim 2 we will test a theory-based mechanism of intervention effectiveness. These results will increase conceptual significance through rigorous examination of mechanisms of action of the MedSupport intervention to inform future intervention optimization and translation. In Aim 3 we will use the Implementation Outcomes Framework to examine implementation effectiveness to enhance future dissemination of the MedSupport intervention. We will examine the relationship between implementation quality on intervention effectiveness (Aim 3a) and strategies that may hinder or support uptake within routine care to inform future implementation strategies (Aim 3b). Our design incorporates numerous elements that substantially increase rigor and reproducibility including leveraging a large therapeutic trial for multi-site participant recruitment and rigorous measurement of adherence through objective behavioral measures (electronic medication monitoring) and pharmacological measures (validated biomarkers of drug metabolites). Findings will make significant conceptual contributions through examining how the MedSupport intervention works to pave the way for future intervention optimization. Findings will have significant translational impact through examining implementation effectiveness to enhance future dissemination of the MedSupport intervention. Upon completion of this research, we will have an innovative, low-cost, and scalable intervention to enhance home-based medication adherence in pediatric cancer that is ready to be translated to clinical practice. While this study focuses on pediatric ALL, the MedSupport intervention has potential for high impact in numerous pediatric diseases.





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