Grant Details
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 |
Abstract
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.
Publications
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