Infants discharged from the neonatal intensive care unit (NICU) are at high risk for medication-related adverse events. These medically complex infants are often under treatment for multiple conditions conditions, with ~50% discharged home with >1 medication. Two-thirds of parents make medication errors post-NICU discharge, increasing the risk of morbidity. Underdosing/non-adherence can lead to therapeutic failure; overdosing can cause serious adverse effects. The small size/relative physiologic immaturity of these infants renders them less tolerant of even small dosing errors. These errors may be compounded by low health literacy and limited English Proficiency; in addition, stress associated with having a preterm infant contributes to a reduced capacity to manage the cognitive load associated with executing complex post-dischage instructions. The FDA and American Academy of Pediatrics have recognized the complexity of liquid medication administration and the potentially serious implications of errors. Addressing these issues in NICU graduates is important given the high prevalence and potential morbidity associated with errors. Incorporating key health literacy-informed communication strategies (dose demonstration, pictures, teachback) into provider counseling leads to sizeable improvements in medication knowledge, dosing errors, and adherence in the general pediatric population. To date, these strategies have not been studied in the NICU setting. The complexity of medication management in this high risk group may also require more intensive strategies; studies have shown that technology-based strategies can support patient adherence to provider instructions at home, but there has been limited study with NICU graduates. The primary objective of this application is to promote safe medication use/adherence for high risk infants, by leveraging health literacy-informed approaches and mobile health technology to reinforce provider medication counseling and support parent medication management after NICU discharge. We will study HELPix, adapted for NICU graduates, and determine if there is added benefit of HELPix enhancement with TECH (Technology Enhanced Communication in the Home). Existing HELPix components include: 1) low literacy patient-/regimen-specific instruction sheets with optimized instructions [metric-only (mL), doses appropriately rounded, pictographic dose diagram, explicit dosing intervals], 2) dose demonstration, 3) teachback/showback, 4) provision of dosing tool. TECH components include: parent access to health literacy-informed instructions via smartphones post-discharge (i.e. pictographic dose diagrams, animated dose demos, `virtual' teachback/ showback) and automated dosing reminders. The study will utilize a 3-arm RCT (HELPix+TECH vs. HELPix vs. usual care alone) in the NICU, with these aims: 1) Examine the degree to which HELPix and HELPix+TECH improve parent medication dosing and adherence compared to usual care, 2) Examine whether HELPix and HELPix+TECH can reduce disparities in parent medication dosing and adherence by parent health literacy level (HL) and English Proficiency, 3) Explore if HELPix and HELPix+TECH reduces preventable adverse events.
Numerous studies document that parent medication dosing errors and non-adherence are prevalent problems; these issues are particularly concerning for infants discharged from the neonatal intensive care unit (NICU), who are often medically complex and under treatment for multiple chronic conditions, who are typically prescribed liquid medications with small dose volumes, and whose small size and relative physiologic immaturity renders them less tolerant of errors. Recent Food and Drug Administration guidance, and an American Academy of Pediatrics policy statement, acknowledge the complexity of liquid medication administration and the potentially serious implications of errors. We will examine whether a health literacy- informed intervention that incorporates best practices in provider medication counseling, provided at the time of hospital discharge, can reduce dosing errors and improve adherence, and assess the added benefit of a mobile health (mHealth) technology-based approach that reinforces these best practices and provides longitudinal support post-NICU discharge.
