Идёт набор NCT04278690

Supporting Safe Use of Medications by Parents After Infant Discharge From the Neonatal Intensive Care Unit

Без фазы С лечением Medication Administered in Error

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: HELPix, HELPix+Tech.
Кому может быть актуально: Состояния в реестре: Medication Administered in Error. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Controlled Study of a Health Literacy-informed Technology-based Approach to Support Safe Medication Use by Parents After Discharge of Infants From the Neonatal Intensive Care Unit.

Обзор

This is a randomized controlled study of parents of children to be discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. A total of 425 subjects will be recruited across two sites over preparatory phases and two primary study phases.

Подробное описание

Our overarching goal is to promote safe medication use/adherence for high-risk infants, by leveraging health literacy approaches and mobile technology to reinforce provider counseling and support parent medication management after discharge from the NICU. We will adapt/integrate evidence-based strategies studied in less complex populations, for this vulnerable group. The HELPix (Health Education and Literacy for Parents) pictogram-based intervention, developed by our team, incorporates these strategies, with sizeable improvements found in medication knowledge, dosing errors, and adherence in outpatient general pediatric settings, but to date, HELPix has not been studied in NICU settings

Вмешательства

Другое HELPix
HELPix parents will receive usual care as above, after which trained staff will generate HELPix patient-/regimen-specific medication instruction sheets and review them with the parent. Instruction sheets include optimized instructions (mL-only, doses appropriately rounded, visuals of recommended tool (e.g. 1-mL syringe best for doses of \<1 mL), explicit frequency information (e.g. 'morning and night' instead of '2x/day') reinforced by pictograms (e.g. sun/moon icons)). For each medication, staf
Другое HELPix+Tech
After parent receives usual care and HELPix , trained staff will walk parent through the app on-boarding process to overcome initial barriers to use. Steps: 1) Parent texted link to personalized on-line instructions. 2) Parent clicks link to app. For each medicine: A. Dosing module with optimized instructions (c/w HELPix); parent teachback/showback of dose B. Frequency module supports simplified, explicit intervals (e.g. 'morning and night'), parent chooses convenient times (text reminders sent

Первичные конечные точки

Improvement in Dosing with HELPix+TECH and HELPix in comparison to usual care. [Срок оценки: Visit 3 (Day 30)]
Improvement in medication adherence with HELPix+TECH and HELPix in comparison to usual care [Срок оценки: Visit 3 (Day 30)]

Критерии участия

Критерии включения

English or Spanish-speaking
18 years of age and older
Child discharged home with a Rx for >1 daily liquid medication (other than multivitamin)
Primary person who will administers child's medications.
Willingness and ability to participate