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.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Improvement in Dosing with HELPix+TECH and HELPix in comparison to usual care.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Does not have a working phone number
- •Does not have access to internet (via computer/smartphone)
- •Does not have a mobile phone that receives texts.
- •Not able to return to the hospital for their child's follow-up visit
- •Visual acuity worse than 20/50 according to the Rosenbaum Pocket Screener
- •Uncorrectable hearing impairment
研究组 & 干预措施
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.
干预措施: HELPix (Other)
Usual Care
Current usual care includes standard discharge counseling by a nurse, with or without additional MD counseling.
HELPix+Tech
After parent receives usual care and HELPix (as above), 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
干预措施: HELPix+Tech (Other)
结局指标
主要结局
Improvement in Dosing with HELPix+TECH and HELPix in comparison to usual care.
时间窗: Visit 3 (Day 30)
HELPix (health literacy-informed written materials and verbal counseling in addition to usual care) and HELPix+TECH (a health literacy-informed web application in addition to HELPix and usual care) will result in improved dosing compared to usual care alone. This will be assessed by the percentage of observed dosing error (whether clinically meaningful errors of \>20% deviation and/or large error of \>40% deviation).
Improvement in medication adherence with HELPix+TECH and HELPix in comparison to usual care
时间窗: Visit 3 (Day 30)
HELPix (health literacy-informed written materials and verbal counseling in addition to usual care) and HELPix+TECH (a health literacy-informed web application in addition to HELPix and usual care) will result in improved medication adherence compared to usual care alone. This will be assessed by the percentage of poor medication adherence (\>20% deviation from # prescribed doses).
次要结局
未报告次要终点