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

Medication Administered in Error Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278690
• Other study ID #: 19-01294
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: Hsiang Shonna Yin
• Phone: 646-501-4284
• Email: hsiang.yin[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 425
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. English or Spanish-speaking

2. 18 years of age and older

3. Child discharged home with a Rx for >1 daily liquid medication (other than multivitamin)

4. Primary person who will administers child's medications.

5. Willingness and ability to participate

Exclusion Criteria:

1. Does not have a working phone number

2. Does not have access to internet (via computer/smartphone)

3. Does not have a mobile phone that receives texts.

4. Not able to return to the hospital for their child's follow-up visit

5. Visual acuity worse than 20/50 according to the Rosenbaum Pocket Screener

6. Uncorrectable hearing impairment

Related Conditions & MeSH terms

• Medication Administered in Error

Intervention

Other:
• 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, staff will: 1) review the dose (refer to the pictographic dose diagram, which illustrates optimal dosing tool filled to correct amount), 2) demonstrate the dose using optimal dosing tool, 3) ask parent to 'teachback'/'showback' dose (e.g. parent shows provider how much they would give by pulling back plunger on syringe to right level), 4) provide optimal dosing tool for the parent to take home. We anticipate this process will take ~5-10 minutes.
• 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 based on preferences). Time for TECH depends on # medicines and parent baseline knowledge; structured protocol used to see # teachback rounds needed .

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Dosing with HELPix+TECH and HELPix in comparison to usual care.	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).	Visit 3 (Day 30)
Primary	Improvement in medication adherence with HELPix+TECH and HELPix in comparison to usual care	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).	Visit 3 (Day 30)