Improving Communication of Medication Instructions to Parents

Not Applicable

Completed

• Conditions: Medication Adherence; Medication Errors
• Interventions: Other: HELPix

• Registration Number: NCT01834924
• Lead Sponsor: NYU Langone Health

Brief Summary

Almost half of all US adults have trouble understanding and using health information, or low health literacy. Health literacy is considered to be an important patient safety issue, and has been linked to poor medication management. Low health literacy is a risk factor for parent errors in administering medications to their children; difficulty understanding provider medication instructions is likely to contribute to errors.

To address these issues, bilingual (English/Spanish), low literacy, picture-based medication instruction sheets were developed. This study will look at the effectiveness and feasibility of the medication instruction sheet-based intervention as it is used by providers in 2 pediatric emergency department settings, as part of a planned roll out of HELPix within the hospital system. The investigators hypothesize that there will be reduced medication dosing errors, improved medication adherence, reduced hospital revisit rates, and improved provider-parent communication. The investigators also hypothesize that provider technology experience, knowledge, and attitudes, will affect the extent to which providers use the tool.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-31
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-18
• Primary Completion: 2015-01-09
• Study Completion: 2015-01-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1196

Inclusion Criteria

• child <=8 years
• child prescribed a daily dose short course (<14 day) liquid medication

Parent

Exclusion Criteria

• caregiver not legal guardian of child
• caregiver non-English/ Spanish language
• caregiver residency outside of New York City
• hospital admission of child
• child with psychiatric or child protection-related issue
• no listed phone number for caregiver
• person reached by phone not person counseled in the emergency department
• no eligible medication prescribed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HELPix	HELPix	Low literacy, bilingual (English/Spanish) medication instruction sheets used as a framework for provider medication counseling, plus provider dose demonstration, parent teachback/showback, provider medication log review, provision of oral dosing syringe to parent

Primary Outcome Measures

Name	Time	Method
Medication dosing error (observed)	within 8 weeks of the end date of prescribed course of medication	Dosing error defined as \>20% deviation from prescribed dose

Trial Locations

Locations (2)

Woodhull Hospital; 🇺🇸 Brooklyn, New York, United States

Bellevue Hospital Center; 🇺🇸 New York, New York, United States