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Improving Communication of Medication Instructions to Parents

Dissemination of a Health Literacy Intervention to Improve Provider-Patient Communication of Medication Instructions and Decrease Outpatient Pediatric Medication Errors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01834924
Enrollment
1196
Registered
2013-04-18
Start date
2010-05-31
Completion date
2015-01-09
Last updated
2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Adherence, Medication Errors

Keywords

Health literacy, Patient education

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.

Interventions

OTHERHELPix

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

Sponsors

New York City Health and Hospitals Corporation
CollaboratorOTHER
Robert Wood Johnson Foundation
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Parent 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

Design outcomes

Primary

MeasureTime frameDescription
Medication dosing error (observed)within 8 weeks of the end date of prescribed course of medicationDosing error defined as \>20% deviation from prescribed dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026