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OpenTrials
Completed

NCT Number: NCT01834924

Improving Communication of Medication Instructions to Parents

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woodhull Hospital, Brooklyn, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HELPix

Other

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 outcomes

  1. Medication dosing error (observed)

    Time frame: within 8 weeks of the end date of prescribed course of medication

    Dosing error defined as >20% deviation from prescribed dose

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • New York City Health and Hospitals Corporation
  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 18, 2013
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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