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Clinical Trials/NCT01834924
NCT01834924CompletedNot Applicable

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

NYU Langone Health3 sites in 1 country1,196 target enrollmentStarted: May 31, 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,196
Locations
3
Primary Endpoint
Medication dosing error (observed)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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