Improving Communication of Medication Instructions to Parents

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834924
• Other study ID #: 08-1423
• Status: Completed
• Phase: N/A
• Start date: May 31, 2010
• Est. completion date: January 9, 2015

Study information

• Verified date: October 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1196
• Est. completion date: January 9, 2015
• Est. primary completion date: January 9, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence
• Medication Errors

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Woodhull Hospital	Brooklyn	New York
United States	Bellevue Hospital Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	New York City Health and Hospitals Corporation, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication dosing error (observed)	Dosing error defined as >20% deviation from prescribed dose	within 8 weeks of the end date of prescribed course of medication