Improving Communication of Medication Instructions to Parents

NCT01834924 | Completed

• 1 other identifier: 08-1423
• Study Type: interventional
• Target: 1,196
• Locations: 1 country
• Sites: 2

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.

Conditions

Medication Errors; Medication Adherence

Keywords

Health literacy; Patient education

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HELPix

ACTIVE COMPARATOR

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

Other: HELPix

Control

NO INTERVENTION

Standard provider medication counseling

Interventions

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

HELPix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• New York City Health and Hospitals Corporation: collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (2)

Woodhull Hospital

Brooklyn, New York, 11206, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• H. Shonna Yin, MD, MS

  NYU School of Medicine / Bellevue Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 18, 2013
• Study Start: May 31, 2010
• Primary Completion: January 9, 2015
• Study Completion: January 9, 2015
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

US (2)