Improving Communication of Medication Instructions to Parents

NCT ID: NCT01834924

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-01-09

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

HELPix

Intervention Type: 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

Control

Standard provider medication counseling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York City Health and Hospitals Corporation

OTHER

Sponsor Role: collaborator

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

H. Shonna Yin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine / Bellevue Hospital Center

Locations

Woodhull Hospital

Brooklyn, New York, United States

Bellevue Hospital Center

New York, New York, United States

Countries

United States

Other Identifiers

08-1423

Identifier Type: -

Identifier Source: org_study_id