Improving Communication of Medication Instructions to Parents

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.

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

Conditions
-----------------
Medication Errors, Medication Adherence

Intervention / Treatment
-----------------
* Other: HELPix


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HELPix<br>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<br>* 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<br>|
| No Intervention: Control<br>Standard provider medication counseling | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health literacy, Patient education