ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Communication of Medication Instructions to Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01834924
Recruitment Status : Active, not recruiting
First Posted : April 18, 2013
Last Update Posted : January 12, 2018
Sponsor:
Collaborators:
New York City Health and Hospitals Corporation
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
New York University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Medication Errors Medication Adherence Other: HELPix Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Dissemination of a Health Literacy Intervention to Improve Provider-Patient Communication of Medication Instructions and Decrease Outpatient Pediatric Medication Errors
Study Start Date : May 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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
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
No Intervention: Control
Standard provider medication counseling



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834924


Locations
United States, New York
Woodhull Hospital
Brooklyn, New York, United States, 11206
Bellevue Hospital Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
New York City Health and Hospitals Corporation
Robert Wood Johnson Foundation
Investigators
Principal Investigator: H. Shonna Yin, MD, MS NYU School of Medicine / Bellevue Hospital Center

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01834924     History of Changes
Other Study ID Numbers: 08-1423
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by New York University School of Medicine:
Health literacy
Patient education