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Improving Communication of Medication Instructions to Parents

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by New York University School of Medicine
Sponsor:
Collaborators:
New York City Health and Hospitals Corporation
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01834924
First received: April 15, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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 Intervention
Medication Errors
Medication Adherence
Other: HELPix

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Medication dosing error (observed) [ Time Frame: within 8 weeks of the end date of prescribed course of medication ] [ Designated as safety issue: Yes ]
    Dosing error defined as >20% deviation from prescribed dose


Estimated Enrollment: 16000
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834924

Contacts
Contact: H. Shonna Yin, MD, MS 212-562-2821 yinh02@med.nyu.edu

Locations
United States, New York
Woodhull Hospital Recruiting
Brooklyn, New York, United States, 11206
Contact: H. Shonna Yin, MD    212-562-2821    yinh02@med.nyu.edu   
Sub-Investigator: Luis Rodriguez, MD         
Bellevue Hospital Center Recruiting
New York, New York, United States, 10016
Contact: H. Shonna Yin, MD, MS    212-562-2821    yinh02@med.nyu.edu   
Sub-Investigator: Alan L Mendelsohn, MD         
Sub-Investigator: Benard P Dreyer, MD         
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
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01834924     History of Changes
Other Study ID Numbers: 08-1423
Study First Received: April 15, 2013
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014