Medication ErrorsPhase 1NCT00537433
Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention
A Phase 1 study testing Pictogram in people with Medication Errors, run by NYU Langone Health at 1 site in United States.
Trial summary
Liquid medication administration errors are common, and place children at risk for adverse events. Caregivers with low socioeconomic status (SES), low education and poor health literacy skills are at increased risk for errors. Read more about this study
- Who is it for?
- Ages 1 month to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Errors
- What is being tested?
- Pictogram
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jan 2007
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child 30 days through 8 years old
- child prescribed a liquid medication (short course (<14 days) daily dose medication or as needed (prn) medication)
Who cannot join
- caregiver accompanying child to visit not primarily responsible for administering medication to the child
- caregiver not fluent in English or Spanish
- child requiring immediate medical attention
- child who typically takes medications in tablet form
- child having a visit involving a psychiatric problem or child protection issue
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU School of Medicine Department of Pediatrics
New York, New York, 10016
About this study
Official title: An RCT to Reduce Liquid Medication Dosing Errors and Improve Adherence in Caregivers of Young Children Through a Pictogram-Based Intervention
Liquid medication administration errors are common, and place children at risk for adverse events. Caregivers with low socioeconomic status (SES), low education and poor health literacy skills are at increased risk for errors. In this study, we seek to assess whether at-risk parents who received a plain language, pictogram-based intervention would have reduced medication dosing errors and improved medication adherence.
Read the detailed description
Evidence suggests that errors by parents and caregivers in administering medications to their children are frequent. These errors, which include inaccurate dosing as well as nonadherence to medication regimens, place children at risk for morbidity and mortality. Misdosing is prevalent, with 50% or more of pediatric caregivers either measuring an incorrect dose or reporting a dose of liquid medication given outside the recommended range. Of further concern are reports of an overall poor adherence rate of 50% for pediatric medications, with implications for treatment failure and drug resistance.
Few studies have examined strategies for decreasing medication administration errors in pediatric patients. Pictograms represent a promising approach in which simple diagrams are used to improve understanding of concepts. Pictorial-enhanced written materials have been shown to improve comprehension and adherence with medical directions, particularly for patients with low literacy.
We developed a pictogram-based intervention to decrease dosing errors and improve adherence. In this study, we sought to assess whether this intervention would reduce medication dosing errors and improve adherence in a pediatric emergency room serving at-risk families.
- Conditions
- Medication Errors
- Being tested
- Pictogram
- Keywords
- Medication errors, Patient nonadherence, Literacy, Communication
- Medical subject headings
- Patient Compliance, Literacy, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PictogramOther
The plain language, pictogram-based medication instruction sheets (available in English and Spanish) utilize pictograms to convey information about the medication name, indication, dose, dose frequency, and length of treatment, along with information about preparation and storage. The sheets also include a medication log for parents to keep track of when they administer the medication.
Research staff reference the sheets as they demonstrate dosing with a standardized dosing instrument; teachback is performed to reinforce concepts. For medications in which a standardized dosing instrument was not included at dispensing, a standardized oral dosing syringe is provided for the caregiver to use at home. After counseling, the caregiver is given the instruction sheet to take home.
| Study group | Role | What they receive |
|---|---|---|
| Standard counseling | No intervention | Families in the control group receive standard care, including routine counseling regarding medications prescribed from their physician and post-visit counseling by the pediatric nursing staff. Dosing instruments are given at the discretion of the physician or nurse. |
| Pictogram | Experimental | Parents randomized to the pictogram-based intervention group receive medication counseling utilizing the pictogram-based medication instruction sheets. These sheets help to facilitate medication counseling, including teaching about dosage and adherence. Receives: Other: Pictogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Dosing Accuracy (observed and reported); Medication Adherence (reported)
Measured: Assessments by phone or in-person, planned at 3-5 days for prn medications, and within 1 day of last dose of prescribed treatment time for daily dose medications.
Secondary outcomes (1)
Medication Knowledge and Related Medication Practices (dose frequency, preparation, storage, dosing instrument use)
Measured: Assessments by phone or in-person, planned at 3-5 days for prn medications, and within 1 day of last dose of prescribed treatment time for daily dose medications.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startJul 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication ErrorsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Investigators
- Hsiang (Shonna) Yin, MD, MS, Principal investigator, NYU School of Medicine Department of PediatricsAlan L Mendelsohn, MD, Principal investigator, NYU School of Medicine Department of PediatricsBenard P Dreyer, MD, Principal investigator, NYU School of Medicine Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537433
- Sponsor's protocol ID
- IRB06-168
- Status last verified
- Sep 2007
- First submitted
- 28 Sep 2007
- Last updated
- 1 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Yin HS, Dreyer BP, van Schaick L, Foltin GL, Dinglas C, Mendelsohn AL. Randomized controlled trial of a pictogram-based intervention to reduce liquid medication dosing errors and improve adherence among caregivers of young children. Arch Pediatr Adolesc Med. 2008 Sep;162(9):814-22. doi: 10.1001/archpedi.162.9.814.
PubMed 18762597