Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-09 @ 5:16 AM
Study NCT ID:
NCT00537433
Status:
COMPLETED
Last Update Posted:
2007-10-01
First Post:
2007-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D000067010', 'term': 'Literacy'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-28', 'studyFirstSubmitDate': '2007-09-28', 'studyFirstSubmitQcDate': '2007-09-28', 'lastUpdatePostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Dosing Accuracy (observed and reported); Medication Adherence (reported)', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'Medication Knowledge and Related Medication Practices (dose frequency, preparation, storage, dosing instrument use)', 'timeFrame': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medication errors', 'Patient nonadherence', 'Literacy', 'Communication'], 'conditions': ['Medication Errors']}, 'referencesModule': {'references': [{'pmid': '18762597', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nFew 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child 30 days through 8 years old\n* child prescribed a liquid medication (short course (\\<14 days) daily dose medication or as needed (prn) medication)\n\nExclusion Criteria:\n\n* caregiver accompanying child to visit not primarily responsible for administering medication to the child\n* caregiver not fluent in English or Spanish\n* child requiring immediate medical attention\n* child who typically takes medications in tablet form\n* child having a visit involving a psychiatric problem or child protection issue'}, 'identificationModule': {'nctId': 'NCT00537433', 'briefTitle': 'Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'An RCT to Reduce Liquid Medication Dosing Errors and Improve Adherence in Caregivers of Young Children Through a Pictogram-Based Intervention', 'orgStudyIdInfo': {'id': 'IRB06-168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard counseling', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Pictogram', 'description': '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.', 'interventionNames': ['Other: Pictogram']}], 'interventions': [{'name': 'Pictogram', 'type': 'OTHER', 'description': '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.\n\nResearch 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.', 'armGroupLabels': ['Pictogram']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU School of Medicine Department of Pediatrics', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Hsiang (Shonna) Yin, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine Department of Pediatrics'}, {'name': 'Alan L Mendelsohn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine Department of Pediatrics'}, {'name': 'Benard P Dreyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine Department of Pediatrics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}}}}