Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 5:48 AM
Study NCT ID:
NCT01109459
Status:
COMPLETED
Last Update Posted:
2010-04-23
First Post:
2010-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Physician Intervention to Detect Amblyopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}, {'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-22', 'studyFirstSubmitDate': '2010-04-21', 'studyFirstSubmitQcDate': '2010-04-22', 'lastUpdatePostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preschool vision screening by primary care providers', 'timeFrame': '1 year', 'description': 'A rate: number of claims for preschool vision screening (using a billing procedure code) / number of claims for well child exams (another billng code). These procedure codes are filed by primary care providers (PCPs). Rates are determined for individual Intervention, Control and non-participating eligible PCPs.'}], 'secondaryOutcomes': [{'measure': 'Diagnosis of strabismus or amblyopia by eye specialists', 'timeFrame': '1 year', 'description': 'A rate: number of claims from eye specialists with procedure codes of strabismus or amblyopia(using billing data) / number of claims for well child exams by intervention, control and non-participating eligible PCPs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preschool', 'screening', 'cluster randomized', 'physician practice patterns', 'behavior', 'knowledge', 'attitudes', 'guideline adherence'], 'conditions': ['Amblyopia', 'Strabismus']}, 'referencesModule': {'references': [{'pmid': '22982768', 'type': 'DERIVED', 'citation': 'Marsh-Tootle WL, Frazier MG, Kohler CL, Dillard CM, Davis K, Schoenberger YM, Wall TC. Exploring pre-school vision screening in primary care offices in Alabama. Optom Vis Sci. 2012 Oct;89(10):1521-31. doi: 10.1097/OPX.0b013e318269ca9f.'}, {'pmid': '21730344', 'type': 'DERIVED', 'citation': 'Marsh-Tootle WL, McGwin G, Kohler CL, Kristofco RE, Datla RV, Wall TC. Efficacy of a web-based intervention to improve and sustain knowledge and screening for amblyopia in primary care settings. Invest Ophthalmol Vis Sci. 2011 Sep 9;52(10):7160-7. doi: 10.1167/iovs.10-6566.'}, {'pmid': '20974292', 'type': 'DERIVED', 'citation': 'Wall TC, Marsh-Tootle WL, Crenshaw K, Person SD, Datla R, Kristofco RE, Hartmann EE. Design of a randomized clinical trial to improve rates of amblyopia detection in preschool aged children in primary care settings. Contemp Clin Trials. 2011 Mar;32(2):204-14. doi: 10.1016/j.cct.2010.10.009. Epub 2010 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'Current research shows low rates of quantitative vision screening at preschool ages in the medical home. This study targets providers (PCPs) to evaluate the effectiveness of a web-based intervention to improve knowledge about strabismus, amblyopia and preschool vision screening, to increase preschool vision screening rates, and to improve rates of diagnosis of strabismus and amblyopia by eye specialists.', 'detailedDescription': 'Despite decades of research showing adverse neural consequences of abnormal vision, little has changed for amblyopic children. Over the past 40 years, data have shown that most children with amblyopia are detected late. In our health care system, primary care physicians play a pivotal role in translating findings about amblyopia into practice. But, our experience with the Maternal and Child Health Bureau (MCHB) / NEI expert panel on Vision Screening in the Preschool Child and the MCHB/ American Academy of Pediatrics (AAP) Project Universal Preschool Vision Screening revealed that primary care physicians get very little training about amblyopia and risk factors. Consequently, many do not screen aggressively for these conditions.\n\nThe University of Alabama Departments of Optometry, Pediatrics and Continuing Medical Education, in collaboration Medicaid Agencies in Alabama, South Carolina and Illinois, have developed a novel, internet-based, multi-modal strategy to increase the understanding and recognition of amblyopia and its risk factors by pediatricians and primary care physicians in office based settings. We have designed a cluster-randomized, controlled clinical trial to test whether our intervention results in improved performance by "intervention" physicians compared to control physicians (exposed to a web-based intervention for pediatric blood pressure screening and adolescent chlamydia screening). Our design, along with pre / post-intervention and control / intervention performance measures, will evaluate changes in practice attributable to the intervention versus those occurring from other sources over time. Our final analysis will show whether preschool patients of intervention physicians are more likely to be identified with strabismus or amblyopia. This research forges a critical link between the truly phenomenal body of amblyopia research fostered by the NEI and the health care offered to American children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* files Medicaid claims for at least 8 well child visits for children aged 3 or 4 years during one year,\n* files claims under individual name,\n* has internet access.\n\nExclusion Criteria:\n\n* files fewer than 8 Medicaid claims for well child visits for children aged 3 or 4 years old during one year,\n* files claims under a clinic name,\n* does not have internet access.'}, 'identificationModule': {'nctId': 'NCT01109459', 'acronym': 'EPPICC', 'briefTitle': 'Multimodal Physician Intervention to Detect Amblyopia', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Multimodal Physician Intervention to Detect Amblyopia (Recruiting Title "Equipping Primary Care Physicians to Improve Care for Children")', 'orgStudyIdInfo': {'id': 'EY015893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pediatric vision screening', 'description': 'intervention', 'interventionNames': ['Other: Pediatric vision screening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pediatric blood pressure screening', 'description': 'control', 'interventionNames': ['Other: Pediatric blood pressure screening']}, {'type': 'NO_INTERVENTION', 'label': 'Primary care providers observation only', 'description': 'Observational'}], 'interventions': [{'name': 'Pediatric blood pressure screening', 'type': 'OTHER', 'description': 'Website presenting case-based education with tailoring based on knowledge and interactive with responses collected on line. Has a tool box for office materials to promote and encourage guideline based performance.', 'armGroupLabels': ['Pediatric blood pressure screening']}, {'name': 'Pediatric vision screening', 'type': 'OTHER', 'description': 'Website presenting case-based education about amblyopia and strabismus with tailoring based on knowledge and interactive with responses collected on line. Has a tool box for office materials to promote and encourage guideline based performance.', 'armGroupLabels': ['Pediatric vision screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Wendy L Marsh-Tootle, OD,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Wendy L. Marsh-Tootle, Principal Investigator', 'oldOrganization': 'University of Alabama at Birmingham'}}}}