- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01109459
Multimodal Physician Intervention to Detect Amblyopia (EPPICC)
Multimodal Physician Intervention to Detect Amblyopia (Recruiting Title "Equipping Primary Care Physicians to Improve Care for Children")
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35243
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- files Medicaid claims for at least 8 well child visits for children aged 3 or 4 years during one year,
- files claims under individual name,
- has internet access.
Exclusion Criteria:
- files fewer than 8 Medicaid claims for well child visits for children aged 3 or 4 years old during one year,
- files claims under a clinic name,
- does not have internet access.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pediatric vision screening
intervention
|
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.
|
Active Comparator: Pediatric blood pressure screening
control
|
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.
|
No Intervention: Primary care providers observation only
Observational
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
preschool vision screening by primary care providers
Time Frame: 1 year
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of strabismus or amblyopia by eye specialists
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wendy L Marsh-Tootle, OD,MS, University of Alabama at Birmingham
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EY015893
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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