Multimodal Physician Intervention to Detect Amblyopia

Amblyopia Clinical Trial

— EPPICC  

Official title:

Multimodal Physician Intervention to Detect Amblyopia (Recruiting Title "Equipping Primary Care Physicians to Improve Care for Children")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109459
• Other study ID #: EY015893
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: April 22, 2010
• Start date: September 2004
• Est. completion date: October 2008

Study information

• Verified date: April 2010
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Amblyopia
• Strabismus

Intervention

Other:
• Pediatric blood pressure screening
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.
• Pediatric vision screening
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preschool vision screening by primary care providers	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	No
Secondary	Diagnosis of strabismus or amblyopia by eye specialists	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	No