Multimodal Physician Intervention to Detect Amblyopia

NCT ID: NCT01109459

Last Updated: 2010-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-10-31

Brief 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.

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.

Conditions

Amblyopia; Strabismus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Pediatric vision screening

intervention

Group Type: EXPERIMENTAL

Pediatric vision screening

Intervention Type: OTHER

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.

Pediatric blood pressure screening

control

Group Type: ACTIVE_COMPARATOR

Pediatric blood pressure screening

Intervention Type: OTHER

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.

Primary care providers observation only

Observational

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

University of Alabama at Birmingham

Principal Investigators

Wendy L Marsh-Tootle, OD,MS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22982768 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21730344 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20974292 (View on PubMed)

Other Identifiers

EY015893

Identifier Type: -

Identifier Source: org_study_id