Multimodal Physician Intervention to Detect Amblyopia (EPPICC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01109459
First received: April 21, 2010
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Amblyopia
Strabismus
Other: Pediatric blood pressure screening
Other: Pediatric vision screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Multimodal Physician Intervention to Detect Amblyopia (Recruiting Title "Equipping Primary Care Physicians to Improve Care for Children")

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • preschool vision screening by primary care providers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Diagnosis of strabismus or amblyopia by eye specialists [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 136
Study Start Date: September 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pediatric vision screening
intervention
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.
Active Comparator: Pediatric blood pressure screening
control
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.
No Intervention: Primary care providers observation only
Observational

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109459

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35243
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Wendy L Marsh-Tootle, OD,MS University of Alabama at Birmingham
  More Information

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wendy L. Marsh-Tootle, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01109459     History of Changes
Other Study ID Numbers: EY015893
Study First Received: April 21, 2010
Last Updated: April 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
preschool
screening
cluster randomized
physician practice patterns
behavior
knowledge
attitudes
guideline adherence

Additional relevant MeSH terms:
Amblyopia
Strabismus
Brain Diseases
Central Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Ocular Motility Disorders
Sensation Disorders
Signs and Symptoms
Vision Disorders

ClinicalTrials.gov processed this record on October 22, 2014