NCT01109459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
Last Updated

April 23, 2010

Status Verified

April 1, 2010

Enrollment Period

4.1 years

First QC Date

April 21, 2010

Last Update Submit

April 22, 2010

Conditions

Keywords

preschoolscreeningcluster randomizedphysician practice patternsbehaviorknowledgeattitudesguideline adherence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Diagnosis of strabismus or amblyopia by eye specialists

    1 year

Study Arms (3)

Pediatric vision screening

EXPERIMENTAL

intervention

Other: Pediatric vision screening

Pediatric blood pressure screening

ACTIVE COMPARATOR

control

Other: Pediatric blood pressure screening

Primary care providers observation only

NO INTERVENTION

Observational

Interventions

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 blood pressure 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.

Pediatric vision screening

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

AmblyopiaStrabismusBehavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOcular Motility DisordersCranial Nerve Diseases

Study Officials

  • Wendy L Marsh-Tootle, OD,MS

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2010

First Posted

April 23, 2010

Study Start

September 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

April 23, 2010

Record last verified: 2010-04

Locations