Back to resultsAssuring Ophthalmologic Follow up
Primary Purpose
Vision Screening, Amblyopia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active scheduling
Sponsored by
About this trial
This is an interventional health services research trial for Vision Screening
Eligibility Criteria
Inclusion Criteria:
- All pediatrics patients without pre-existing vision problems undergoing instrument vision screening at DH Pediatric CGP Clinics in at ages 2,3,4,5, and 6 years of age.
Exclusion Criteria:
- All pediatric patients with pre-existing eye problems that would cause them to be excluded from the study.
- All patients of parents who choose to go to an eyecare provider other than the one participating in the study (as we would be unable to make appointments or track appointments).
- All patients of parents who refuse to make an appointment
Sites / Locations
- Darmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active scheduling
Arm Description
Children who fail instrument vision screens will be scheduled at a community vision specialist office before departure from clinic and all no shows at the vision specialist office will be tracked and rescheduled.
Outcomes
Primary Outcome Measures
Number of children who complete vision evaluation
Number of children who complete vision evaluation with vision specialist
Secondary Outcome Measures
Number of children with amblyopia or pre amblyopic strabismus identified and treated
Number of children with amblyopia or pre amblyopic strabismus identified and treated with a vision specialist.
Full Information
NCT ID
NCT04959422
First Posted
July 2, 2021
Last Updated
July 13, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04959422
Brief Title
Assuring Ophthalmologic Follow up
Official Title
Assuring Ophthalmologic Follow up for Children Referred Following Instrument-based Vision Screening in a Pediatric Clinic: Effect of Immediate Referral Scheduling and Tracking
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were enrolled in the study, and staff has been reduced and cannot support the trial any longer.
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to quantify the improvement in completed ophthalmology referrals and quantify the number of children identified and treated for amblyopia or pre amblyopic strabismus resulting from the implementation of a new referral and tracking system.
Detailed Description
Children who fail instrument vision screens at Dartmouth Hitchcock (D-H) Community Group Practice (CGP) Pediatric Clinics will be scheduled at a community vision specialist office before departure from the Pediatric clinic. If the patient does not attend the appointment (a no show) at the vision specialist office , this will be tracked and the patient will be rescheduled.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Screening, Amblyopia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active scheduling
Arm Type
Experimental
Arm Description
Children who fail instrument vision screens will be scheduled at a community vision specialist office before departure from clinic and all no shows at the vision specialist office will be tracked and rescheduled.
Intervention Type
Other
Intervention Name(s)
Active scheduling
Intervention Description
Active scheduling, tracking and rescheduling, if necessary.
Primary Outcome Measure Information:
Title
Number of children who complete vision evaluation
Description
Number of children who complete vision evaluation with vision specialist
Time Frame
Approximately 1 year
Secondary Outcome Measure Information:
Title
Number of children with amblyopia or pre amblyopic strabismus identified and treated
Description
Number of children with amblyopia or pre amblyopic strabismus identified and treated with a vision specialist.
Time Frame
Approximately 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All pediatrics patients without pre-existing vision problems undergoing instrument vision screening at DH Pediatric CGP Clinics in at ages 2,3,4,5, and 6 years of age.
Exclusion Criteria:
All pediatric patients with pre-existing eye problems that would cause them to be excluded from the study.
All patients of parents who choose to go to an eyecare provider other than the one participating in the study (as we would be unable to make appointments or track appointments).
All patients of parents who refuse to make an appointment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J Schuman
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Darmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plan to share IPD at this time.
Learn more about this trial
Assuring Ophthalmologic Follow up
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