- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04959422
Assuring Ophthalmologic Follow up
July 13, 2023 updated by: Andrew J. Schuman, Dartmouth-Hitchcock Medical Center
Assuring Ophthalmologic Follow up for Children Referred Following Instrument-based Vision Screening in a Pediatric Clinic: Effect of Immediate Referral Scheduling and Tracking
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrew J Schuman, MD
- Phone Number: 603-289-0463
- Email: Andrew.J.Schuman@hitchcock.org
Study Locations
-
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Darmouth-Hitchcock Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 6 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active scheduling
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.
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Active scheduling, tracking and rescheduling, if necessary.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of children who complete vision evaluation
Time Frame: Approximately 1 year
|
Number of children who complete vision evaluation with vision specialist
|
Approximately 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of children with amblyopia or pre amblyopic strabismus identified and treated
Time Frame: Approximately 1 year
|
Number of children with amblyopia or pre amblyopic strabismus identified and treated with a vision specialist.
|
Approximately 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew J Schuman, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2023
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
July 2, 2021
First Submitted That Met QC Criteria
July 2, 2021
First Posted (Actual)
July 13, 2021
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY02000101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are no plan to share IPD at this time.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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