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NCT05387564 · ClinicalTrials.gov registry record · NA
Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
A NA study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- NA
- Development phase
- 114
- Enrollment target
NCT05387564 is a NA study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 114 participants.
The verdict
NCT05387564, a NA study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 114 participants
- Enrollment target
Study Summary
The hemoglobinopathy newborn screen (NBS) performed on all neonates in the U.S. allows for early life-saving medical care for infants with sickle cell disease (SCD), an autosomal recessive genetic disorder. Because of its detection method, the NBS incidentally reveals hemoglobinopathy traits including sickle cell trait (SCT). In an effort to uphold the rights of the newborn to their medical data and preserve autonomy in medical decision making, pediatric and genetic society guidelines recommend disclosure and documentation of SCT results during infancy. Despite this guidance, a large guideline-to-practice gap exists: SCT status is grossly under-documented in the pediatric electronic health record and few adults report knowing their SCT status despite universal screening. We plan to evaluate the effect of a toolkit of SCT Documentation and Disclosure (SCT-DD) strategies on documentation and disclosure of SCT by pediatric primary care providers in a 2-arm randomized interrupted time series trial.
Interventions
- BEHAVIORAL SCT Documentation and Disclosure Toolkit (SCT-DD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2024-01-18 |
| Est. Completion | 2024-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05387564
The ClinicalTrials.gov registry entry for NCT05387564 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SCT Documentation and Disclosure Toolkit (SCT-DD) is the first listed.
NCT05387564 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05387564 about?
NCT05387564 is a clinical study titled "Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach". The hemoglobinopathy newborn screen (NBS) performed on all neonates in the U.S. allows for early life-saving medical care for infants with sickle cell disease (SCD), an autosomal recessive genetic disorder. Because of its detection method, the NBS incidentally reveals hemoglobinopathy traits includi...
What is the current status of trial NCT05387564?
This trial is currently completed. It is a NA study. The enrollment target is 114 participants. The study started on 2024-01-18. Estimated completion is 2024-12-30.
What interventions are being tested in trial NCT05387564?
The interventions under investigation include: SCT Documentation and Disclosure Toolkit (SCT-DD) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05387564?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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