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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: Completed NA study, sponsored by Nemours Children's Clinic.
NCT05387564 is a NA study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 114 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Acceptability of toolkit components by pediatric primary care providers by survey at the end of the study (i.e. 18 weeks after initial roll-out of interventions). Reported as the number who answered Agree or Strongly Agree on a 4-point Likert scale that they liked the toolkit component. Likert scale options included strong disagree, disagree, agree, strongly agree.
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 |
What the finished NCT05387564 record still lists
NCT05387564 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which SCT Documentation and Disclosure Toolkit (SCT-DD) is the first listed.
NCT05387564 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05387564's enrollment target sits among peer trials
114 811th of 2000 higher than 1,188 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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