NCT05387564

Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Trait

Interventions

Type	Name	Description
BEHAVIORAL	SCT Documentation and Disclosure Toolkit (SCT-DD)	A toolkit of implementation strategies

Timeline

• Start date: 2024-01-18
• Primary completion: 2024-08-31
• Completion: 2024-12-30
• First posted: 2022-05-24
• Last updated: 2026-01-07
• Results posted: 2026-01-07

Locations

1 site across 1 country: United States