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

Completed · Not applicable

Conditions studied: Sickle Cell Trait

In brief

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.

Key facts

Study ID

NCT05387564

Run by

Nemours Children's Clinic

People needed

114

Starts

2024-01-18

Expected to finish

2024-12-30

Last updated by the study team

2026-01-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatient pediatric primary care providers within Nemours and their patients

You may not qualify if…

• none

Where it is running

• Nemours Children's Hospital, Delware — Wilmington, Delaware, United States

Full record on ClinicalTrials.gov

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