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

Clinical Trial
Study Details
Enrollment
114
Interventions
Description

A toolkit of implementation strategies

Name
SCT Documentation and Disclosure Toolkit (SCT-DD)
Type
Behavioral
Phase
N/A
Status
COMPLETED
Study ID #
NCT05387564
Study Type
Interventional
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.

Study Overview
Conditions
Contacts and Locations
Locations
Facility

Nemours Children's Hospital, Delware
Wilmington, Delaware 19803
United States

GeoPoint
39.74595, -75.54659