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

NCT05387564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-01-07

Study results available
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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

BEHAVIORAL

SCT Documentation and Disclosure Toolkit (SCT-DD)

A toolkit of implementation strategies

Sponsors & Collaborators

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Corinna Schultz, MD, MSHP · Nemours

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2024-08-31
Completion
2024-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387564 on ClinicalTrials.gov