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N/A N=28 Randomized Health Services Research

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

Sickle Cell Trait

Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Acceptability — 11; 8; 11; 8 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SCT Documentation and Disclosure Toolkit (SCT-DD) (Behavioral)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Nemours Children's Clinic
Primary completion
Aug 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Acceptability
11; 8; 11; 8; 10; 5
PRIMARY
Self-efficacy
8.55; 8.20; 8.27; 8.8; 8.73; 8.89
PRIMARY
Feasibility of Using Toolkit Components
13; 10; 12; 9; 11; 8
PRIMARY
Penetration
424; 303; 167; 179; 9; 13
SECONDARY
Knowledge
14; 15; 6; 18; 0; 2

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.

Eligibility Criteria

Inclusion Criteria

  • Outpatient pediatric primary care providers within Nemours and their patients

Exclusion Criteria

  • none
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05387564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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