N/A
N=28
Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
Sickle Cell Trait
Bottom Line
View on ClinicalTrials.gov: NCT05387564 ↗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
| Outcome | Result | p-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
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.