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

Not Applicable

Completed

• Conditions: Sickle Cell Trait
• Interventions: Behavioral: SCT Documentation and Disclosure Toolkit (SCT-DD)

• Registration Number: NCT05387564
• Lead Sponsor: Nemours Children's Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Study Start: 2024-01-18
• Primary Completion: 2024-08-31
• Status Verified: 2024-12
• Study Completion: 2024-12-30
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Outpatient pediatric primary care providers within Nemours and their patients

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
"All-in"	SCT Documentation and Disclosure Toolkit (SCT-DD)	In the "all-in" arm, pediatric primary care physicians receive all toolkit components at once.
"Add-in"	SCT Documentation and Disclosure Toolkit (SCT-DD)	In the "add-in" arm, pediatric primary care physicians will have sequential addition of toolkit components in 6 week increments

Primary Outcome Measures

Name	Time	Method
Feasibility of using toolkit components	Every 6 weeks through study completion, on average 1 year	Percent of pediatric primary care providers who use individual toolkit components by survey
Penetration	Every 1 month through study completion, on average 1 year	Rate of documentation and disclosure of NBS and SCT by 2 months of age within the medical history section of the electronic health record by chart review.
Self-efficacy	Every 6 weeks through study completion, on average 1 year	Increase in the intention and confidence to document/discuss SCT result by pediatric primary care providers by survey
Acceptability	Every 6 weeks through study completion, on average 1 year	Acceptability of toolkit components by pediatric primary care providers by survey

Secondary Outcome Measures

Name	Time	Method
Knowledge	Every 1 months through study completion, on average 1 year	Proportion of caregivers who accurately reported their child's SCT status via survey
Dispersion	Every 1 month through study completion, on average 1 year	Proportion of children over 2 months of age who have SCT newly documented within the electronic health record via chart review

Trial Locations

Locations (1)

Nemours Children's Hospital, Delware; 🇺🇸 Wilmington, Delaware, United States