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

Sickle Cell Trait Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387564
• Other study ID #: 348506
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Nemours Children's Clinic
• Contact: Corinna Schultz, MD, MSHP
• Phone: 3023313088
• Email: corinna.schultz[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Outpatient pediatric primary care providers within Nemours and their patients

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Sickle Cell Trait

Intervention

Behavioral:
• SCT Documentation and Disclosure Toolkit (SCT-DD)
A toolkit of implementation strategies

Locations

Country	Name	City	State
United States	Nemours Children's Hospital, Delware	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penetration	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.	Every 1 month through study completion, on average 1 year
Primary	Acceptability	Acceptability of toolkit components by pediatric primary care providers by survey	Every 6 weeks through study completion, on average 1 year
Primary	Self-efficacy	Increase in the intention and confidence to document/discuss SCT result by pediatric primary care providers by survey	Every 6 weeks through study completion, on average 1 year
Primary	Feasibility of using toolkit components	Percent of pediatric primary care providers who use individual toolkit components by survey	Every 6 weeks through study completion, on average 1 year
Secondary	Dispersion	Proportion of children over 2 months of age who have SCT newly documented within the electronic health record via chart review	Every 1 month through study completion, on average 1 year
Secondary	Knowledge	Proportion of caregivers who accurately reported their child's SCT status via survey	Every 1 months through study completion, on average 1 year